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The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole Food Meal
Supplement Food Meal
Sponsored by
Skidmore College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Loss

Eligibility Criteria

18 Years - 24 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Young healthy females

Exclusion Criteria:

  • Participants with specific dietary needs.
  • This with diabetes, impaired fasting glucose, low blood sugar (hypoglycemia) and participants who are classified as high risk.
  • Participants with lactose intolerance.
  • Participants who regularly use dietary supplements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Whole Food Meal

    Supplement Food Meal

    Arm 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.

    A supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar.

    Outcomes

    Primary Outcome Measures

    Thermic effect of meals (TEM) also known as postprandial thermogenesis
    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.

    Secondary Outcome Measures

    Change in blood glucose
    Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.
    Change in self-reported feelings of hunger, fullness, satiation
    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.

    Full Information

    First Posted
    June 26, 2020
    Last Updated
    June 26, 2020
    Sponsor
    Skidmore College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04453254
    Brief Title
    The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
    Official Title
    The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 15, 2013 (Actual)
    Primary Completion Date
    May 1, 2013 (Actual)
    Study Completion Date
    May 1, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Skidmore College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Whole Food Meal
    Arm Type
    Active Comparator
    Arm 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 Title
    Supplement Food Meal
    Arm Type
    Active Comparator
    Arm 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(s)
    Whole Food Meal
    Intervention Description
    Isocaloric/ macronutrient whole food meal
    Intervention Type
    Other
    Intervention Name(s)
    Supplement Food Meal
    Intervention Description
    Isocaloric/ macronutrient supplement food meal
    Primary Outcome Measure Information:
    Title
    Thermic effect of meals (TEM) also known as postprandial thermogenesis
    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.
    Time Frame
    Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
    Secondary Outcome Measure Information:
    Title
    Change in blood glucose
    Description
    Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.
    Time Frame
    Baseline line, 30, 60, 90, 120 minutes postprandial
    Title
    Change in self-reported feelings of hunger, fullness, satiation
    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.
    Time Frame
    Baseline to 120 minutes postprandial

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Young healthy females Exclusion Criteria: Participants with specific dietary needs. This with diabetes, impaired fasting glucose, low blood sugar (hypoglycemia) and participants who are classified as high risk. Participants with lactose intolerance. Participants who regularly use dietary supplements.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21228266
    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.
    Results Reference
    background
    PubMed Identifier
    21178089
    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.
    Results Reference
    background

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    The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent

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