Clinical trial NCT02346994: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2015-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Thermic effect of food
timeFrame: 5.5 hours
Secondary outcomes:
measure: Appetite/satiety measures area under the curve
timeFrame: 5.5 hours
measure: Insulin, glucose, triglycerides area under the curve
timeFrame: Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Nutrition Obesity Research Center
state: New York
Study officials:
affiliation: Columbia University
name: Marie-Pierre St-Onge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: