<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/NCT03236116</url>
  </required_header>
  <id_info>
    <org_study_id>055-047</org_study_id>
    <nct_id>NCT03236116</nct_id>
  </id_info>
  <brief_title>Almond Consumption and Glycemia</brief_title>
  <official_title>Almond Consumption and Glycemia</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effects of almonds consumed by adults with different body fat&#xD;
      distributions on indices of carbohydrate and lipid metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is considerable evidence supporting a causal role for truncal visceral fat depots in&#xD;
      glucose dysregulation. Individuals with large visceral fat depots have impaired suppression&#xD;
      of free fatty acid release in response to insulin, elevated triglycerides and low&#xD;
      concentrations of high density lipoprotein cholesterol. The high free fatty acid&#xD;
      concentration may induce insulin resistance in the muscle and liver. There is more recent&#xD;
      evidence that truncal subcutaneous fat depots are also problematic, though this literature is&#xD;
      mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance&#xD;
      and dysregulation of carbohydrate metabolism. Failure to account for differences in the&#xD;
      contributions of these depots will add noise to measurements of dietary interventions to&#xD;
      mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and&#xD;
      chronic consumption of almonds improves glycemia. Acute effects are important indicators of&#xD;
      health benefit, but longer-term trials, ones permitting identification of the effects of a&#xD;
      dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively&#xD;
      establish the association between almond consumption and improved carbohydrate metabolism, we&#xD;
      propose a six-month trial that contrasts the effects of almond consumption at optimal times&#xD;
      of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate&#xD;
      metabolism, food intake and appetite in adults characterized by three distinct fat depots.&#xD;
&#xD;
      Participants will consume either almonds, or no nuts every day for 6 months. At baseline,&#xD;
      participants will be weighed and undergo a DEXA scan to determine body fat composition and&#xD;
      will be assigned a group. Blood will also be collected fasted and at stipulated times in&#xD;
      response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel,&#xD;
      gut peptides, and compliance to the diet. Participants will be given links to complete&#xD;
      appetite ratings and record food intake. Participants will report to the lab every two weeks&#xD;
      to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark&#xD;
      on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to&#xD;
      the diet, and links will be given to complete appetite ratings and record food intake. At&#xD;
      month 6, all measurements from baseline will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Baseline</time_frame>
    <description>HbA1c.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fasting glucose</measure>
    <time_frame>Baseline</time_frame>
    <description>fasting glucose,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fasting triglycerides</measure>
    <time_frame>Baseline</time_frame>
    <description>fasting triglycerides</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body weight</measure>
    <time_frame>Every two weeks for 6 months.</time_frame>
    <description>Body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body composition</measure>
    <time_frame>Baseline</time_frame>
    <description>Body composition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GLP-1</measure>
    <time_frame>Baseline</time_frame>
    <description>GLP-1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>HbA1c.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasting glucose</measure>
    <time_frame>6 months</time_frame>
    <description>fasting glucose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fasting triglycerides</measure>
    <time_frame>6 months</time_frame>
    <description>fasting triglycerides</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body composition</measure>
    <time_frame>6 months</time_frame>
    <description>Body composition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in GLP-1</measure>
    <time_frame>6 months</time_frame>
    <description>GLP-1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fasting insulin</measure>
    <time_frame>Baseline</time_frame>
    <description>fasting insulin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>total cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>LDL-cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>Baseline</time_frame>
    <description>HDL-cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GIP</measure>
    <time_frame>Baseline</time_frame>
    <description>GIP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in fasting insulin</measure>
    <time_frame>6 months</time_frame>
    <description>fasting insulin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in total cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>total cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in LDL-cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>LDL-cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in HDL-cholesterol</measure>
    <time_frame>6 months</time_frame>
    <description>HDL-cholesterol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in GIP</measure>
    <time_frame>6 months</time_frame>
    <description>GIP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-peptide</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C-peptide</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Homa-IR</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Homa-IR</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Homa-Percent Beta</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Homa-Percent Beta</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet Quality</measure>
    <time_frame>Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.</time_frame>
    <description>Determine the effect of substituting a wholesome snack food (almonds) for more traditional, less nutrient dense, snack foods on total diet quality. Food intake will be measured by the ASA-24 for three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>Baseline, month 2, 4, and 6.</time_frame>
    <description>Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Glucose Intolerance</condition>
  <condition>Appetite Disorders</condition>
  <condition>Glucose Metabolism Disorders (Including Diabetes Mellitus)</condition>
  <condition>Lipid Metabolism Disorder</condition>
  <arm_group>
    <arm_group_label>Almond Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Almonds</intervention_name>
    <description>Participants will consume almonds everyday for 6 months.</description>
    <arm_group_label>Almond Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control (no nuts)</intervention_name>
    <description>Participants will not be permited to consume any nuts for 6 months.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meeting one of the following body fat distribution criteria determined by DEXA: 1.&#xD;
             High visceral fat 2. High gluteo-femoral fat 3. High truncal subcutaneous fat&#xD;
&#xD;
          -  18-60 years&#xD;
&#xD;
          -  no nut allergies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting one of the body fat distribution criteria&#xD;
&#xD;
          -  allergic to nuts&#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>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</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>Professor, Nutrition Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03236116
org study id: 055-047
nct id: NCT03236116
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the effects of almonds consumed by adults with different body fat
      distributions on indices of carbohydrate and lipid metabolism.
