<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/NCT01677936</url>
  </required_header>
  <id_info>
    <org_study_id>Raisin DM 002</org_study_id>
    <nct_id>NCT01677936</nct_id>
  </id_info>
  <brief_title>Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Glycemic Control and Other Cardiovascular Risk Factors in Patients With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisville Metabolic and Atherosclerosis Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Raisin Marketing Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Louisville Metabolic and Atherosclerosis Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the effects of Raisins three times per day versus&#xD;
      alternative snacks three times per day on blood sugar control and cardiovascular risk factors&#xD;
      (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2&#xD;
      Diabetes Mellitus. These effects will be studied over a 12 week period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Raisins are often considered a good food choice because they provide dietary fiber and many&#xD;
      health-promoting nutrients, antioxidants and phytochemicals. Like most other fruits, raisins&#xD;
      are devoid of fat, saturated fat and cholesterol, and low in sodium; these features, combined&#xD;
      with their high potassium content, high fiber, and low glycemic index make them potentially&#xD;
      preferable to other foods in their effects upon glycemic control and cardiovascular risk&#xD;
      factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial Glucose Levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Raisins versus snacks: percent change in postprandial glucose levels at week 12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>12 weeks.</time_frame>
    <description>Raisins versus snacks: mmHg change in systolic blood pressure at week 12</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Raisin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Snack Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Raisins</intervention_name>
    <description>1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm</description>
    <arm_group_label>Raisin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Snacks</intervention_name>
    <description>100 calorie snack packs will be administered to the subjects in the snack group</description>
    <arm_group_label>Snack Group</arm_group_label>
    <other_name>100 calorie snack packs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are generally healthy men and women older than 18 years of age&#xD;
&#xD;
          -  Are willing and able to undergo an informed consent process&#xD;
&#xD;
          -  Have medical history of Type 2 Diabetes Mellitus&#xD;
&#xD;
          -  Have hemoglobin A1c 67.5 - 10%&#xD;
&#xD;
          -  Have body mass index (BMI) 25.0 to 39.9 kg/m2&#xD;
&#xD;
          -  Have blood pressure &gt; 100 mmHg systolic or &gt; 70 mmHg diastolic&#xD;
&#xD;
          -  Are willing and able to perform self-glucose monitoring throughout the study&#xD;
&#xD;
          -  Are willing to fast before study visits&#xD;
&#xD;
          -  Are willing and able to bring in their morning anti-diabetes mellitus drugs to study&#xD;
             visits&#xD;
&#xD;
          -  Women must be of non-childbearing potential defined as postmenopausal for at least 2&#xD;
             years or surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or&#xD;
             hysterectomy).&#xD;
&#xD;
          -  If not menopausal or surgically sterile, then women of child-bearing potential must be&#xD;
             willing to use:&#xD;
&#xD;
               -  oral contraceptives and another acceptable form of birth control, or&#xD;
&#xD;
               -  double barrier birth control methods such as condom or occlusive cap (e.g.&#xD;
                  diaphragm or cervical/vault caps) plus spermicidal agent (e.g. foam, gel, film,&#xD;
                  cream, suppository).&#xD;
&#xD;
          -  Are willing to notify the research staff of any change in their medical health &amp;&#xD;
             concomitant medications/supplements during the course of the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance, dislike, or unwillingness to consume raisins or any of the comparator&#xD;
             snacks and affiliated ingredients&#xD;
&#xD;
          -  History of greater than one drug allergy&#xD;
&#xD;
          -  History of greater than one &quot;food allergy&quot;&#xD;
&#xD;
          -  Change in anti-diabetes mellitus medication within 3 months prior to screening visit&#xD;
&#xD;
          -  Change in blood pressure and/or lipid-altering medications within 1 month of screening&#xD;
             visit&#xD;
&#xD;
          -  Plans to change current anti-diabetes mellitus, blood pressure, or lipid-altering&#xD;
             medications during course of the study&#xD;
&#xD;
          -  Unwilling to maintain current anti-diabetes mellitus, blood pressure, or&#xD;
             lipid-altering medications and their doses during the course of the study&#xD;
&#xD;
          -  History of clinically significant diabetes mellitus complications, that in the opinion&#xD;
             of the investigator, may interfere with the successful completion of the trial&#xD;
&#xD;
          -  History of clinically significant diabetes mellitus kidney disease (e.g. clinically&#xD;
             significant proteinuria)&#xD;
&#xD;
          -  History of severe high or low blood sugars within the past year, as per Investigator&#xD;
             discretion&#xD;
&#xD;
          -  History of severe high or low blood sugars requiring hospitalization at any time in&#xD;
             the past&#xD;
&#xD;
          -  Subjects are excluded if within the past 6 months, they have history of myocardial&#xD;
             infarction, acute coronary syndrome, stroke, or any cardiac / vascular surgical&#xD;
