<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/NCT03247881</url>
  </required_header>
  <id_info>
    <org_study_id>HS57</org_study_id>
    <nct_id>NCT03247881</nct_id>
  </id_info>
  <brief_title>Pilot Study on Mixed Nuts and Food Intake</brief_title>
  <official_title>Pilot Study on Mixed Nuts and Food Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Beltsville Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Beltsville Human Nutrition Research Center</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>
      The objectives of this study are 1) to determine if consumption of mixed nuts influences food&#xD;
      intake and choice, and 2) to determine how personality traits affect food choice, including&#xD;
      mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food&#xD;
      intake control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The condition of being overweight or obese has skyrocketed in recent decades, bringing with&#xD;
      it many secondary health problems. Therefore, it is important to seek strategies to promote&#xD;
      weight loss and to assist in weight maintenance after weight loss. Different diet&#xD;
      compositions may have different effects on satiety and thus affect food choice. A pilot study&#xD;
      will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires&#xD;
      will also be administered to determine if personality characteristics are also influencing&#xD;
      food choice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">November 6, 2017</completion_date>
  <primary_completion_date type="Actual">November 6, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass will be measured</measure>
    <time_frame>Day 0, prior to beginning the diet, day 8, day 29, and day 60</time_frame>
    <description>To track the change in body mass, subjects will be weighed on a scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaires will be administered</measure>
    <time_frame>Once during the study, no specific time.</time_frame>
    <description>Questionnaires addressing control of eating, eating attitude, social approval, and social desirability will be administered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood questionnaire will be administered</measure>
    <time_frame>Day 0, Day 8, and Day 29.</time_frame>
    <description>A mood questionnaire will be administered.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Nut Free Diet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Added Mixed Nuts Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nut Free Diet</intervention_name>
    <description>Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.</description>
    <arm_group_label>Nut Free Diet</arm_group_label>
    <other_name>Control Diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Added Mixed Nuts Diet</intervention_name>
    <description>Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).</description>
    <arm_group_label>Added Mixed Nuts Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  21 to 60 Years Old&#xD;
&#xD;
          -  5 year cancer-free&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant, lactating, or intending to become pregnant during the study&#xD;
&#xD;
          -  known allergy to study foods, including nuts&#xD;
&#xD;
          -  use of tobacco products&#xD;
&#xD;
          -  history of bariatric surgery or nutrient malabsorption disease or diseases requiring&#xD;
             special diet&#xD;
&#xD;
          -  Crohn's disease or diverticulitis&#xD;
&#xD;
          -  suspected or known strictures, fistulas, or physiological/mechanical GI obstruction&#xD;
&#xD;
          -  Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots&#xD;
&#xD;
          -  Self report of alcohol or substance abuse within the past 12 months and/or current&#xD;
             acute treatment or participation in a rehabilitation program for those problems&#xD;
             (long-term participation in Alcoholics Anonymous is not an exclusion)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet Novotny</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA-ARS, Beltsville Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA-ARS Beltsville Human Nutrition Research Center</name>
      <address>
        <city>Beltsville</city>
        <state>Maryland</state>
        <zip>20705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>USDA Beltsville Human Nutrition Research Center</investigator_affiliation>
    <investigator_full_name>Janet Novotny</investigator_full_name>
    <investigator_title>Research Physiologist</investigator_title>
  </responsible_party>
  <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/NCT03247881
org study id: HS57
nct id: NCT03247881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of this study are 1) to determine if consumption of mixed nuts influences food
      intake and choice, and 2) to determine how personality traits affect food choice, including
      mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food
      intake control.
The condition of being overweight or obese has skyrocketed in recent decades, bringing with
      it many secondary health problems. Therefore, it is important to seek strategies to promote
      weight loss and to assist in weight maintenance after weight loss. Different diet
      compositions may have different effects on satiety and thus affect food choice. A pilot study
      will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires
      will also be administered to determine if personality characteristics are also influencing
      food choice.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Body Mass will be measured
time frame: Day 0, prior to beginning the diet, day 8, day 29, and day 60
description: To track the change in body mass, subjects will be weighed on a scale.
measure: Questionnaires will be administered
time frame: Once during the study, no specific time.
description: Questionnaires addressing control of eating, eating attitude, social approval, and social desirability will be administered.
measure: Mood questionnaire will be administered
time frame: Day 0, Day 8, and Day 29.
description: A mood questionnaire will be administered.
arm group label: Nut Free Diet
arm group type: Other
description: Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.
arm group label: Added Mixed Nuts Diet
arm group type: Active Comparator
description: Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).
intervention type: Other
intervention name: Nut Free Diet
description: Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.
arm group label: Nut Free Diet
other name: Control Diet
intervention type: Other
intervention name: Added Mixed Nuts Diet
description: Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).
arm group label: Added Mixed Nuts Diet
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janet Novotny
role: Principal Investigator
affiliation: USDA-ARS, Beltsville Human Nutrition Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: USDA Beltsville Human Nutrition Research Center
investigator full name: Janet Novotny
investigator title: Research Physiologist
sharing ipd: No