<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02258477</url>
  </required_header>
  <id_info>
    <org_study_id>14-1485</org_study_id>
    <nct_id>NCT02258477</nct_id>
  </id_info>
  <brief_title>A Pilot Study: Snacking, Willpower and Glucose Availability</brief_title>
  <acronym>SWG</acronym>
  <official_title>A Pilot Study: Snacking, Willpower and Glucose Availability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johnson &amp; Johnson</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a&#xD;
      non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test&#xD;
      whether there is a threshold of glucose that will result in improved ease of resistance to&#xD;
      problem foods (tested by comparing three different levels of glucose).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ingestion of 100 calories of glucose during individually pre-determined times of waning&#xD;
      dietary self-control will result in improved ease of resistance to problem foods when&#xD;
      compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Responses to the Control of Eating Questionnaire</measure>
    <time_frame>4 weeks</time_frame>
    <description>Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked &quot;what one food makes it most difficult for you to control eating?&quot; and question #10 asked &quot; What time are you particularly vulnerable to this one food.&quot; Higher ratings are consistent with a more significant or more frequent outcome.&#xD;
Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.&#xD;
Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Willpower</condition>
  <arm_group>
    <arm_group_label>Sequence 1 (D-B-A-C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2 (A-D-C-B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3 (C-A-B-D)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4 (B-C-D-A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sequence 1</intervention_name>
    <description>100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.</description>
    <arm_group_label>Sequence 1 (D-B-A-C)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sequence 2</intervention_name>
    <description>Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.</description>
    <arm_group_label>Sequence 2 (A-D-C-B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sequence 3</intervention_name>
    <description>50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.</description>
    <arm_group_label>Sequence 3 (C-A-B-D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sequence 4</intervention_name>
    <description>10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.</description>
    <arm_group_label>Sequence 4 (B-C-D-A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females ages 18 - 65 years.&#xD;
&#xD;
          2. Self-identify as regular snackers, with a specific problem food, who have trouble with&#xD;
             over-consuming this snack food.&#xD;
&#xD;
          3. Have intentionally lost weight in the last year and are seeking to maintain that&#xD;
             weight loss or have unintentionally gained weight in the last year and are concerned&#xD;
             about it.&#xD;
&#xD;
          4. Generally healthy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or trying to become pregnant.&#xD;
&#xD;
          2. Diagnosis of type 1 or type 2 diabetes&#xD;
&#xD;
          3. Not willing or able to follow study guidelines (ie: consuming the study beverage daily&#xD;
             for four weeks, or completing daily compliance logs)&#xD;
&#xD;
          4. Current smoker (or has stopped smoking within the last 6 months)&#xD;
&#xD;
          5. Taking medications that could cause weight loss or weight gain (such as steroids,&#xD;
             tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the&#xD;
             counter weight loss agents, etc).&#xD;
&#xD;
          6. Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating&#xD;
             disorder)&#xD;
&#xD;
          7. Current alcohol or drug abuse or dependence&#xD;
&#xD;
          8. Any medical condition for which daily snacking of such problem foods would be&#xD;
             inadvisable (i.e.: a subject with hypertension advised to avoid sodium).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James O Hill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anschutz Health and Wellness Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anschutz Health and Wellness Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hand GA, Shook RP, Paluch AE, Baruth M, Crowley EP, Jaggers JR, Prasad VK, Hurley TG, Hebert JR, O'Connor DP, Archer E, Burgess S, Blair SN. The energy balance study: the design and baseline results for a longitudinal study of energy balance. Res Q Exerc Sport. 2013 Sep;84(3):275-86. doi: 10.1080/02701367.2013.816224.</citation>
    <PMID>24261006</PMID>
  </reference>
  <reference>
    <citation>Chang SH, Pollack LM, Colditz GA. Life Years Lost Associated with Obesity-Related Diseases for U.S. Non-Smoking Adults. PLoS One. 2013 Jun 18;8(6):e66550. doi: 10.1371/journal.pone.0066550. Print 2013.</citation>
    <PMID>23823705</PMID>
  </reference>
  <reference>
    <citation>Dulloo AG. Explaining the failures of obesity therapy: willpower attenuation, target miscalculation or metabolic compensation? Int J Obes (Lond). 2012 Nov;36(11):1418-20. doi: 10.1038/ijo.2012.114. No abstract available.</citation>
    <PMID>23147189</PMID>
  </reference>
  <reference>
    <citation>Masicampo EJ, Baumeister RF. Toward a physiology of dual-process reasoning and judgment: lemonade, willpower, and expensive rule-based analysis. Psychol Sci. 2008 Mar;19(3):255-60. doi: 10.1111/j.1467-9280.2008.02077.x.</citation>
    <PMID>18315798</PMID>
  </reference>
  <reference>
    <citation>Littell, Ramon C., George A. Milliken, Walter W. Stroup, Russell D. Wolfinger, and O Schabenberger. 2006. SAS@ for Mixed Models, Second Edition. Cary, NC: SAS Institute.</citation>
  </reference>
  <results_reference>
    <citation>Gailliot MT, Baumeister RF. The physiology of willpower: linking blood glucose to self-control. Pers Soc Psychol Rev. 2007 Nov;11(4):303-27. doi: 10.1177/1088868307303030.</citation>
    <PMID>18453466</PMID>
  </results_reference>
  <results_reference>
    <citation>Hofmann W, Adriaanse M, Vohs KD, Baumeister RF. Dieting and the self-control of eating in everyday environments: an experience sampling study. Br J Health Psychol. 2014 Sep;19(3):523-39. doi: 10.1111/bjhp.12053. Epub 2013 Jun 10.</citation>
    <PMID>23751109</PMID>
  </results_reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>October 7, 2015</results_first_submitted>
  <results_first_submitted_qc>February 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 4, 2016</results_first_posted>
  <last_update_submitted>February 4, 2016</last_update_submitted>
  <last_update_submitted_qc>February 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited using study flyers and the study was posted on the Center website.</recruitment_details>