             procedure (e.g. atherosclerotic coronary heart disease by-pass, carotid surgery,&#xD;
             peripheral vascular by-pass, stent placement, pacemaker placement, etc.), unstable&#xD;
             angina, or alterations in treatment of stable angina&#xD;
&#xD;
          -  Subjects are excluded if at any time in the past, they have history of clinically&#xD;
             significant ventricular or atrial dysrhythmias&#xD;
&#xD;
          -  Subjects are excluded if at any time in the past, they have history of New York Heart&#xD;
             Association (NYHA) functional heart failure of Class III or greater, defined as: CLASS&#xD;
             III: Marked limitation of physical activity, comfortable at rest, but less than&#xD;
             ordinary activity causes fatigue, palpitations or dyspnea, CLASS IV: Unable to carry&#xD;
             out any physical activity without discomfort, symptoms of cardiac insufficiency at&#xD;
             rest, if any physical activity is undertaken, discomfort is increased&#xD;
&#xD;
          -  Subjects are excluded if at any time in the past, they have history of or known&#xD;
             increases in QTc&#xD;
&#xD;
          -  History of seizures in the past year&#xD;
&#xD;
          -  Is pregnant, breastfeeding or plans to become pregnant during the course of the&#xD;
             clinical trial&#xD;
&#xD;
          -  Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the&#xD;
             informed consent document), or current plans to have a major surgical procedure during&#xD;
             study participation or 30 days following completion of all study related procedures&#xD;
&#xD;
          -  History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or&#xD;
             history of a gastric bypass or other diversional bariatric surgery. Gastric banding&#xD;
             procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day&#xD;
             of signing the informed consent document), or a reasonable chance of having a gastric&#xD;
             banding adjustment during the course of the study&#xD;
&#xD;
          -  History of ongoing malignancy. History of malignancy is acceptable for eligibility if&#xD;
             successfully treated, with no evidence of persistence or recurrence of the malignancy&#xD;
             within 5 years of visit #1 (i.e. day of signing the informed consent document) or&#xD;
             basal carcinoma of the skin and &quot;in situ&quot; cancer of the cervix successfully treated 30&#xD;
             days prior to visit #1&#xD;
&#xD;
          -  History of organ transplant.&#xD;
&#xD;
          -  History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit&#xD;
             #1 (i.e. day of signing the informed consent document)&#xD;
&#xD;
          -  Routinely consumes more than 2 units of alcohol per day. A unit of alcohol is defined&#xD;
             as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof&#xD;
             alcohol for mixed drinks.&#xD;
&#xD;
          -  History of clinically significant heart, vascular, hematologic, orthopedic,&#xD;
             rheumatologic, muscle, brain, neurologic (e.g. dementia, uncontrolled seizure&#xD;
             disorder, etc.) , gastrointestinal (such as chronic hepatitis B or C, malabsorptive&#xD;
             intestinal diseases such as uncontrolled crohn's disease, ulcerative colitis, severe&#xD;
             irritable bowel syndrome, other significant gastrointestinal diseases that may&#xD;
             interfere with study participation and/or results), endocrine (uncontrolled hyper or&#xD;
             hypothyroidism), ophthalmologic, infectious (e.g. human immunodeficiency virus,&#xD;
             tuberculosis, etc.) immunologic, nephrologic, pulmonary (e.g. poorly controlled&#xD;
             asthma, poorly controlled chronic obstructive pulmonary disease, dyspnea, etc.),&#xD;
             dermatologic, reproductive, psychiatric (e.g. bipolar disorder, schizophrenia,&#xD;
             borderline personality disorder, etc.) disorders, or any other conditions that would&#xD;
             present unacceptable risk to study subjects, compromise the acquisition or&#xD;
             interpretation of study data, or otherwise interfere with the study subject's&#xD;
             participation in the study.&#xD;
&#xD;
          -  History of severe or uncontrolled depression based upon the opinion of the Principal&#xD;
             Investigator.&#xD;
&#xD;
          -  Blood pressure &gt;160 mmHg systolic or &gt;100 mmHg diastolic.&#xD;
&#xD;
          -  Weight change (increase or decrease) of &gt; 5 pounds in 2 months (by history) prior to&#xD;
             visit 1&#xD;
&#xD;
          -  Bradycardia defined as pulse less than 50 beats/minute&#xD;
&#xD;
          -  History of clinically significant anemia&#xD;
&#xD;
          -  Fasting serum lipoprotein values of: LDL-cholesterol, &gt;160 mg/dl or triglycerides,&#xD;
             &gt;500 mg/dl (exclusionary during screening only)&#xD;
&#xD;
          -  Creatinine level on screening &gt; 1.5 times the upper range of normal.&#xD;
&#xD;
          -  Liver enzymes on screening &gt; 2 times the upper limits of normal&#xD;
&#xD;
          -  Potassium level above the upper range of normal upon screening (one repeat lab would&#xD;
             be permitted if the initial elevated potassium level is thought possibly due to&#xD;
             laboratory error)&#xD;
&#xD;
          -  Known laboratory abnormalities prior to randomization which Principal Investigator&#xD;
             deems may pose an unacceptable risk, compromise acquisition or interpretation of study&#xD;
             data, or otherwise interfere with the study subject's participation in the study&#xD;
&#xD;
          -  Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active&#xD;
