Thermic Effect of Three Different Meals in Healthy Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440826
• Other study ID #: 1502-441
• Status: Completed
• Phase: N/A
• Start date: February 23, 2015
• Est. completion date: May 30, 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 30, 2015
• Est. primary completion date: May 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Whole Food Meal
Whole foods meal
• Processed Food Meal
Processed food meal
• Gluten-free and lactose-free
Gluten-free and lactose-free food meal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skidmore College

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. 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)	TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
Secondary	Blood Glucose Response	Change in postprandial blood glucose compared baseline	Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
Secondary	Change in Hunger and Palatability Scores and Energy Level	Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm	Baseline 0 minutes, and 60, 120, 180 minutes postprandial
Secondary	Heart Rate	Measure heart rate following the resting metabolic rate test	Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Secondary	Blood Pressure	Measure blood pressure following the resting metabolic rate test	Baseline 0 minutes, 60, 120, and 180 minutes postprandial