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CompletedNCT04453254Updated Apr 8, 2024

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

An interventional study of Whole Food Meal and Supplement Food Meal in Weight Loss, sponsored by Skidmore College. Completed. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Skidmore College · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 years 2 months after the study started (first participant enrolled Apr 2013, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
Female
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Study 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. 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.

02

Conditions studied

  • Weight Loss

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03

In context

Weight Loss

1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.

This study's enrollment of 10 is below the median of 73 across 1,540 interventional studies indexed under Weight Loss.

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Lead sponsor

Skidmore College is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Young healthy females

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • 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.

    Other: 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.

    Other: Supplement Food Meal

Interventions

  • OtherWhole Food Meal

    Isocaloric/ macronutrient whole food meal

  • OtherSupplement Food Meal

    Isocaloric/ macronutrient supplement food meal

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial

Secondary outcomes

  1. Change in blood glucose

    Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.

    Time frame: Baseline line, 30, 60, 90, 120 minutes postprandial

  2. 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.

    Time frame: Baseline to 120 minutes postprandial

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Study locations

No study locations are listed for this record.

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References and documents

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 21228266 ↗
  • 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. PubMed 21178089 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04453254
Lead sponsor
Skidmore College
Responsible party
Sponsor
First posted
Jul 1, 2020
Start date
Apr 15, 2013
Primary completion
May 1, 2013
Completion
May 1, 2013
Last update
Apr 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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