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

This study has been completed.
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: May 28, 2013
Last verified: May 2013
  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:


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


Enrollment: 5
Study Start Date: October 2012
Study Completion Date: February 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720589

Locations
United States, New York
St. Luke's/Roosevelt Hospital
New York, New York, United States, 10025
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: May 28, 2013
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 July 24, 2014