Development of Melt Organic Baking Fat for Reducing Child Obesity
Condition: Obesity; Overweight; Pediatric Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

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

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.
    

Intervention name(s): Melt Test Blend 3.2; Corn Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Body Weight; Obesity in Adolescence; Obesity in Childhood; Childhood Onset Obesity; Childhood Obesity; Child Obesity; Adolescent Obesity; Teenagers; Teens; Youth; Adolescents; Adolescence