<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/NCT01690936</url>
  </required_header>
  <id_info>
    <org_study_id>055-022</org_study_id>
    <secondary_id>Snacking study</secondary_id>
    <nct_id>NCT01690936</nct_id>
  </id_info>
  <brief_title>Metabolic Effects of Almond in the Longer-term Study</brief_title>
  <acronym>MEAL</acronym>
  <official_title>Effects of Chronic Almond Consumption at Meals or as Snacks on Appetite, Intake, Body Weight, Glycemia, Insulinemia and Lipids in Healthy Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Almond Board of California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Identifying snacks that do not contribute to positive energy balance is crucial in weight&#xD;
      management. The satiating effects of almonds, coupled with their convenience and palatability&#xD;
      make them a promising weight management aid. Therefore, this study aimed to examine the&#xD;
      effects of almond consumption with meals versus snacks on outcomes such as appetite, energy&#xD;
      intake, body weight, as well as blood glucose, insulin and lipid responses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experiment protocol and measurements&#xD;
&#xD;
      i) Oral glucose tolerance test (OGTT) sessions&#xD;
&#xD;
      At baseline, participants attended a session where a standard OGTT with drinks containing 75&#xD;
      grams dextrose was performed following an overnight fasting. Serum glucose and insulin&#xD;
      concentrations were measured at 0 and 120 minutes of the session. During the same session,&#xD;
      height, weight (Tanita), body fat (air displacement plethysmography, BOD POD), waist&#xD;
      circumference, and blood pressure were measured. Participants also completed a 24-hour&#xD;
      dietary recall using a multi-pass interview method and standard questionnaires that assessed&#xD;
      personality, eating behavior and habitual physical activity levels during the OGTT session.&#xD;
      After the completion of this session, participants were asked to record their hourly appetite&#xD;
      sensations, measured as &quot;hunger&quot;, &quot;fullness&quot; and &quot;desire to eat&quot; on visual analog scales,&#xD;
      during waking hours for a day before attending the next (clinical) visit. Participants&#xD;
      repeated this session after four weeks of almond consumption.&#xD;
&#xD;
      ii) Acute feeding sessions&#xD;
&#xD;
      Within a week following the OGTT session, participants returned for an acute-feeding session,&#xD;
      after an overnight fasting of at least 10 hours. This session began between 7:00 am and 8:00&#xD;
      am, and lasted for approximately 515 minutes. Upon arrival, an indwelling arm catheter was&#xD;
      placed in the upper arm for blood sample collection. Participants rested for 15 minutes after&#xD;
      catheter placement, before a baseline blood sample was drawn. Immediately after the first&#xD;
      blood sample collection, a standard breakfast was served, and participants were instructed to&#xD;
      consume the entire portion within 10 minutes. Subsequent blood samplings were performed at&#xD;
      15, 45, 60, 90, 120, 180, and 240 minutes after the breakfast, before a standard lunch was&#xD;
      provided to the participants. Again, participants were given 10 minutes to consume the lunch,&#xD;
      before blood samples were taken at similar intervals again (at 265, 295, 310, 340, 370, 430,&#xD;
      and 490 minutes of the session). Participants randomized into the BF and LN groups received&#xD;
      43 grams of almonds together with their meals, while the MS and AS groups consumed 43 grams&#xD;
      of almonds 120 minutes after breakfast and lunch respectively. Participants also recorded&#xD;
      their &quot;hunger&quot;, &quot;fullness&quot;, and &quot;desire to eat&quot; sensations when blood samples were taken.&#xD;
      During the acute-feeding session, activities that may alter appetite sensations (e.g.&#xD;
      sleeping and watching movies containing food cues) were prohibited. Postprandial glucose,&#xD;
      insulin and triacylglycerol concentrations were measured for all 15 samples collected from&#xD;
      each participant. Participants in all almond groups group were also asked to rate their&#xD;
      likings for the almonds they ingested using a general label magnitude scale, and their action&#xD;
      responses to almonds using the &quot;food action rating scale&quot;, a visual analog scale ranging from&#xD;
      &quot;I would eat the almonds only if I were forced to&quot; to &quot;I would eat this food every&#xD;
      opportunity I had&quot; anchored to the 2 extremes. This session was repeated again after four&#xD;
      weeks of almond supplementation.&#xD;
&#xD;
      iii) Weekly follow-ups&#xD;
&#xD;
      Following the baseline acute-feeding session, participants were asked to consume 43 grams of&#xD;
      almonds every day at times based on their group randomization. The CL group was instructed to&#xD;
      avoid all nuts and seeds in the diet during the study period. All almonds were dry-roasted&#xD;