             hepatitis A immunoglobulin M, or human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Current or past use of insulin&#xD;
&#xD;
          -  Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled&#xD;
             and intranasal corticosteroids are permitted.&#xD;
&#xD;
          -  Use of antiobesity/weight maintenance drug therapies at initial study visit, or within&#xD;
             2 months of the initial study visit.&#xD;
&#xD;
          -  Use of digoxin or other cardiac antidysrhythmic drugs&#xD;
&#xD;
          -  Use of anticoagulants (such as warfarin, Coumadin)&#xD;
&#xD;
          -  Use of dietary supplements are acceptable, as long as the supplement intake was&#xD;
             constant for one month prior to visit 1, and the study participant plans to continue&#xD;
             the same supplement at the same dose throughout the study&#xD;
&#xD;
          -  Known medical history of clinical significance, or any other conditions that would&#xD;
             present unacceptable risk to study subject, compromise the acquisition or&#xD;
             interpretation of study data, or otherwise interfere with the study subject's&#xD;
             participation in the study as per discretion of the Principal Investigator.&#xD;
&#xD;
          -  Is an employee or immediate family member of the research staff.&#xD;
&#xD;
          -  Donated blood within 2 months prior to study entry, or plans to donate blood during&#xD;
             the course of this study.&#xD;
&#xD;
          -  Anticipation of a significant change in job, job duties, or job work hours, which&#xD;
             might impair their ability and willingness to undergo study-related procedures under&#xD;
             the timelines specified by protocol, and otherwise impede their completion of the&#xD;
             study.&#xD;
&#xD;
          -  Anticipation of or a reasonable likelihood of moving away from the research site,&#xD;
             wherein such a move might impair their ability and willingness to undergo&#xD;
             study-related procedures within the timelines specified by protocol, or otherwise&#xD;
             impede their completion of the study.&#xD;
&#xD;
          -  Anticipation of or a reasonable likelihood of vacations or other times away from home&#xD;
             which might impair their ability and willingness to undergo study-related procedures&#xD;
             within the timelines specified by the study protocol, or otherwise impede their&#xD;
             completion of the study.&#xD;
&#xD;
          -  Planned or anticipated major changes in lifestyle health practices, except as allowed&#xD;
             by study protocol.&#xD;
&#xD;
          -  Treatment with an investigational product or an investigational device within 30 days&#xD;
             prior to visit #1 (i.e. day of signing the informed consent document) and have no&#xD;
             plans to potentially start any investigational product or use an investigational&#xD;
             device during or 30 days after the study subject completes all study related&#xD;
             procedures.&#xD;
&#xD;
          -  Reasonable life-expectancy of less than 2 years.&#xD;
&#xD;
          -  Any other reason, if in the opinion of the Investigator, the individual study subject&#xD;
             is not appropriate, or suitable for participation in the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harold E Bays, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>L-MARC Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>L-MARC Research Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>February 2, 2014</results_first_submitted>
  <results_first_submitted_qc>March 22, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 23, 2014</results_first_posted>
  <last_update_submitted>March 22, 2014</last_update_submitted>
  <last_update_submitted_qc>March 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>blood pressure</keyword>
  <keyword>lipid</keyword>
  <keyword>waist circumference</keyword>
  <keyword>BMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>51 total subjects were randomized. 5 were excluded (1 snack; 4 raisin) due to lack of post-randomization evaluable data. Thus, the full analysis data set included 27 raisin and 19 snack.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Raisin</title>
          <description>Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.&#xD;
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm</description>
        </group>
        <group group_id="P2">
          <title>Snack Group</title>
          <description>Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.&#xD;
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31">31 randomized to raisins; 4 excluded due to lack of post-baseline evaluation; 27 = full dataset</participants>
                <participants group_id="P2" count="20">20 randomized to snacks; 1 excluded due to lack of post-baseline evaluation; 19 = full dataset</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22">Full analysis dataset completers</participants>
                <participants group_id="P2" count="15">Full analysis dataset completers</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>51 total subjects were randomized. 5 were excluded (1 snack; 4 raisin) due to lack of post-randomization evaluable data. Thus, the full analysis data set included 27 raisin and 19 snack.</population>
      <group_list>
        <group group_id="B1">
          <title>Raisin</title>
          <description>Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.&#xD;
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm</description>
        </group>
        <group group_id="B2">
          <title>Snack Group</title>
          <description>Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.&#xD;
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="8.56"/>
