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OpenTrials
Completed

NCT Number: NCT04453254

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

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.

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Key information

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole Food Meal

Other

Isocaloric/ macronutrient whole food meal

Supplement Food Meal

Other

Isocaloric/ macronutrient supplement food meal

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Skidmore College

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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