Clinical trial NCT04453254: The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
Official title: The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Skidmore College
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thermic effect of meals (TEM) also known as postprandial thermogenesis
timeFrame: Baseline line, 15-30, 45-60, 75-90 105-120 minutes postprandial
Secondary outcomes:
measure: Change in blood glucose
timeFrame: Baseline line, 30, 60, 90, 120 minutes postprandial
measure: Change in self-reported feelings of hunger, fullness, satiation
timeFrame: Baseline to 120 minutes postprandial
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.