Expired Study
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New York, New York 10032


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT02346994


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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