      <pre_assignment_details>Note, that each subject participated in the study for four weeks, consuming a different study beverage daily for one week, being crossed-over to another beverage the following week. Thus a total of 33 subjects completed all four weeks of the cross-over study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sequence 1 (D-B-A-C)</title>
          <description>Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.</description>
        </group>
        <group group_id="P2">
          <title>Sequence 2 (A-D-C-B)</title>
          <description>Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.</description>
        </group>
        <group group_id="P3">
          <title>Sequence 3 (C-A-B-D)</title>
          <description>Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.</description>
        </group>
        <group group_id="P4">
          <title>Sequence 4 (B-C-D-A)</title>
          <description>Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (1 Week)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention (1 Week)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Intervention (1 Week)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Fourth Intervention (1 Week)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>37 subjects were screened and enrolled into the study. Each subject was randomized to a different sequence of consumption of the weekly study beverage. 33 subjects completed the 4 week study.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Subjects</title>
          <description>Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.6" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Responses to the Control of Eating Questionnaire</title>
        <description>Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked &quot;what one food makes it most difficult for you to control eating?&quot; and question #10 asked &quot; What time are you particularly vulnerable to this one food.&quot; Higher ratings are consistent with a more significant or more frequent outcome.&#xD;
Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).</description>
        <time_frame>4 weeks</time_frame>
        <population>33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
          <group group_id="O2">
            <title>100 Calorie Glucose Beverage</title>
            <description>Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week.</description>
          </group>
          <group group_id="O3">
            <title>50 Calorie Beverage</title>
            <description>Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
          <group group_id="O4">
            <title>10 Calorie</title>
            <description>Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Responses to the Control of Eating Questionnaire</title>
          <description>Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked &quot;what one food makes it most difficult for you to control eating?&quot; and question #10 asked &quot; What time are you particularly vulnerable to this one food.&quot; Higher ratings are consistent with a more significant or more frequent outcome.&#xD;
Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).</description>
          <population>33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question 1: frequency of food cravings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.1"/>
                    <measurement group_id="O2" value="5.2" spread="2.7"/>
                    <measurement group_id="O3" value="5.1" spread="2.4"/>
                    <measurement group_id="O4" value="5.2" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2: strength of cravings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="2.3"/>
                    <measurement group_id="O2" value="5.0" spread="2.6"/>
                    <measurement group_id="O3" value="4.8" spread="2.6"/>
                    <measurement group_id="O4" value="5.1" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3: difficulty to resisit cravings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2.5"/>
                    <measurement group_id="O2" value="5.2" spread="2.8"/>
                    <measurement group_id="O3" value="5.0" spread="2.6"/>
                    <measurement group_id="O4" value="5.5" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4: frequency of eating due to cravings</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.8"/>
                    <measurement group_id="O2" value="4.8" spread="2.6"/>
                    <measurement group_id="O3" value="5.1" spread="2.4"/>
                    <measurement group_id="O4" value="4.9" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 5: Freq of cravings for chocolate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.4"/>
                    <measurement group_id="O2" value="4.0" spread="2.7"/>
                    <measurement group_id="O3" value="3.9" spread="2.6"/>
                    <measurement group_id="O4" value="4.6" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 6: Freq of cravings for other sweet foods</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="2.6"/>
                    <measurement group_id="O2" value="4.5" spread="2.8"/>
                    <measurement group_id="O3" value="4.5" spread="2.8"/>
                    <measurement group_id="O4" value="4.6" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 7: Freq of cravings for fruit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.7"/>
                    <measurement group_id="O2" value="2.9" spread="2.0"/>
                    <measurement group_id="O3" value="2.7" spread="1.8"/>
                    <measurement group_id="O4" value="2.9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 8: Freq of cravings for savory foods</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.1"/>
                    <measurement group_id="O2" value="4.3" spread="2.3"/>
                    <measurement group_id="O3" value="4.6" spread="2.3"/>
                    <measurement group_id="O4" value="4.7" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 11: Freq of eating problem food</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.6"/>
                    <measurement group_id="O2" value="4.9" spread="3.2"/>
                    <measurement group_id="O3" value="4.6" spread="2.9"/>
                    <measurement group_id="O4" value="4.8" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 12: Difficulty resisting problem food</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="2.5"/>
                    <measurement group_id="O2" value="6.4" spread="3.1"/>
                    <measurement group_id="O3" value="5.5" spread="2.9"/>
                    <measurement group_id="O4" value="6.2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 13: Difficulty controlling eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="1.8"/>
                    <measurement group_id="O2" value="5.8" spread="2.9"/>
