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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453254
• Other study ID #: 1302-333
• Status: Completed
• Phase: N/A
• Start date: April 15, 2013
• Est. completion date: May 1, 2013

Study information

• Verified date: April 2024
• Source: Skidmore College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2013
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Weight Loss

Intervention

Other:
• Whole Food Meal
Isocaloric/ macronutrient whole food meal
• Supplement Food Meal
Isocaloric/ macronutrient supplement food meal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skidmore College

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
Secondary	Change in blood glucose	Measure the change in postprandial blood glucose compared baseline using the finger stick procedure.	Baseline line, 30, 60, 90, 120 minutes postprandial
Secondary	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.	Baseline to 120 minutes postprandial