Text Size

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

This study is currently recruiting participants.
Verified October 2012 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Collaborators:
Prosperity Organic Foods
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Marie-Pierre St-Onge, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01720589
First received: October 17, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Childhood Obesity
 Dietary Supplement: Melt (test oil)
Dietary Supplement: Corn oil (control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity

Resource links provided by NLM:

Drug Information available for: Corn oil
U.S. FDA Resources

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Thermic effect of food [ Time Frame: 6 h ] [ Designated as safety issue: No ]
    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.

  • Respiratory quotient/fat oxidation [ Time Frame: 6 h ] [ Designated as safety issue: No ]
    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.

  • Food intake [ Time Frame: single meal ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Glucose [ Time Frame: 6 h ] [ Designated as safety issue: No ]
    Measurement of glucose over 6 hours after consumption of the test oil and control oil

  • Feelings of appetite and satiety [ Time Frame: 6 h ] [ Designated as safety issue: No ]
    Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil

  • Insulin [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Measurement of insulin over 6 hours after consumption of the test oil and control oil

  • Leptin [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Measurement of leptin over 6 hours after consumption of the test oil and control oil

  • Ghrelin [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Measurement of ghrelin over 6 hours after consumption of the test oil and control oil

  • Peptide YY [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Measurement of peptide YY over 6 hours after consumption of the test oil and control oil

  • Glucagon like peptide 1 [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil


Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720589

Contacts
Contact: Julie Shlisky, Ph.D 2125234603 jshlisky@chpnet.org

Locations
United States, New York
St. Luke's/Roosevelt Hospital Recruiting
New York, New York, United States, 10025
Principal Investigator: Marie-Pierre St-Onge, Ph.D            
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Prosperity Organic Foods
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Marie-Pierre St-Onge, Ph.D St. Luke's-Roosevelt Hospital Center
Principal Investigator: Cygnia Rapp Prosperity Organic Foods
  More Information

No publications provided

Responsible Party: Marie-Pierre St-Onge, Research Associate, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01720589     History of Changes
Other Study ID Numbers: 2012-33610-19482
Study First Received: October 17, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Obesity
Dietary fat
Energy expenditure
Food intake

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013