Clinical trial NCT04440826: Thermic Effect of Three Different Meals in Healthy Women
Official title: Dietary Induced Thermogenic Differences After Consumption of an Unrefined Meal, a Gluten-free Meal, and a Highly Processed Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Lead sponsor: Skidmore College
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis
timeFrame: TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
Secondary outcomes:
measure: Blood Glucose Response
timeFrame: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
measure: Change in Hunger and Palatability Scores and Energy Level
timeFrame: Baseline 0 minutes, and 60, 120, 180 minutes postprandial
measure: Heart Rate
timeFrame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
measure: Blood Pressure
timeFrame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Other outcomes:
Locations:
Study officials:
affiliation: Skidmore College
name: Mary Hoehn, MPH
role: STUDY_CHAIR
References: