Development of Melt Organic Baking Fat for Reducing Child Obesity

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.

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