- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453254
The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
April 5, 2024 updated by: Skidmore College
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.
Investigators hypothesize that energy expenditure and satiety will be greater following consumption of the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Over 50% of U.S. adults today use some form of dietary supplementation to obtain their nutrient intake.
Previous research has shown that certain nutritional supplements may produce varying metabolic and thermogenic (calories burned) responses, when compared to other food sources.
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 this 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.
It's hypothesized that energy expenditure and satiety will be greater following the whole food meal compared to the supplement meal, whereas, there will be no difference in levels of glucose between the two conditions.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Young healthy females
Exclusion Criteria:
- Participants with specific dietary needs.
- Those 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Whole Food Meal
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.
|
Isocaloric/ macronutrient whole food meal
|
|
Active Comparator: Supplement Food Meal
A supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar.
|
Isocaloric/ macronutrient supplement food meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thermic effect of meals (TEM) also known as postprandial thermogenesis
Time Frame: Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
|
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.
|
Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood glucose
Time Frame: Baseline line, 30, 60, 90, 120 minutes postprandial
|
Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.
|
Baseline line, 30, 60, 90, 120 minutes postprandial
|
|
Change in self-reported feelings of hunger, fullness, satiation
Time Frame: Baseline to 120 minutes postprandial
|
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.
|
Baseline to 120 minutes postprandial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
June 26, 2020
First Posted (Actual)
July 1, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1302-333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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