Development of Melt Organic Baking Fat for Reducing Child Obesity

January 30, 2017 updated by: Marie-Pierre St-Onge, Columbia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Nutrition Obesity Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thermic effect of food
Time Frame: 5.5 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appetite/satiety measures area under the curve
Time Frame: 5.5 hours
A visual analog scale and a computer program will assess different aspects of appetite and satiety in study participants.
5.5 hours
Insulin, glucose, triglycerides area under the curve
Time Frame: 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.
Fasting, and at minutes 0, 30, 45, 60, 120, and 180 after the end of breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

United States Department of Agriculture (USDA)

Investigators

  • Principal Investigator: Marie-Pierre St-Onge, Ph.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAN3253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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