      and lightly salted, and were pre-weighed and per-packaged for convenience. Except for the&#xD;
      permission to adjust dietary intake due to almond supplement, participants were asked to&#xD;
      maintain their dietary intakes and physical activity levels. A ruse (breath analysis) was&#xD;
      introduced in order to enhance the compliance of participants to consuming almonds at the&#xD;
      designated times of day. Compliance to almond consumption was assessed through fasting plasma&#xD;
      α-tocopherol. Participants attended weekly visit (week-1, 2 and 3) after an overnight&#xD;
      fasting, during which body weight was recorded and compliance to study protocol reinforced.&#xD;
      During the week-2 visit, participants were also asked to complete a 24-hour dietary intake&#xD;
      assessment using the multi-pass interview method and appetite sensation ratings on VAS at&#xD;
      every waking hour for a day. On week-4, participants returned for OGTT and acute-feeding&#xD;
      sessions as described above. The study protocol was approved by the Purdue University&#xD;
      Institutional Review Board.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial glucose, insulin and lipids</measure>
    <time_frame>490 minutes</time_frame>
    <description>Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes in body weight, BMI, fat mass, waist circumference over 4 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting blood biochemistries</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>4 weeks</time_frame>
    <description>Dietary intakes were assessed at baseline, week-2, and week-4 of study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline and week-4</time_frame>
    <description>Blood pressure measurements at baseline and final week of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite ratings</measure>
    <time_frame>Baseline, week-2, and week-4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial appetite sensations</measure>
    <time_frame>490 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Breakfast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Almonds (43g/day) were consumed with breakfast for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morning snack</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Almonds (43g/day) were consumed alone as morning snacks for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lunch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Almonds (43g/day) were consumed with lunch for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Afternoon snack</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control no nuts</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Avoided all nuts and seeds</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Almonds 43g/day</intervention_name>
    <description>43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period</description>
    <arm_group_label>Afternoon snack</arm_group_label>
    <arm_group_label>Breakfast</arm_group_label>
    <arm_group_label>Lunch</arm_group_label>
    <arm_group_label>Morning snack</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not taking any medication known to affect glycemia, lipid metabolism or appetite&#xD;
&#xD;
          -  Regular breakfast consumers&#xD;
&#xD;
          -  Eat at least 5 meals a day&#xD;
&#xD;
          -  Weight stable&#xD;
&#xD;
          -  Either one of the 6 conditions&#xD;
&#xD;
          -  BMI 27-35&#xD;
&#xD;
          -  Family history of diabetes&#xD;
&#xD;
          -  Fasting glucose between 6.1-6.9 mmol/L&#xD;
&#xD;
          -  2-hour glucose 7.8-11.1 mmol/L&#xD;
&#xD;
          -  blood pressure &gt;130/85 mmHg&#xD;
&#xD;
          -  Waist &gt;102cm (men) and &gt;88cm (women)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nut allergy&#xD;
&#xD;
          -  Not willing to eat test foods and almonds&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard D Mattes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Purdue University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>May 28, 2013</last_update_submitted>
  <last_update_submitted_qc>May 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Richard Mattes</investigator_full_name>
    <investigator_title>Distinguished Prof Foods and Nutrition</investigator_title>
  </responsible_party>
  <keyword>Almonds</keyword>
  <keyword>Body weight</keyword>
  <keyword>Snacking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01690936
org study id: 055-022
secondary id: Snacking study
nct id: NCT01690936
lead sponsor: 
collaborator: 
has dmc: Yes
Identifying snacks that do not contribute to positive energy balance is crucial in weight
      management. The satiating effects of almonds, coupled with their convenience and palatability
      make them a promising weight management aid. Therefore, this study aimed to examine the
      effects of almond consumption with meals versus snacks on outcomes such as appetite, energy
      intake, body weight, as well as blood glucose, insulin and lipid responses.
Experiment protocol and measurements

