<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/NCT04453254</url>
  </required_header>
  <id_info>
    <org_study_id>1302-333</org_study_id>
    <nct_id>NCT04453254</nct_id>
  </id_info>
  <brief_title>The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent</brief_title>
  <official_title>The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Skidmore College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Skidmore College</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>
      There is limited research on the amount of calories burned and metabolic differences of a&#xD;
      complete supplemental meal in comparison to a whole food meal. The purpose of this study is&#xD;
      to analyze the differences in calories burned and metabolic response post-consumption of a&#xD;
      meal consisting of whole foods compared to its nutritionally engineered equivalent. We&#xD;
      hypothesize that energy expenditure and satiety will be greater in the whole food meal&#xD;
      compared to the supplement meal, whereas, there will be no difference in levels of glucose&#xD;
      between the two conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 50% of U.S. adults today use some form of dietary supplementation to obtain their&#xD;
      nutrient intake (Bailey et al., 2011). Previous research has shown that certain nutritional&#xD;
      supplements may produce varying metabolic and thermogenic (calories burned) responses, when&#xD;
      compared to other food sources (Acheson et al., 2011). The difference in thermogenic response&#xD;
      may also suggest that there is a difference between a whole food meal and its supplemental&#xD;
      equivalent. If there is a difference in thermogenic response, this may indicate that a&#xD;
      meal-replacing supplement, such as a ready-to-drink-shake and/or food bar may not induce the&#xD;
      same health benefits as a whole food meal in terms of nutrient digestion, absorption,&#xD;
      metabolism and storage. There has not been extensive research on the thermic effect and&#xD;
      metabolic differences of a complete supplemental meal in comparison to a whole food meal. The&#xD;
      purpose of our study is to analyze the differences in thermogenic and metabolic response&#xD;
      post-consumption of a meal consisting of whole foods compared to its supplemental, engineered&#xD;
      equivalent. We hypothesize that energy expenditure and satiety will be greater in the whole&#xD;
      food meal compared to the supplement meal, whereas, there will be no difference in levels of&#xD;
      glucose between the two conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2013</start_date>
  <completion_date type="Actual">May 1, 2013</completion_date>
  <primary_completion_date type="Actual">May 1, 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thermic effect of meals (TEM) also known as postprandial thermogenesis</measure>
    <time_frame>Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial</time_frame>
    <description>The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Following meal ingestion, participants will rest quietly for 2 hours during which time their resting energy expenditure will be measured every other 15 minutes for 15 minutes. For example, they will have their resting energy expenditure measured during minutes 15-30, 45-60, 75-90 105-120 following meal ingestion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood glucose</measure>
    <time_frame>Baseline line, 30, 60, 90, 120 minutes postprandial</time_frame>
    <description>Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported feelings of hunger, fullness, satiation</measure>
    <time_frame>Baseline to 120 minutes postprandial</time_frame>
    <description>Visual analog scale of hunger, fullness and satiation using a 100 mm line which subjects place a mark. Closer to 0 mm indicates no feeling at a ll, 100 mm indicates extreme feelings.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Whole Food Meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A whole meal consisting of 1 cup 2% milk, 1 cup Kashi Go Lean Original cereal, ¼ cup of almonds, ¼ cup of strawberries, and ¼ cup of raspberries.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supplement Food Meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole Food Meal</intervention_name>
    <description>Isocaloric/ macronutrient whole food meal</description>
    <arm_group_label>Whole Food Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supplement Food Meal</intervention_name>
    <description>Isocaloric/ macronutrient supplement food meal</description>
    <arm_group_label>Supplement Food Meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young healthy females&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with specific dietary needs.&#xD;
&#xD;
          -  This with diabetes, impaired fasting glucose, low blood sugar (hypoglycemia) and&#xD;
             participants who are classified as high risk.&#xD;
&#xD;
          -  Participants with lactose intolerance.&#xD;
&#xD;
          -  Participants who regularly use dietary supplements.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Acheson KJ, Blondel-Lubrano A, Oguey-Araymon S, Beaumont M, Emady-Azar S, Ammon-Zufferey C, Monnard I, Pinaud S, Nielsen-Moennoz C, Bovetto L. Protein choices targeting thermogenesis and metabolism. Am J Clin Nutr. 2011 Mar;93(3):525-34. doi: 10.3945/ajcn.110.005850. Epub 2011 Jan 12.</citation>
    <PMID>21228266</PMID>
  </reference>
  <reference>
    <citation>Bailey RL, Gahche JJ, Lentino CV, Dwyer JT, Engel JS, Thomas PR, Betz JM, Sempos CT, Picciano MF. Dietary supplement use in the United States, 2003-2006. J Nutr. 2011 Feb;141(2):261-6. doi: 10.3945/jn.110.133025. Epub 2010 Dec 22.</citation>
    <PMID>21178089</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT04453254
org study id: 1302-333
nct id: NCT04453254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is limited research on the amount of calories burned and metabolic differences of a
      complete supplemental meal in comparison to a whole food meal. The purpose of this study is
      to analyze the differences in calories burned and metabolic response post-consumption of a
      meal consisting of whole foods compared to its nutritionally engineered equivalent. We
      hypothesize that energy expenditure and satiety will be greater in the whole food meal
      compared to the supplement meal, whereas, there will be no difference in levels of glucose
      between the two conditions.
