Development of Melt Organic Baking Fat for Reducing Child Obesity

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT02346994

Collaborator

United States Department of Agriculture (USDA) (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Pediatric Obesity	Dietary Supplement: Melt Test Blend 3.2 Dietary Supplement: Corn Oil	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Development and Expansion of Melt Organic Baking Fat for Oxidative Stability and Reducing Child Obesity

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melt test blend 3.2	Dietary Supplement: Melt Test Blend 3.2 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.
Active Comparator: Corn Oil	Dietary Supplement: Corn Oil 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.

Arm

Intervention/Treatment

Experimental: Melt test blend 3.2

Dietary Supplement: Melt Test Blend 3.2

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.

Active Comparator: Corn Oil

Dietary Supplement: Corn Oil

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.

Outcome Measures

Primary Outcome Measures

Thermic effect of food [5.5 hours]
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 [5.5 hours]
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 [Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast]
Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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