<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/NCT04484974</url>
  </required_header>
  <id_info>
    <org_study_id>20-0048</org_study_id>
    <nct_id>NCT04484974</nct_id>
  </id_info>
  <brief_title>Effects of Pecan Nut Snacks v Equicaloric Snacks on Appetite, Food Intake, Metabolism, Hormones and Biomarkers</brief_title>
  <official_title>A Randomized, Two Condition, Crossover Trial Assessing Appetite, Energy Metabolism, Blood Biomarker and ad Libitum Food Intake Responses to a Mid-morning Pecan Snack vs. an Equicaloric High Carbohydrate Savory Snack in Healthy Volunteers With Overweight/Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Pecan Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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 is a within-subjects crossover study that examines subjective appetite, food intake,&#xD;
      hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as&#xD;
      compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and&#xD;
      low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially&#xD;
      devoid of fat. These two very different nutrient profiles should elicit different metabolic&#xD;
      and biomarker responses. The study aims to determine whether these treatments also elicit&#xD;
      different subjective appetite and food intake responses. Participants will be healthy&#xD;
      volunteers with overweight and obesity, a population that may be seeking healthy snacking&#xD;
      options that are satisfying and satiating.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, two condition, crossover study in healthy individuals with overweight&#xD;
      and obesity examining the effect of a mid-morning snack of pecans vs. a low fat savory snack&#xD;
      on appetite, energy expenditure, blood biomarkers of appetite and metabolism and ad libitum&#xD;
      food intake at lunch. Twenty-four participants will be enrolled and studied on two test days&#xD;
      with at least one week washout in between. On test days, participants will have baseline&#xD;
      measures of appetite (by Visual Analogue Scale (VAS)), blood hormones and substrates, and&#xD;
      energy expenditure and fuel oxidation (Resting Metabolic Rate (RMR), by indirect calorimetry)&#xD;
      taken just prior to consuming a standardized 300 kcal breakfast. VAS measures will be taken&#xD;
      at 20, 30, 60, 90 and 120 min following the meal and RMR will be measured for 20 min after&#xD;
      eating. A mid-morning snack of either 250 kcal of pecans or lightly salted tortilla chips&#xD;
      will be consumed and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min&#xD;
      following the snack and RMR will be measured for 20 min after eating. Participants will be&#xD;
      given an ad libitum lunch meal and VAS and blood measures will be taken at 20, 30, 60, 90 and&#xD;
      120 min following the lunch and RMR will be measured for 20 min after eating. Blood will be&#xD;
      analyzed for glucose, insulin, free fatty acids, triglycerides, ghrelin, leptin, PYY, and&#xD;
      GLP-1. Two hypotheses will be examined: 1. pecans will provoke greater feelings of fullness&#xD;
      and reduced hunger after the snack and lunch meal consumption (on either a calorie per&#xD;
      calorie or volume basis) as compared to the tortilla chip snack, and 2. the pecan snack will&#xD;
      provoke greater responses of satiety hormones compared to tortilla chips. Post-snack and&#xD;
      lunch energy expenditure and fat oxidation will also be compared between treatments as an&#xD;
      exploratory aim.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>
    <intervention_model_description>Randomized, two period crossover with two treatment conditions</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The two treatments are pecan nuts or tortilla chips as snacks, therefore masking of treatment conditions is not possible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment</measure>
    <time_frame>Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.</time_frame>
    <description>Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: &quot;How hungry are you right now?&quot; and anchored on the left by &quot;not at all hungry&quot; and by &quot;extremely hungry&quot; on the right; Fullness will be queried by &quot;How full do you feel right now?&quot; anchored by &quot;not at all...&quot; and &quot;extremely...&quot;; Desire to eat will be queried by, &quot;How strong is your desire to eat right now?&quot; anchored by anchored by &quot;not at all...&quot; and &quot;extreme...; and prospective consumption will be queried by, &quot;how much food do you think you can you eat right now&quot; with anchors of &quot;not (much) at all&quot; to &quot;extremely/an extreme amount&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment</measure>
    <time_frame>Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.</time_frame>
