Development of Melt Organic Baking Fat for Reducing Child Obesity
NCT ID: NCT02346994
Last Updated: 2017-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2013-01-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Melt test blend 3.2
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Weight stable (+/- 2.5 kg) for at least 3 months prior to screening
Exclusion Criteria
* 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
15 Years
18 Years
ALL
Yes
Sponsors
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United States Department of Agriculture (USDA)
FED
Columbia University
OTHER
Responsible Party
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Marie-Pierre St-Onge
Assistant Professor
Principal Investigators
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Marie-Pierre St-Onge, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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New York Nutrition Obesity Research Center
New York, New York, United States
Countries
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Other Identifiers
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AAAN3253
Identifier Type: -
Identifier Source: org_study_id
NCT02132377
Identifier Type: -
Identifier Source: nct_alias
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