                    <measurement group_id="B2" value="59" spread="12.54"/>
                    <measurement group_id="B3" value="58" spread="10.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </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="27"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postprandial Glucose Levels</title>
        <description>Raisins versus snacks: percent change in postprandial glucose levels at week 12</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raisin</title>
            <description>Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.&#xD;
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm</description>
          </group>
          <group group_id="O2">
            <title>Snack Group</title>
            <description>Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.&#xD;
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group</description>
          </group>
        </group_list>
        <measure>
          <title>Postprandial Glucose Levels</title>
          <description>Raisins versus snacks: percent change in postprandial glucose levels at week 12</description>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6" spread="24"/>
                    <measurement group_id="O2" value="17" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.024</p_value>
            <p_value_desc>Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>23</param_value>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure</title>
        <description>Raisins versus snacks: mmHg change in systolic blood pressure at week 12</description>
        <time_frame>12 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Raisin</title>
            <description>Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.&#xD;
Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm</description>
          </group>
          <group group_id="O2">
            <title>Snack Group</title>
            <description>Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.&#xD;
Snacks: 100 calorie snack packs will be administered to the subjects in the snack group</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Raisins versus snacks: mmHg change in systolic blood pressure at week 12</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="13"/>
                    <measurement group_id="O2" value="4.5" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.035</p_value>
            <p_value_desc>Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.7</param_value>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Raisin</title>
          <description>Raisin group</description>
        </group>
        <group group_id="E2">
          <title>Snacks</title>
          <description>Snack group</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="1" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolus</sub_title>
                <description>Regarding safety, only one Serious Adverse Experience occurred in a raisin administered subject who experienced a pulmonary embolus after a surgical procedure of hip replacement.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="8" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal complaints</sub_title>
                <description>Gastrointestinal complaints</description>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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>This study was limited by being an un-blinded, single site study of modest size.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kathy Schmitz RN</name_or_title>
      <organization>Louisville Metabolic and Atherosclerosis Research Center</organization>
      <phone>502.515.5672</phone>
      <email>kschmitz@lmarc.com</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/NCT01677936
org study id: Raisin DM 002
nct id: NCT01677936
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to compare the effects of Raisins three times per day versus
      alternative snacks three times per day on blood sugar control and cardiovascular risk factors
      (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2
      Diabetes Mellitus. These effects will be studied over a 12 week period.
Raisins are often considered a good food choice because they provide dietary fiber and many
      health-promoting nutrients, antioxidants and phytochemicals. Like most other fruits, raisins
      are devoid of fat, saturated fat and cholesterol, and low in sodium; these features, combined
      with their high potassium content, high fiber, and low glycemic index make them potentially
      preferable to other foods in their effects upon glycemic control and cardiovascular risk
      factors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postprandial Glucose Levels
time frame: 12 weeks
description: Raisins versus snacks: percent change in postprandial glucose levels at week 12
measure: Systolic Blood Pressure
time frame: 12 weeks.
description: Raisins versus snacks: mmHg change in systolic blood pressure at week 12
arm group label: Raisin
arm group type: Experimental
description: Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.
arm group label: Snack Group
arm group type: Active Comparator
description: Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.
intervention type: Other
intervention name: Raisins
description: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm
arm group label: Raisin
intervention type: Other
intervention name: Snacks
description: 100 calorie snack packs will be administered to the subjects in the snack group
arm group label: Snack Group
other name: 100 calorie snack packs
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harold E Bays, MD
role: Principal Investigator
affiliation: L-MARC Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was limited by being an un-blinded, single site study of modest size.
point of contact: 