    <description>Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: &quot;How hungry are you right now?&quot; and anchored on the left by &quot;not at all hungry&quot; and by &quot;extremely hungry&quot; on the right; Fullness will be queried by &quot;How full do you feel right now?&quot; anchored by &quot;not at all...&quot; and &quot;extremely...&quot;; Desire to eat will be queried by, &quot;How strong is your desire to eat right now?&quot; anchored by anchored by &quot;not at all...&quot; and &quot;extreme...; and prospective consumption will be queried by, &quot;how much food do you think you can you eat right now&quot; with anchors of &quot;not (much) at all&quot; to &quot;extremely/an extreme amount&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy intake response to pecan or pretzel snack using weighed food intake measures</measure>
    <time_frame>30 minutes allowed for completion of the lunch meal</time_frame>
    <description>Energy intake at ad libitum lunch meal consisting of a variety of different foods offering approximately 1400 of kilocalories of energy having an overall composition of approximately 15% protein, 55% carbohydrate and 30% fat. Twelve ounces of water will be provided as the beverage. Energy intake will be calculated from the weight of each food consumed and the published nutrient composition of the foods. Linear mixed effects model will be used to test the difference in energy intake between two experimental conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.</measure>
    <time_frame>Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.</time_frame>
    <description>Serum glucose by enzymatic method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum glucose by enzymatic method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.</measure>
    <time_frame>Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.</time_frame>
    <description>Serum insulin by radio-immunoassay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum insulin by radio-immunoassay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.</measure>
    <time_frame>Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.</time_frame>
    <description>Serum triglycerides by enzymatic assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum triglycerides by enzymatic assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.</measure>
    <time_frame>Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.</time_frame>
    <description>Serum free fatty acids by enzymatic assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum free fatty acids by enzymatic assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.</measure>
    <time_frame>Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.</time_frame>
    <description>Serum ghrelin by radio-immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum ghrelin by radio-immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.</measure>
    <time_frame>Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.</time_frame>
    <description>Serum peptide YY (PYY) by radio-immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum peptide YY (PYY) by radio-immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.</measure>
    <time_frame>Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.</time_frame>
    <description>Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.</measure>
    <time_frame>Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.</time_frame>
    <description>Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum leptin from baseline to 120 minutes following snack consumption</measure>
    <time_frame>Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.</time_frame>
    <description>Serum leptin by immunoassay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in energy expenditure post snack</measure>
    <time_frame>Resting energy expenditure will be measured for 20 minutes after snack consumption.</time_frame>
    <description>Post snack resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in energy expenditure post lunch</measure>
    <time_frame>Resting energy expenditure will be measured for 20 minutes after lunch consumption.</time_frame>
    <description>Post lunch resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Pecan snack condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tortilla chip snack condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pecan snack</intervention_name>
    <description>Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.</description>
    <arm_group_label>Pecan snack condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tortilla chip snack</intervention_name>
    <description>Under this condition, each participant will consume a mid morning snack consisting of an iso-caloric (equal to the pecan snack) snack of tortilla chips followed by an ad libitum lunch.</description>
    <arm_group_label>Tortilla chip snack condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 35 adult men and women&#xD;
&#xD;
          2. all ethnic groups&#xD;
&#xD;
          3. ages 20-50,&#xD;
&#xD;
          4. BMI 27-35,&#xD;
&#xD;
          5. habitually eat breakfast,&#xD;
&#xD;
          6. willing to eat the test snacks and other foods offered,&#xD;
&#xD;
          7. weight stable for the last 6 months&#xD;
&#xD;
          8. willing to consent and adhere to the test procedures and schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. nut allergies,&#xD;
&#xD;
          2. uncontrolled thyroid disorders,&#xD;
&#xD;
          3. diabetes mellitus,&#xD;
&#xD;
          4. eating disorders,&#xD;
&#xD;
          5. pregnant, or planning to become pregnant during the study,&#xD;
&#xD;
          6. lactating,&#xD;
&#xD;
          7. uncontrolled hypertension,&#xD;
