Back to resultsEffect of Dietary Fat Cooking Blend on Energy Expenditure in Children (Melt)
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melt (test oil)
Corn oil (control)
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Dietary fat, Energy expenditure, Food intake
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
Sites / Locations
- St. Luke's/Roosevelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Melt (test oil)
Corn oil (control)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Glucose
Measurement of glucose over 6 hours after consumption of the test oil and control oil
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
Insulin
Measurement of insulin over 6 hours after consumption of the test oil and control oil
Leptin
Measurement of leptin over 6 hours after consumption of the test oil and control oil
Ghrelin
Measurement of ghrelin over 6 hours after consumption of the test oil and control oil
Peptide YY
Measurement of peptide YY over 6 hours after consumption of the test oil and control oil
Glucagon like peptide 1
Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil
Full Information
NCT ID
NCT01720589
First Posted
October 17, 2012
Last Updated
May 28, 2013
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Prosperity Organic Foods, USDA Beltsville Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01720589
Brief Title
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
Acronym
Melt
Official Title
Development of Rich & Creamy Melt® Organic Cooking Blend for Oxidative Stability and Reducing Childhood Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Prosperity Organic Foods, USDA Beltsville Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Obesity, Dietary fat, Energy expenditure, Food intake
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melt (test oil)
Arm Type
Experimental
Arm Description
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.
Arm Title
Corn oil (control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melt (test oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn oil (control)
Primary Outcome Measure Information:
Title
Thermic effect of food
Description
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.
Time Frame
6 h
Title
Respiratory quotient/fat oxidation
Description
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.
Time Frame
6 h
Title
Food intake
Description
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
Time Frame
single meal
Secondary Outcome Measure Information:
Title
Glucose
Description
Measurement of glucose over 6 hours after consumption of the test oil and control oil
Time Frame
6 h
Title
Feelings of appetite and satiety
Description
Measurement of feelings of appetite and satiety by visual analog scales over 6 hours after consumption of the test oil and control oil
Time Frame
6 h
Title
Insulin
Description
Measurement of insulin over 6 hours after consumption of the test oil and control oil
Time Frame
6 hours
Title
Leptin
Description
Measurement of leptin over 6 hours after consumption of the test oil and control oil
Time Frame
6 hours
Title
Ghrelin
Description
Measurement of ghrelin over 6 hours after consumption of the test oil and control oil
Time Frame
6 hours
Title
Peptide YY
Description
Measurement of peptide YY over 6 hours after consumption of the test oil and control oil
Time Frame
6 hours
Title
Glucagon like peptide 1
Description
Measurement of glucagon like peptide 1 over 6 hours after consumption of the test oil and control oil
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, Ph.D
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cygnia Rapp
Organizational Affiliation
Prosperity Organic Foods
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's/Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
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