Thermic Effect of Three Different Meals in Healthy Women
Primary Purpose
Weight Loss, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole Food Meal
Processed Food Meal
Gluten-free and lactose-free
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Whole Food Meal
Processed Food Meal
Gluten-Free and Lactose-Free Meal
Arm Description
Whole foods meal - grilled cheese and drink meal
Highly processed foods - grilled cheese and drink meal
Gluten-free and lactose-free foods - grilled cheese and drink meal
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Blood Glucose Response
Change in postprandial blood glucose compared baseline
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
Heart Rate
Measure heart rate following the resting metabolic rate test
Blood Pressure
Measure blood pressure following the resting metabolic rate test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04440826
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 23, 2015 (Actual)
Primary Completion Date
May 30, 2015 (Actual)
Study Completion Date
May 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skidmore College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole Food Meal
Arm Type
Active Comparator
Arm Description
Whole foods meal - grilled cheese and drink meal
Arm Title
Processed Food Meal
Arm Type
Experimental
Arm Description
Highly processed foods - grilled cheese and drink meal
Arm Title
Gluten-Free and Lactose-Free Meal
Arm Type
Experimental
Arm Description
Gluten-free and lactose-free foods - grilled cheese and drink meal
Intervention Type
Other
Intervention Name(s)
Whole Food Meal
Intervention Description
Whole foods meal
Intervention Type
Other
Intervention Name(s)
Processed Food Meal
Intervention Description
Processed food meal
Intervention Type
Other
Intervention Name(s)
Gluten-free and lactose-free
Intervention Description
Gluten-free and lactose-free food meal
Primary Outcome Measure Information:
Title
Thermic Effect of Meals (TEM) also known as Postprandial Thermogenesis
Description
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)
Time Frame
TEM; 45-60; 105-120; and 165-180 minutes after meal ingestion
Secondary Outcome Measure Information:
Title
Blood Glucose Response
Description
Change in postprandial blood glucose compared baseline
Time Frame
Baseline line 0 minutes, and 60, 120, 180 minutes postprandial
Title
Change in Hunger and Palatability Scores and Energy Level
Description
Assess change in subjective hunger, fullness, satiation, palatability and energy ratings using a visual analog scale ranging from 0-100 mm
Time Frame
Baseline 0 minutes, and 60, 120, 180 minutes postprandial
Title
Heart Rate
Description
Measure heart rate following the resting metabolic rate test
Time Frame
Baseline 0 minutes
Title
Blood Pressure
Description
Measure blood pressure following the resting metabolic rate test
Time Frame
Baseline 0 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Hoehn, MPH
Organizational Affiliation
Skidmore College
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thermic Effect of Three Different Meals in Healthy Women
We'll reach out to this number within 24 hrs