- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440826
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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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