                    <measurement group_id="O3" value="5.9" spread="2.5"/>
                    <measurement group_id="O4" value="5.5" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 14: Freq of snacking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.4"/>
                    <measurement group_id="O2" value="6.0" spread="2.8"/>
                    <measurement group_id="O3" value="6.1" spread="2.5"/>
                    <measurement group_id="O4" value="6.3" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 15: Freq of skipping meals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.9"/>
                    <measurement group_id="O2" value="2.8" spread="2.0"/>
                    <measurement group_id="O3" value="2.8" spread="1.7"/>
                    <measurement group_id="O4" value="2.9" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 16: Frequency of eating alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="2.8"/>
                    <measurement group_id="O2" value="5.0" spread="2.8"/>
                    <measurement group_id="O3" value="5.4" spread="2.7"/>
                    <measurement group_id="O4" value="5.4" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question #17: Freq of eating alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="2.5"/>
                    <measurement group_id="O2" value="6.2" spread="2.8"/>
                    <measurement group_id="O3" value="5.7" spread="2.5"/>
                    <measurement group_id="O4" value="5.9" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 18: Freq of eating while doing other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="2.4"/>
                    <measurement group_id="O2" value="5.8" spread="2.6"/>
                    <measurement group_id="O3" value="5.6" spread="2.2"/>
                    <measurement group_id="O4" value="6.0" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 19: Freq of eating more than intended</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="2.2"/>
                    <measurement group_id="O2" value="4.7" spread="2.5"/>
                    <measurement group_id="O3" value="4.7" spread="2.6"/>
                    <measurement group_id="O4" value="4.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 20: Freq of watching calories/portions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.6"/>
                    <measurement group_id="O2" value="5.6" spread="3.2"/>
                    <measurement group_id="O3" value="5.4" spread="2.7"/>
                    <measurement group_id="O4" value="5.6" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.</title>
        <description>Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.&#xD;
Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.</description>
        <time_frame>4 weeks</time_frame>
        <population>33 subjects completed the 4 week study.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
          <group group_id="O2">
            <title>100 Calorie Glucose Beverage</title>
            <description>Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week.</description>
          </group>
          <group group_id="O3">
            <title>50 cal Glucose Beverage</title>
            <description>Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
          <group group_id="O4">
            <title>10 cal Glucose Beverage</title>
            <description>Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.</title>
          <description>Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.&#xD;
Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.</description>
          <population>33 subjects completed the 4 week study.</population>
          <units>percentage of days in a week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" spread="14.2"/>
                    <measurement group_id="O2" value="16.0" spread="18.8"/>
                    <measurement group_id="O3" value="14.6" spread="20.0"/>
                    <measurement group_id="O4" value="14.1" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.</title>
        <description>Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.</description>
        <time_frame>4 weeks</time_frame>
        <population>33 subjects completed the 4 week study.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
          <group group_id="O2">
            <title>100 Calorie Glucose Beverage</title>
            <description>Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week.</description>
          </group>
          <group group_id="O3">
            <title>50 cal Glucose Beverage</title>
            <description>Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
          <group group_id="O4">
            <title>10 cal Glucose Beverage</title>
            <description>Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.&#xD;
Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.</title>
          <description>Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.</description>
          <population>33 subjects completed the 4 week study.</population>
          <units>percentage of days in a week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="23.6"/>
                    <measurement group_id="O2" value="44.1" spread="30.5"/>
                    <measurement group_id="O3" value="41.0" spread="28.0"/>
                    <measurement group_id="O4" value="43.3" spread="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected during the four-week study for each study participant.</time_frame>
      <desc>Adverse events were collected without regard for the intervention that was being administered.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Study Subjects</title>
          <description>Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>stomach ache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>upset stomach</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>bloating</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>jitteriness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flu</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study questionnaire involved limitations as questions were subjective in terms of how subjects defined cravings and snacking behavior. Also, food diaries may not be fully accurate accounts of subjects' actual caloric intake and food consumption.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. James Hill</name_or_title>
      <organization>University of Colorado, Anschutz Health and Wellness Center</organization>
      <phone>303-724-9974</phone>
      <email>james.hill@ucdenver.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02258477
org study id: 14-1485
nct id: NCT02258477
lead sponsor: 
collaborator: 
has dmc: No
To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a
      non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test
      whether there is a threshold of glucose that will result in improved ease of resistance to
      problem foods (tested by comparing three different levels of glucose).
