Development of Melt Organic Baking Fat for Reducing Child Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346994
• Other study ID #: AAAN3253
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: January 30, 2017
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.

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.

Other known NCT identifiers

• NCT02132377

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Nutrition Obesity Research Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5.5 hours
Secondary	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.	5.5 hours
Secondary	Insulin, glucose, triglycerides area under the curve	Blood draw and analyses will be used to measure triglycerides, glucose, and insulin.	Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast