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

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.

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.

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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