Ingestion of 100 calories of glucose during individually pre-determined times of waning
      dietary self-control will result in improved ease of resistance to problem foods when
      compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)
allocation: Randomized
intervention model: Crossover Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Responses to the Control of Eating Questionnaire
time frame: 4 weeks
description: Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome.
Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).
measure: Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.
time frame: 4 weeks
description: Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.
Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
measure: Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.
time frame: 4 weeks
description: Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
arm group label: Sequence 1 (D-B-A-C)
arm group type: Active Comparator
description: 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
arm group label: Sequence 2 (A-D-C-B)
arm group type: Active Comparator
description: Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
arm group label: Sequence 3 (C-A-B-D)
arm group type: Active Comparator
description: 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
arm group label: Sequence 4 (B-C-D-A)
arm group type: Active Comparator
description: 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
intervention type: Dietary Supplement
intervention name: Sequence 1
description: 100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
arm group label: Sequence 1 (D-B-A-C)
intervention type: Dietary Supplement
intervention name: Sequence 2
description: Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
arm group label: Sequence 2 (A-D-C-B)
intervention type: Dietary Supplement
intervention name: Sequence 3
description: 50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
arm group label: Sequence 3 (C-A-B-D)
intervention type: Dietary Supplement
intervention name: Sequence 4
description: 10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
arm group label: Sequence 4 (B-C-D-A)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James O Hill, PhD
role: Principal Investigator
affiliation: Anschutz Health and Wellness Center
facility: 
country: United States
citation: Hand GA, Shook RP, Paluch AE, Baruth M, Crowley EP, Jaggers JR, Prasad VK, Hurley TG, Hebert JR, O'Connor DP, Archer E, Burgess S, Blair SN. The energy balance study: the design and baseline results for a longitudinal study of energy balance. Res Q Exerc Sport. 2013 Sep;84(3):275-86. doi: 10.1080/02701367.2013.816224.
PMID: 24261006
citation: Chang SH, Pollack LM, Colditz GA. Life Years Lost Associated with Obesity-Related Diseases for U.S. Non-Smoking Adults. PLoS One. 2013 Jun 18;8(6):e66550. doi: 10.1371/journal.pone.0066550. Print 2013.
PMID: 23823705
citation: Dulloo AG. Explaining the failures of obesity therapy: willpower attenuation, target miscalculation or metabolic compensation? Int J Obes (Lond). 2012 Nov;36(11):1418-20. doi: 10.1038/ijo.2012.114. No abstract available.
PMID: 23147189
citation: Masicampo EJ, Baumeister RF. Toward a physiology of dual-process reasoning and judgment: lemonade, willpower, and expensive rule-based analysis. Psychol Sci. 2008 Mar;19(3):255-60. doi: 10.1111/j.1467-9280.2008.02077.x.
PMID: 18315798
citation: Littell, Ramon C., George A. Milliken, Walter W. Stroup, Russell D. Wolfinger, and O Schabenberger. 2006. SAS@ for Mixed Models, Second Edition. Cary, NC: SAS Institute.
citation: Gailliot MT, Baumeister RF. The physiology of willpower: linking blood glucose to self-control. Pers Soc Psychol Rev. 2007 Nov;11(4):303-27. doi: 10.1177/1088868307303030.
PMID: 18453466
citation: Hofmann W, Adriaanse M, Vohs KD, Baumeister RF. Dieting and the self-control of eating in everyday environments: an experience sampling study. Br J Health Psychol. 2014 Sep;19(3):523-39. doi: 10.1111/bjhp.12053. Epub 2013 Jun 10.
PMID: 23751109
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study questionnaire involved limitations as questions were subjective in terms of how subjects defined cravings and snacking behavior. Also, food diaries may not be fully accurate accounts of subjects' actual caloric intake and food consumption.
point of contact: 