Thermic Effect of Three Different Meals in Healthy Women

Study Overview
=================
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.

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

Conditions
-----------------
Weight Loss, Obesity

Intervention / Treatment
-----------------
* Other: Whole Food Meal
* Other: Processed Food Meal
* Other: Gluten-free and lactose-free


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose Response | 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 | 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 | Measure heart rate following the resting metabolic rate test | Baseline 0 minutes | 
| Blood Pressure | Measure blood pressure following the resting metabolic rate test | Baseline 0 minutes |