<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/NCT03236181</url>
  </required_header>
  <id_info>
    <org_study_id>GFHNRC509</org_study_id>
    <nct_id>NCT03236181</nct_id>
  </id_info>
  <brief_title>Chronic Effects of Fats on Satiety &amp; Energy Needs</brief_title>
  <official_title>Chronic Effects of Fats on Satiety and Energy Expenditure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USDA Grand Forks Human Nutrition Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USDA Grand Forks 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 purpose of this study is to evaluate the effect of dietary fat on satiety (the experience&#xD;
      of fullness between one meal and the next) and energy metabolism over an extended period of&#xD;
      time (chronic effects). How dietary fat sources affect satiety, appetite and energy use is&#xD;
      unclear. The investigators will use a controlled setting for the studies. They want to know&#xD;
      if the source of dietary fat alters satiety, satiety hormones, and energy expenditure&#xD;
      responses after consuming different diets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This work will address the interaction of obesity and dietary fatty acids in regulating&#xD;
      satiety and energy metabolism. The primary objective is to determine the effects of chronic&#xD;
      intake of dietary fatty acids of varied saturation and chain length on satiety, thermogenesis&#xD;
      and energy utilization in healthy individuals. The investigators hypothesize that unsaturated&#xD;
      fatty acids will 1) increase satiety and 2) increase energy metabolism and that 3) the fatty&#xD;
      acid binding protein polymorphisms are associated with reduced energy expenditure in response&#xD;
      to dietary fat intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI is retiring from Center. Research will not continue with a new PI.&#xD;
  </why_stopped>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute effect of fat intake on energy expenditure as determined by metabolic rate</measure>
    <time_frame>Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Saturated Fat/SFA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monounsaturated Fat/MUFA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyunsaturated Fat Linoleic/PUFA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 grams high linoleic polyunsaturated fat (PUFA) in the form of high linoleic sunflower oil will be provided to subject in a mixed meal shake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyunsaturated Fat Omega-3/LCn3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SFA</intervention_name>
    <description>High saturated fatty acid/SFA oil source</description>
    <arm_group_label>Saturated Fat/SFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MUFA</intervention_name>
    <description>High monounsaturated fatty acid/MUFA oil source</description>
    <arm_group_label>Monounsaturated Fat/MUFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PUFA</intervention_name>
    <description>High polyunsaturated fatty acid (linoleic)/PUFA oil source</description>
    <arm_group_label>Polyunsaturated Fat Linoleic/PUFA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LCn3</intervention_name>
    <description>High polyunsaturated fatty acid (omega-3)/LCn3 oil source</description>
    <arm_group_label>Polyunsaturated Fat Omega-3/LCn3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index between 25.0-34.9 kg/m2&#xD;
&#xD;
          -  free of major diagnosed, untreated medical conditions&#xD;
&#xD;
          -  non-smoking or use of other tobacco products, including e-cigarettes&#xD;
&#xD;
          -  not taking steroid-based medications&#xD;
&#xD;
          -  not planning to or currently attempting to gain or lose weight&#xD;
&#xD;
          -  willing to comply with study demands&#xD;
&#xD;
          -  low intake of long chain omega-3 fatty acids (&lt;0.10 g/d) or willing to reduce intake&#xD;
             for 6 weeks prior to starting the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed eating disorders&#xD;
&#xD;
          -  diabetes (blood sugar ≥ 126 mg/dl)&#xD;
&#xD;
          -  hypertension (systolic &gt; 160 mmHg or diastolic &gt; 100 mmHg)&#xD;
&#xD;
          -  diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases&#xD;
&#xD;
          -  currently pregnant or planning to become pregnant, or lactating&#xD;
&#xD;
          -  taking medications known to affect appetite, blood lipids, body composition, body&#xD;
             weight, or food intake (appetite control drugs, steroids, antidepressants)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Raatz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USDA Grand Forks Human Nutrition Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USDA Grand Forks Human Nutrition Research Center</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 28, 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>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Energy Expenditure</keyword>
  <keyword>Appetite</keyword>
  <keyword>Satiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03236181
org study id: GFHNRC509
nct id: NCT03236181
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of dietary fat on satiety (the experience
      of fullness between one meal and the next) and energy metabolism over an extended period of
      time (chronic effects). How dietary fat sources affect satiety, appetite and energy use is
      unclear. The investigators will use a controlled setting for the studies. They want to know
      if the source of dietary fat alters satiety, satiety hormones, and energy expenditure
      responses after consuming different diets.
This work will address the interaction of obesity and dietary fatty acids in regulating
      satiety and energy metabolism. The primary objective is to determine the effects of chronic
      intake of dietary fatty acids of varied saturation and chain length on satiety, thermogenesis
      and energy utilization in healthy individuals. The investigators hypothesize that unsaturated
      fatty acids will 1) increase satiety and 2) increase energy metabolism and that 3) the fatty
      acid binding protein polymorphisms are associated with reduced energy expenditure in response
      to dietary fat intake.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Acute effect of fat intake on energy expenditure as determined by metabolic rate
time frame: Incremental Area Under the Curve (iAUC) of metabolic rate from 0 to 4 hours
arm group label: Saturated Fat/SFA
arm group type: Other
description: 30 grams saturated fat (SFA) in the form of heavy whipping cream will be provided to subject in a mixed meal shake
arm group label: Monounsaturated Fat/MUFA
arm group type: Other
description: 30 grams monounsaturated fat (MUFA) in the form of olive oil will be provided to subject in a mixed meal shake
arm group label: Polyunsaturated Fat Linoleic/PUFA
arm group type: Other
description: 30 grams high linoleic polyunsaturated fat (PUFA) in the form of high linoleic sunflower oil will be provided to subject in a mixed meal shake
arm group label: Polyunsaturated Fat Omega-3/LCn3
arm group type: Other
description: 30 grams high omega-3 polyunsaturated fat (LCn3) in the form of fish oil will be provided to subject in a mixed meal shake
intervention type: Other
intervention name: SFA
description: High saturated fatty acid/SFA oil source
arm group label: Saturated Fat/SFA
intervention type: Other
intervention name: MUFA
description: High monounsaturated fatty acid/MUFA oil source
arm group label: Monounsaturated Fat/MUFA
intervention type: Other
intervention name: PUFA
description: High polyunsaturated fatty acid (linoleic)/PUFA oil source
arm group label: Polyunsaturated Fat Linoleic/PUFA
intervention type: Other
intervention name: LCn3
description: High polyunsaturated fatty acid (omega-3)/LCn3 oil source
arm group label: Polyunsaturated Fat Omega-3/LCn3
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Raatz, PhD
role: Principal Investigator
affiliation: USDA Grand Forks Human Nutrition Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No