Development of Melt Organic Baking Fat for Reducing Child Obesity
Primary Purpose
Obesity, Overweight, Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melt Test Blend 3.2
Corn Oil
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Body Weight, Obesity in Adolescence, Obesity in Childhood, Childhood Onset Obesity, Childhood Obesity, Child Obesity, Adolescent Obesity, Teenagers, Teens, Youth, Adolescents, Adolescence
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
- Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
Exclusion Criteria:
- Any endocrine disorder, including type 1 diabetes
- Weight loss attempted in past 3 months
- Currently using medication (prescription or over-the-counter) that could impact study outcomes
- Asthma
- Anemia
- Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
- Use of (current or in the past 4 weeks) any investigational medications or devices
- Allergy/sensitivity to wheat, milk, eggs, nuts
Sites / Locations
- New York Nutrition Obesity Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Melt test blend 3.2
Corn Oil
Arm Description
Outcomes
Primary Outcome Measures
Thermic effect of food
An indirect calorimetry cart will measure energy expenditure for approximately 40 minutes out of each hour for 5 hours after breakfast.
Secondary Outcome Measures
Appetite/satiety measures area under the curve
A visual analog scale and a computer program will assess different aspects of appetite and satiety in study participants.
Insulin, glucose, triglycerides area under the curve
Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.
Full Information
NCT ID
NCT02346994
First Posted
January 16, 2015
Last Updated
January 30, 2017
Sponsor
Columbia University
Collaborators
United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT02346994
Brief Title
Development of Melt Organic Baking Fat for Reducing Child Obesity
Official Title
Development and Expansion of Melt Organic Baking Fat for Oxidative Stability and Reducing Child Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
United States Department of Agriculture (USDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.
Detailed Description
The overall objectives of this study are to determine whether a Melt Organic baking blend can alter energy balance towards a negative energy balance by enhancing thermic effect of food and improving feelings of satiety relative to a control, corn oil, in overweight and obese adolescents.
This study will employ a 2-arm, double-blind, randomized, crossover design. Each arm will consist of one test day and will differ in the type of oil incorporated in the test breakfast: test blend 3.2 or corn oil. Oil sequence will be randomized. Each test day will follow the same protocol and will be separated by at least two weeks for boys or 4 weeks for girls to ensure that testing occurs during the same phase of their menstrual cycle for each test day.
Participants will arrive at the testing center after an overnight 12-h fast. Upon arrival, body weight will be taken and a catheter will be inserted in an antecubital vein. The participant will then rest for 30 minutes, after which resting metabolic rate (RMR) will be measured using an indirect calorimetry cart. RMR will be measured over a 45-min period. At the end of the RMR measurement, a fasting blood sample will be obtained, and the participant will be given a standard breakfast (containing 20 g of fat from either test blend 3.2 or corn oil) to consume over a 10-min period. The fat in the breakfast will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal and the rest of the energy will be provided in the form of fat free yogurt, up to 140 kcal, and applesauce.
Following breakfast, postprandial energy expenditure will be assessed every hour using the indirect calorimetry cart. At each hour of this 5-h period, participants will fill out a visual analog scale to assess their feelings of appetite and satiety and will perform a computer task assessing prospective food intake. Immediately after breakfast, and at 30, 45, 60, 120, and 180 minutes after breakfast, a blood sample will be drawn from the catheter for metabolite and hormone measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Pediatric Obesity
Keywords
Body Weight, Obesity in Adolescence, Obesity in Childhood, Childhood Onset Obesity, Childhood Obesity, Child Obesity, Adolescent Obesity, Teenagers, Teens, Youth, Adolescents, Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melt test blend 3.2
Arm Type
Experimental
Arm Title
Corn Oil
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Melt Test Blend 3.2
Intervention Description
Participant will be given a standard breakfast (containing 20 g of fat from test blend 3.2) to consume over a 10-min period. Test blend 3.2 will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn Oil
Intervention Description
Participant will be given a standard breakfast (containing 20 g of fat from corn oil) to consume over a 10-min period. Corn oil will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.
Primary Outcome Measure Information:
Title
Thermic effect of food
Description
An indirect calorimetry cart will measure energy expenditure for approximately 40 minutes out of each hour for 5 hours after breakfast.
Time Frame
5.5 hours
Secondary Outcome Measure Information:
Title
Appetite/satiety measures area under the curve
Description
A visual analog scale and a computer program will assess different aspects of appetite and satiety in study participants.
Time Frame
5.5 hours
Title
Insulin, glucose, triglycerides area under the curve
Description
Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.
Time Frame
Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast
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:
Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
Exclusion Criteria:
Any endocrine disorder, including type 1 diabetes
Weight loss attempted in past 3 months
Currently using medication (prescription or over-the-counter) that could impact study outcomes
Asthma
Anemia
Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
Use of (current or in the past 4 weeks) any investigational medications or devices
Allergy/sensitivity to wheat, milk, eggs, nuts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Pierre St-Onge, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Nutrition Obesity Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Development of Melt Organic Baking Fat for Reducing Child Obesity
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