There is considerable evidence supporting a causal role for truncal visceral fat depots in
      glucose dysregulation. Individuals with large visceral fat depots have impaired suppression
      of free fatty acid release in response to insulin, elevated triglycerides and low
      concentrations of high density lipoprotein cholesterol. The high free fatty acid
      concentration may induce insulin resistance in the muscle and liver. There is more recent
      evidence that truncal subcutaneous fat depots are also problematic, though this literature is
      mixed. In contrast, gluteo-femoral fat depots have not been implicated in insulin resistance
      and dysregulation of carbohydrate metabolism. Failure to account for differences in the
      contributions of these depots will add noise to measurements of dietary interventions to
      mitigate glucose dysregulation. Previous studies have reported evidence indicating acute and
      chronic consumption of almonds improves glycemia. Acute effects are important indicators of
      health benefit, but longer-term trials, ones permitting identification of the effects of a
      dietary intervention on HbA1c, are more telling and clinically relevant. To more definitively
      establish the association between almond consumption and improved carbohydrate metabolism, we
      propose a six-month trial that contrasts the effects of almond consumption at optimal times
      of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate
      metabolism, food intake and appetite in adults characterized by three distinct fat depots.

      Participants will consume either almonds, or no nuts every day for 6 months. At baseline,
      participants will be weighed and undergo a DEXA scan to determine body fat composition and
      will be assigned a group. Blood will also be collected fasted and at stipulated times in
      response to a meal tolerance test to measure insulin, glucose, C-peptide, HbA1c, lipid panel,
      gut peptides, and compliance to the diet. Participants will be given links to complete
      appetite ratings and record food intake. Participants will report to the lab every two weeks
      to be weighed, and get a resupply of almonds (if in the almond group). At the two-week mark
      on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to
      the diet, and links will be given to complete appetite ratings and record food intake. At
      month 6, all measurements from baseline will be repeated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: HbA1c
time frame: Baseline
description: HbA1c.
measure: fasting glucose
time frame: Baseline
description: fasting glucose,
measure: fasting triglycerides
time frame: Baseline
description: fasting triglycerides
measure: Change in Body weight
time frame: Every two weeks for 6 months.
description: Body weight
measure: Body composition
time frame: Baseline
description: Body composition
measure: GLP-1
time frame: Baseline
description: GLP-1
measure: Change in HbA1c
time frame: 6 months
description: HbA1c.
measure: Change in fasting glucose
time frame: 6 months
description: fasting glucose
measure: fasting triglycerides
time frame: 6 months
description: fasting triglycerides
measure: Change in Body composition
time frame: 6 months
description: Body composition
measure: Change in GLP-1
time frame: 6 months
description: GLP-1
measure: fasting insulin
time frame: Baseline
description: fasting insulin
measure: total cholesterol
time frame: Baseline
description: total cholesterol
measure: LDL-cholesterol
time frame: Baseline
description: LDL-cholesterol
measure: HDL-cholesterol
time frame: Baseline
description: HDL-cholesterol
measure: GIP
time frame: Baseline
description: GIP
measure: change in fasting insulin
time frame: 6 months
description: fasting insulin
measure: change in total cholesterol
time frame: 6 months
description: total cholesterol
measure: change in LDL-cholesterol
time frame: 6 months
description: LDL-cholesterol
measure: change in HDL-cholesterol
time frame: 6 months
description: HDL-cholesterol
measure: change in GIP
time frame: 6 months
description: GIP
measure: C-peptide
time frame: baseline
measure: C-peptide
time frame: 6 months
measure: Homa-IR
time frame: baseline
measure: Homa-IR
time frame: 6 months
measure: Homa-Percent Beta
time frame: Baseline
measure: Homa-Percent Beta
time frame: 6 months
measure: Diet Quality
time frame: Three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
description: Determine the effect of substituting a wholesome snack food (almonds) for more traditional, less nutrient dense, snack foods on total diet quality. Food intake will be measured by the ASA-24 for three days (two non-consecutive week days and one weekend day) at baseline, month 2, 4, and 6.
measure: Compliance
time frame: Baseline, month 2, 4, and 6.
description: Demonstrate the utility of a novel, sensitive approach to document compliance with a prescription to ingest almonds on a daily basis for six months.
arm group label: Almond Group
arm group type: Experimental
description: Participants will consumed almonds every day for 6 months, but will not be allowed to consume any other nuts or nut products.
arm group label: Control Group
arm group type: Experimental
description: Participants will continue with their normal eating routine for 6 months, but will not be allowed to consume any nuts or nut products.
intervention type: Other
intervention name: Almonds
description: Participants will consume almonds everyday for 6 months.
arm group label: Almond Group
intervention type: Other
intervention name: Control (no nuts)
description: Participants will not be permited to consume any nuts for 6 months.
arm group label: Control Group
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: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Richard Mattes
investigator title: Professor, Nutrition Sciences
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
mesh term: Glucose Intolerance
mesh term: Lipid Metabolism Disorders
mesh term: Feeding and Eating Disorders
sharing ipd: No