Weight LossNCT04453254
The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
A study testing Whole Food Meal and Supplement Food Meal in people with Weight Loss, run by Skidmore College.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Whole Food Meal and Supplement Food Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2013to 1 May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young healthy females
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Weight Loss
- Being tested
- Whole Food Meal, Supplement Food Meal
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food MealOther
Isocaloric/ macronutrient whole food meal
Supplement Food MealOther
Isocaloric/ macronutrient supplement food meal
| Study group | Role | What they receive |
|---|---|---|
| Whole Food Meal | Active comparator | 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. Receives: Other: Whole Food Meal |
| Supplement Food Meal | Active comparator | A supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar. Receives: Other: Supplement Food Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
Secondary outcomes (2)
Change in blood glucose
Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.
Measured: Baseline line, 30, 60, 90, 120 minutes postprandial
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.
Measured: Baseline to 120 minutes postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start15 Apr 2013
- Primary completion1 May 2013
- Study completion1 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453254
- Sponsor's protocol ID
- 1302-333
- Status last verified
- Apr 2024
- First submitted
- 26 Jun 2020
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21228266Bailey 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.
PubMed 21178089
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
- ClinicalTrials.gov ID
- NCT04453254
- Acronym / sponsor ID
- 1302-333
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Study start
- 15 Apr 2013 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 May 2013 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Food Meal | Active comparator | Other: Whole Food MealA 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. |
| Supplement Food Meal | Active comparator | Other: Supplement Food MealA supplemental meal equivalent consisting of 1 cup 2% milk, 20 g whey protein, ½ EAS Myoplex bar, and ½ Balance bar. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young healthy females
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Food MealIsocaloric/ macronutrient whole food meal | Other | Whole Food Meal |
| Supplement Food MealIsocaloric/ macronutrient supplement food meal | Other | Supplement Food Meal |
Primary outcome
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.
2 secondary outcomes
Change in blood glucose
Time frame: Baseline line, 30, 60, 90, 120 minutes postprandial
Change in self-reported feelings of hunger, fullness, satiation
Time frame: Baseline to 120 minutes postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 21228266Acheson 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.
- Background: PubMed 21178089Bailey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Meal and Supplement Food Meal in people with Weight Loss, run by Skidmore College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.