Supplements for Controlling Resistance to Insulin
Condition: Obesity; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: nutrition education plus active supplement; nutrition education plus inactive supplement
Intervention description: After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes.
Active and inactive supplements will be identical in appearance and taste. Active supplements will contain 2,700 mgs/day of Super CitriMax (hydroxycitrate)and 400 µg per day of ChromeMate (niacin-bound Chromium). Supplements will be in powder and tablet form, and should be taken 30 minutes prior to each meal.; After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes.
Active and inactive supplements will be identical in appearance and taste.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate
      (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week
      period. Participants will be evaluated with regard to BMI, percent body fat, insulin
      activity, and hunger.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age

               -  All subjects will be between 13 and 17 years of age

          -  Overweight

               -  All subjects will be overweight as defined by an age & sex-specific body mass
                  index ≥ 85th percentile based on CDC BMI growth charts [US Department of Health
                  and Human Services, 2000], calculated by Epi Info Software, version 3.3.

        Exclusion Criteria:

          -  Presently taking any prescribed medication(s) or diagnosed with any syndrome or
             disease that could influence dietary intake, body composition and fat distribution, or
             insulin action or secretion.

          -  Previously diagnosed with any major illness since birth (e.g. sever intrauterine
             growth retardation, chronic birth asphyxia, cancer).

          -  Children with type 1 and/or type 2 diabetes will be excluded are referred to a
             physician.

          -  Currently involved with any dietary, exercise, or weight loss program or have been in
             the 6 months prior to participation.

          -  Unexplained weight loss or gain in the prior six months.

          -  Oral contraception use in sexually active females

          -  Children who live further than 20 miles away from the USC Health Science Campus (HSC).