      i) Oral glucose tolerance test (OGTT) sessions

      At baseline, participants attended a session where a standard OGTT with drinks containing 75
      grams dextrose was performed following an overnight fasting. Serum glucose and insulin
      concentrations were measured at 0 and 120 minutes of the session. During the same session,
      height, weight (Tanita), body fat (air displacement plethysmography, BOD POD), waist
      circumference, and blood pressure were measured. Participants also completed a 24-hour
      dietary recall using a multi-pass interview method and standard questionnaires that assessed
      personality, eating behavior and habitual physical activity levels during the OGTT session.
      After the completion of this session, participants were asked to record their hourly appetite
      sensations, measured as "hunger", "fullness" and "desire to eat" on visual analog scales,
      during waking hours for a day before attending the next (clinical) visit. Participants
      repeated this session after four weeks of almond consumption.

      ii) Acute feeding sessions

      Within a week following the OGTT session, participants returned for an acute-feeding session,
      after an overnight fasting of at least 10 hours. This session began between 7:00 am and 8:00
      am, and lasted for approximately 515 minutes. Upon arrival, an indwelling arm catheter was
      placed in the upper arm for blood sample collection. Participants rested for 15 minutes after
      catheter placement, before a baseline blood sample was drawn. Immediately after the first
      blood sample collection, a standard breakfast was served, and participants were instructed to
      consume the entire portion within 10 minutes. Subsequent blood samplings were performed at
      15, 45, 60, 90, 120, 180, and 240 minutes after the breakfast, before a standard lunch was
      provided to the participants. Again, participants were given 10 minutes to consume the lunch,
      before blood samples were taken at similar intervals again (at 265, 295, 310, 340, 370, 430,
      and 490 minutes of the session). Participants randomized into the BF and LN groups received
      43 grams of almonds together with their meals, while the MS and AS groups consumed 43 grams
      of almonds 120 minutes after breakfast and lunch respectively. Participants also recorded
      their "hunger", "fullness", and "desire to eat" sensations when blood samples were taken.
      During the acute-feeding session, activities that may alter appetite sensations (e.g.
      sleeping and watching movies containing food cues) were prohibited. Postprandial glucose,
      insulin and triacylglycerol concentrations were measured for all 15 samples collected from
      each participant. Participants in all almond groups group were also asked to rate their
      likings for the almonds they ingested using a general label magnitude scale, and their action
      responses to almonds using the "food action rating scale", a visual analog scale ranging from
      "I would eat the almonds only if I were forced to" to "I would eat this food every
      opportunity I had" anchored to the 2 extremes. This session was repeated again after four
      weeks of almond supplementation.

      iii) Weekly follow-ups

      Following the baseline acute-feeding session, participants were asked to consume 43 grams of
      almonds every day at times based on their group randomization. The CL group was instructed to
      avoid all nuts and seeds in the diet during the study period. All almonds were dry-roasted
      and lightly salted, and were pre-weighed and per-packaged for convenience. Except for the
      permission to adjust dietary intake due to almond supplement, participants were asked to
      maintain their dietary intakes and physical activity levels. A ruse (breath analysis) was
      introduced in order to enhance the compliance of participants to consuming almonds at the
      designated times of day. Compliance to almond consumption was assessed through fasting plasma
      α-tocopherol. Participants attended weekly visit (week-1, 2 and 3) after an overnight
      fasting, during which body weight was recorded and compliance to study protocol reinforced.
      During the week-2 visit, participants were also asked to complete a 24-hour dietary intake
      assessment using the multi-pass interview method and appetite sensation ratings on VAS at
      every waking hour for a day. On week-4, participants returned for OGTT and acute-feeding
      sessions as described above. The study protocol was approved by the Purdue University
      Institutional Review Board.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Postprandial glucose, insulin and lipids
time frame: 490 minutes
description: Responses of these parameters to a standard breakfast and a standard lunch for all participants, plus almonds at designated times according to group randomization.
measure: Anthropometric measurements
time frame: 4 weeks
description: Changes in body weight, BMI, fat mass, waist circumference over 4 weeks
measure: Fasting blood biochemistries
time frame: 4 weeks
description: Fasting glucose, insulin and lipids at baseline, week-1, 2, 3 and 4
measure: Dietary intake
time frame: 4 weeks
description: Dietary intakes were assessed at baseline, week-2, and week-4 of study
measure: Blood pressure
time frame: Baseline and week-4
description: Blood pressure measurements at baseline and final week of study
measure: Appetite ratings
time frame: Baseline, week-2, and week-4
measure: Postprandial appetite sensations
time frame: 490 minutes
arm group label: Breakfast
arm group type: Experimental
description: Almonds (43g/day) were consumed with breakfast for four weeks.
arm group label: Morning snack
arm group type: Experimental
description: Almonds (43g/day) were consumed alone as morning snacks for four weeks.
arm group label: Lunch
arm group type: Experimental
description: Almonds (43g/day) were consumed with lunch for four weeks.
arm group label: Afternoon snack
arm group type: Experimental
description: Almonds (43g/day) were consumed alone as afternoon snacks for four weeks.
arm group label: Control no nuts
arm group type: No Intervention
description: Avoided all nuts and seeds
intervention type: Dietary Supplement
intervention name: Almonds 43g/day
description: 43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
arm group label: Afternoon snack
arm group label: Breakfast
arm group label: Lunch
arm group label: Morning snack
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard D Mattes, PhD
role: Principal Investigator
affiliation: Purdue University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Richard Mattes
investigator title: Distinguished Prof Foods and Nutrition
mesh term: Body Weight