Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children (Melt)

May 28, 2013 updated by: Marie-Pierre St-Onge, St. Luke's-Roosevelt Hospital Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's/Roosevelt Hospital

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

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melt (test oil)
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)
Active Comparator: Corn oil (control)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thermic effect of food
Time Frame: 6 h
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
Time Frame: 6 h
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
Time Frame: single meal
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
Time Frame: 6 h
Measurement of glucose over 6 hours after consumption of the test oil and control oil
6 h
Feelings of appetite and satiety
Time Frame: 6 h
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
Time Frame: 6 hours
Measurement of insulin over 6 hours after consumption of the test oil and control oil
6 hours
Leptin
Time Frame: 6 hours
Measurement of leptin over 6 hours after consumption of the test oil and control oil
6 hours
Ghrelin
Time Frame: 6 hours
Measurement of ghrelin over 6 hours after consumption of the test oil and control oil
6 hours
Peptide YY
Time Frame: 6 hours
Measurement of peptide YY over 6 hours after consumption of the test oil and control oil
6 hours
Glucagon like peptide 1
Time Frame: 6 hours
Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

USDA Beltsville Human Nutrition Research Center
Prosperity Organic Foods

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, Ph.D, St. Luke's-Roosevelt Hospital Center
  • Principal Investigator: Cygnia Rapp, Prosperity Organic Foods

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

October 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-33610-19482

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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