Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.

Official Title
-----------------
Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Melt (test oil)
* Dietary Supplement: Corn oil (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 15-18 body mass index 85% percentile or higher for age/sex weight stable Exclusion Criteria: ±5 lbs weight change in the the 3 months prior use of medications dietary allergies metabolic disorder eating disorder behavioral or psychological disorders

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melt (test oil)<br>Participants will consume a muffin containing 20 g of dietary fat provided by the test oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the test oil and their food intake at an ad libitum meal will be measured 1 hour later. | Dietary Supplement: Melt (test oil)<br> <br> |
| Active Comparator: Corn oil (control)<br>Participants will consume a muffin containing 20 g of dietary fat provided by the control oil and their energy expenditure will be measure post-prandially for 6 hours. At the end of the measurement period, participants will consume a cookie containing 10 g of fat provided by the control oil and their food intake at an ad libitum meal will be measured 1 hour later. | Dietary Supplement: Corn oil (control)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermic effect of food | Measurement of thermic effect of food over 6 hours after a meal rich in test oil and control oil. The thermic effect of food is the difference between post-prandial energy expenditure and basal energy expenditure. We will assess the difference in thermic effect of food over a 6-hour period between the test oil and the control oil. | 6 h | 
| Respiratory quotient/fat oxidation | Measurement of substrate oxidation by indirect calorimetry over 6 hours after consumption of the test oil and control oil. We will specifically calculate carbohydrate and fat oxidation rates over the 6-hour period post-prandially and compare rates of oxidation of these two substrates between the test oil and the control oil. | 6 h | 
| Food intake | Measurement of food intake at a single meal served 1 hour after a pre-load containing 8-10 g of the test oil and the control oil | single meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Measurement of glucose over 6 hours after consumption of the test oil and control oil | 6 h | 
| Feelings of appetite and satiety | Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil | 6 h | 
| Insulin | Measurement of insulin over 6 hours after consumption of the test oil and control oil | 6 hours | 
| Leptin | Measurement of leptin over 6 hours after consumption of the test oil and control oil | 6 hours | 
| Ghrelin | Measurement of ghrelin over 6 hours after consumption of the test oil and control oil | 6 hours | 
| Peptide YY | Measurement of peptide YY over 6 hours after consumption of the test oil and control oil | 6 hours | 
| Glucagon like peptide 1 | Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Dietary fat, Energy expenditure, Food intake