&#xD;
          8. active dieting&#xD;
&#xD;
          9. intensive physical activity training regimen (&gt;300 min/wk exercise),&#xD;
&#xD;
         10. medical history or current medication that may affect study outcomes per study PI&#xD;
             discretion&#xD;
&#xD;
         11. consuming pecans on a regular basis&#xD;
&#xD;
         12. unable to lie still with a clear hood over their head for the measurement of energy&#xD;
             expenditure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John C Peters, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John C Peters, PhD</last_name>
    <phone>13037249160</phone>
    <email>john.c.peters@cuanschutz.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeanne Anne Breen, MS</last_name>
    <phone>13037249015</phone>
    <email>jeanneanne.breen@cuanschutz.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Colorado Anschutz Health and Wellness Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John C Peters, PhD</last_name>
      <phone>303-724-9160</phone>
      <email>john.c.peters@cuanschutz.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jeanne Anne Breen, MS</last_name>
      <phone>303-724-9015</phone>
      <email>jeanneanne.breen@cuanschutz.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Marc A Cornier, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>John C Peters, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pecans</keyword>
  <keyword>appetite</keyword>
  <keyword>hormones</keyword>
  <keyword>food intake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT04484974
org study id: 20-0048
nct id: NCT04484974
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a within-subjects crossover study that examines subjective appetite, food intake,
      hormone and metabolic responses to consumption of mid morning snacks of pecan nuts as
      compared to an iso-caloric amount of tortilla chips. Pecans are high in fat and calories and
      low in carbohydrate by weight, while tortilla chips are mostly carbohydrate and essentially
      devoid of fat. These two very different nutrient profiles should elicit different metabolic
      and biomarker responses. The study aims to determine whether these treatments also elicit
      different subjective appetite and food intake responses. Participants will be healthy
      volunteers with overweight and obesity, a population that may be seeking healthy snacking
      options that are satisfying and satiating.
This is a randomized, two condition, crossover study in healthy individuals with overweight
      and obesity examining the effect of a mid-morning snack of pecans vs. a low fat savory snack
      on appetite, energy expenditure, blood biomarkers of appetite and metabolism and ad libitum
      food intake at lunch. Twenty-four participants will be enrolled and studied on two test days
      with at least one week washout in between. On test days, participants will have baseline
      measures of appetite (by Visual Analogue Scale (VAS)), blood hormones and substrates, and
      energy expenditure and fuel oxidation (Resting Metabolic Rate (RMR), by indirect calorimetry)
      taken just prior to consuming a standardized 300 kcal breakfast. VAS measures will be taken
      at 20, 30, 60, 90 and 120 min following the meal and RMR will be measured for 20 min after
      eating. A mid-morning snack of either 250 kcal of pecans or lightly salted tortilla chips
      will be consumed and VAS and blood measures will be taken at 20, 30, 60, 90 and 120 min
      following the snack and RMR will be measured for 20 min after eating. Participants will be
      given an ad libitum lunch meal and VAS and blood measures will be taken at 20, 30, 60, 90 and
      120 min following the lunch and RMR will be measured for 20 min after eating. Blood will be
      analyzed for glucose, insulin, free fatty acids, triglycerides, ghrelin, leptin, PYY, and
      GLP-1. Two hypotheses will be examined: 1. pecans will provoke greater feelings of fullness
      and reduced hunger after the snack and lunch meal consumption (on either a calorie per
      calorie or volume basis) as compared to the tortilla chip snack, and 2. the pecan snack will
      provoke greater responses of satiety hormones compared to tortilla chips. Post-snack and
      lunch energy expenditure and fat oxidation will also be compared between treatments as an
      exploratory aim.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, two period crossover with two treatment conditions
primary purpose: Basic Science
masking: None (Open Label)
masking description: The two treatments are pecan nuts or tortilla chips as snacks, therefore masking of treatment conditions is not possible.
measure: Change from baseline (before snack consumption) to 120 minutes in subjective appetite response to pecan or pretzel snack using visual analog assessment
time frame: Baseline (prior to mid-morning snack consumption) to 120 minutes after snack consumption at 20, 30, 60, 90 and 120 minutes following consumption.
description: Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
measure: Change from baseline (prior to lunch) to 120 minutes in subjective appetite response to lunch meal using visual analog assessment
time frame: Prior to lunch consumption and at 20, 30, 60, 90 and 120 minutes following consumption.
