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

About this trial
This is an interventional other trial for Weight Loss
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.
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
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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