Over 50% of U.S. adults today use some form of dietary supplementation to obtain their
      nutrient intake (Bailey et al., 2011). Previous research has shown that certain nutritional
      supplements may produce varying metabolic and thermogenic (calories burned) responses, when
      compared to other food sources (Acheson et al., 2011). The difference in thermogenic response
      may also suggest that there is a difference between a whole food meal and its supplemental
      equivalent. If there is a difference in thermogenic response, this may indicate that a
      meal-replacing supplement, such as a ready-to-drink-shake and/or food bar may not induce the
      same health benefits as a whole food meal in terms of nutrient digestion, absorption,
      metabolism and storage. There has not been extensive research on the thermic effect and
      metabolic differences of a complete supplemental meal in comparison to a whole food meal. The
      purpose of our study is to analyze the differences in thermogenic and metabolic response
      post-consumption of a meal consisting of whole foods compared to its supplemental, engineered
      equivalent. We hypothesize that energy expenditure and satiety will be greater in the whole
      food meal compared to the supplement meal, whereas, there will be no difference in levels of
      glucose between the two conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Thermic effect of meals (TEM) also known as postprandial thermogenesis
time frame: Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
description: The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Following meal ingestion, participants will rest quietly for 2 hours during which time their resting energy expenditure will be measured every other 15 minutes for 15 minutes. For example, they will have their resting energy expenditure measured during minutes 15-30, 45-60, 75-90 105-120 following meal ingestion.
measure: Change in blood glucose
time frame: Baseline line, 30, 60, 90, 120 minutes postprandial
description: Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.
measure: Change in self-reported feelings of hunger, fullness, satiation
time frame: Baseline to 120 minutes postprandial
description: Visual analog scale of hunger, fullness and satiation using a 100 mm line which subjects place a mark. Closer to 0 mm indicates no feeling at a ll, 100 mm indicates extreme feelings.
arm group label: Whole Food Meal
arm group type: Active Comparator
description: A whole meal consisting of 1 cup 2% milk, 1 cup Kashi Go Lean Original cereal, ¼ cup of almonds, ¼ cup of strawberries, and ¼ cup of raspberries.
arm group label: Supplement Food Meal
arm group type: Active Comparator
description: A supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar.
intervention type: Other
intervention name: Whole Food Meal
description: Isocaloric/ macronutrient whole food meal
arm group label: Whole Food Meal
intervention type: Other
intervention name: Supplement Food Meal
description: Isocaloric/ macronutrient supplement food meal
arm group label: Supplement Food Meal
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Acheson KJ, Blondel-Lubrano A, Oguey-Araymon S, Beaumont M, Emady-Azar S, Ammon-Zufferey C, Monnard I, Pinaud S, Nielsen-Moennoz C, Bovetto L. Protein choices targeting thermogenesis and metabolism. Am J Clin Nutr. 2011 Mar;93(3):525-34. doi: 10.3945/ajcn.110.005850. Epub 2011 Jan 12.
PMID: 21228266
citation: Bailey RL, Gahche JJ, Lentino CV, Dwyer JT, Engel JS, Thomas PR, Betz JM, Sempos CT, Picciano MF. Dietary supplement use in the United States, 2003-2006. J Nutr. 2011 Feb;141(2):261-6. doi: 10.3945/jn.110.133025. Epub 2010 Dec 22.
PMID: 21178089
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No