description: Subjective appetite will be assessed using a visual analog scale. Subjective feelings will be rated on a 100 mm horizontal line preceded by the questions: "How hungry are you right now?" and anchored on the left by "not at all hungry" and by "extremely hungry" on the right; Fullness will be queried by "How full do you feel right now?" anchored by "not at all..." and "extremely..."; Desire to eat will be queried by, "How strong is your desire to eat right now?" anchored by anchored by "not at all..." and "extreme...; and prospective consumption will be queried by, "how much food do you think you can you eat right now" with anchors of "not (much) at all" to "extremely/an extreme amount".
measure: Energy intake response to pecan or pretzel snack using weighed food intake measures
time frame: 30 minutes allowed for completion of the lunch meal
description: Energy intake at ad libitum lunch meal consisting of a variety of different foods offering approximately 1400 of kilocalories of energy having an overall composition of approximately 15% protein, 55% carbohydrate and 30% fat. Twelve ounces of water will be provided as the beverage. Energy intake will be calculated from the weight of each food consumed and the published nutrient composition of the foods. Linear mixed effects model will be used to test the difference in energy intake between two experimental conditions.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum glucose following pecan or pretzel snack consumption.
time frame: Baseline (prior to snack) to 120 minutes at intervals of 20, 30, 60, 90 and 120 minutes.
description: Serum glucose by enzymatic method.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum glucose following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum glucose by enzymatic method.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum insulin following pecan or pretzel snack consumption.
time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
description: Serum insulin by radio-immunoassay.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum insulin following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum insulin by radio-immunoassay.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum triglycerides following pecan or pretzel snack consumption.
time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
description: Serum triglycerides by enzymatic assay.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum triglycerides following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum triglycerides by enzymatic assay.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum free fatty acids following snack consumption.
time frame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
description: Serum free fatty acids by enzymatic assay.
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum free fatty acids following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum free fatty acids by enzymatic assay.
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum ghrelin following snack consumption.
time frame: Prior to mid-morning snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
description: Serum ghrelin by radio-immunoassay
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum ghrelin following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum ghrelin by radio-immunoassay
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum peptide YY following snack consumption.
time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
description: Serum peptide YY (PYY) by radio-immunoassay
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum peptide YY following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum peptide YY (PYY) by radio-immunoassay
measure: Change from baseline (prior to snack consumption) to 120 minutes in serum glucagon like peptide-1 following snack consumption.
time frame: Prior to snack and at intervals of 20, 30, 60, 90 and 120 minutes after snack consumption.
description: Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
measure: Change from baseline (prior to lunch consumption) to 120 minutes in serum glucagon like peptide-1 following lunch consumption.
time frame: Prior to lunch and at intervals of 20, 30, 60, 90 and 120 minutes after lunch consumption.
description: Serum glucagon like peptide-1 (GLP-1) by enzyme immunoassay
measure: Change in serum leptin from baseline to 120 minutes following snack consumption
time frame: Baseline (prior to breakfast) and at 120 minutes following mid-morning snack consumption.
description: Serum leptin by immunoassay.
measure: Change from baseline in energy expenditure post snack
time frame: Resting energy expenditure will be measured for 20 minutes after snack consumption.
description: Post snack resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).
measure: Change from baseline in energy expenditure post lunch
time frame: Resting energy expenditure will be measured for 20 minutes after lunch consumption.
description: Post lunch resting energy expenditure will be measured using hood indirect calorimetry. Energy expenditure will be measured using standard indirect calorimetry with the ventilated hood technique (Parvo Medics Truemax 2400, Salt Lake City, UT).
arm group label: Pecan snack condition
arm group type: Experimental
description: In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted roasted pecan nuts will be administered.
arm group label: Tortilla chip snack condition
arm group type: Active Comparator
description: In this crossover condition, a mid morning snack consisting of 250 kcal of lightly salted pretzels will be administered.
intervention type: Other
intervention name: Pecan snack
description: Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.
arm group label: Pecan snack condition
intervention type: Other
intervention name: Tortilla chip snack
description: Under this condition, each participant will consume a mid morning snack consisting of an iso-caloric (equal to the pecan snack) snack of tortilla chips followed by an ad libitum lunch.
arm group label: Tortilla chip snack condition
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John C Peters, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: John C Peters, PhD
phone: 13037249160
email: john.c.peters@cuanschutz.edu
last name: Jeanne Anne Breen, MS
phone: 13037249015
email: jeanneanne.breen@cuanschutz.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No