Thermic Effect of Three Different Meals in Healthy Women

April 5, 2024 updated by: Skidmore College

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whole Food Meal
Whole foods meal - grilled cheese and drink meal
Whole foods meal
Experimental: Processed Food Meal
Highly processed foods - grilled cheese and drink meal
Processed food meal
Experimental: Gluten-Free and Lactose-Free Meal
Gluten-free and lactose-free foods - grilled cheese and drink meal
Gluten-free and lactose-free food meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose Response
Time Frame: Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
Change in postprandial blood glucose compared baseline
Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
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
Baseline 0 minutes, and 60, 120, 180 minutes postprandial
Heart Rate
Time Frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Measure heart rate following the resting metabolic rate test
Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Blood Pressure
Time Frame: Baseline 0 minutes, 60, 120, and 180 minutes postprandial
Measure blood pressure following the resting metabolic rate test
Baseline 0 minutes, 60, 120, and 180 minutes postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mary Hoehn, MPH, Skidmore College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2015

Primary Completion (Actual)

May 30, 2015

Study Completion (Actual)

May 30, 2015

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1502-441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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