Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children

Childhood Obesity Clinical Trial

— Melt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720589
• Other study ID #: 2012-33610-19482
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: May 28, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Dietary Supplement:
• Melt (test oil)

• Corn oil (control)

Locations

Country	Name	City	State
United States	St. Luke's/Roosevelt Hospital	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Prosperity Organic Foods, USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Glucose	Measurement of glucose over 6 hours after consumption of the test oil and control oil	6 h	No
Secondary	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	No
Secondary	Insulin	Measurement of insulin over 6 hours after consumption of the test oil and control oil	6 hours	No
Secondary	Leptin	Measurement of leptin over 6 hours after consumption of the test oil and control oil	6 hours	No
Secondary	Ghrelin	Measurement of ghrelin over 6 hours after consumption of the test oil and control oil	6 hours	No
Secondary	Peptide YY	Measurement of peptide YY over 6 hours after consumption of the test oil and control oil	6 hours	No
Secondary	Glucagon like peptide 1	Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil	6 hours	No