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OpenTrials
Completed

NCT Number: NCT04440826

Thermic Effect of Three Different Meals in Healthy Women

This study will investigate the acute effect of three isocaloric meals varying in level of food processing, including a whole foods, gluten-free, and highly processed meal on energy metabolism and blood glucose in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals.

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Key information

About this study

A shift towards a diet containing large quantities of highly processed foods is believed to be a major contributor to the trends in obesity. The degree of processing of foods often affects the nutritional content of the constituents. A reduction in macromolecular complexity allows for an increased rate of digestion, meaning that the body does not have to work as hard to metabolize high processed food products. Thus, the purpose of this study is to investigate the effect on energy metabolism and blood glucose after the consumption of an unrefined, whole foods meal versus two highly processed food meals, including a common Western style meal and gluten-free meal in 8-12 young adult, normal weight females. A secondary aim of this proposed study is to compare palatability, satiety, and perceived energy ratings among highly processed, unrefined, and gluten-free unrefined isocaloric meals. It is hypothesized that an unrefined meal will induce a greater postprandial thermogenic response and a smaller blood glucose response than a highly processed or gluten-free meal. Additionally, it is hypothesized that a highly processed foods meal will be considered more palatable than an unrefined or gluten-free meal.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy females between the ages of 18 and 24 years that have BMIs that fall in the range of 18.5 kg/m2 to 28 kg/m2.

Exclusion criteria

  • Those with a history of celiac disease or other food allergies, metabolic disease or heart disease.

Treatment and study plan

Whole Food Meal

Other

Whole foods meal

Processed Food Meal

Other

Processed food meal

Gluten-free and lactose-free

Other

Gluten-free and lactose-free food meal

Primary outcomes

  1. Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis

    Time frame: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion

    The total amount of calories burned after each meal will be measured using indirect calorimetry with the ventilated hood technique. Specifically, the thermic effect of each meal will be measured for a total of three hours at 45 minute intervals for 15 minutes at a time (45-60; 105-120; and 165-180 minutes)

Secondary outcomes

  1. Blood Glucose Response

    Time frame: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial

    Change in postprandial blood glucose compared baseline

  2. Change in Hunger and Palatability Scores and Energy Level

    Time frame: Baseline 0 minutes, and 60, 120, 180 minutes postprandial

    Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm

  3. Heart Rate

    Time frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial

    Measure heart rate following the resting metabolic rate test

  4. Blood Pressure

    Time frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial

    Measure blood pressure following the resting metabolic rate test

Sponsors and collaborators

Lead sponsor

Skidmore College

Other

Registry information

Official study title

Dietary Induced Thermogenic Differences After Consumption of an Unrefined Meal, a Gluten-free Meal, and a Highly Processed Meal

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 22, 2020
Registry last updated
Apr 9, 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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