Supplements for Controlling Resistance to Insulin

Phase 4

Terminated

Interventions: Drug: nutrition education plus active supplement
Drug: nutrition education plus inactive supplement

Brief 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.

Detailed Description: The prevalence of obesity among youth has increased dramatically in recent years. Parallel to the increased rates of pediatric obesity, overweight children present clinically with adiposity related comorbidities such as insulin resistance and type 2 diabetes. The prevailing recommendations for overweight youth are to increase physical activity levels and limit energy intake in order to improve body composition. Currently there is little empirical evidence to support the efficacy of these recommendations. Alternatively, evidence in adults suggests that nutritional supplementation with (-) hydroxycitric acid (HCA), an organic acid found naturally in citrus fruits, and chromium may lead to favorable changes in body composition and improve glucose regulation. To date, these issues have not been tested in youth. Therefore, the purpose of the present investigation is to examine the effects of a nutritional education program combined with either HCA + chromium or placebo on measures of body composition and glucose regulation in overweight adolescents.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
1 - nutrition education plus active supplement	nutrition education plus active supplement	nutrition education plus active supplement
2 - nutrition education plus inactive supplement	nutrition education plus inactive supplement	nutrition education plus inactive supplement

Primary Outcome Measures

Name	Time	Method
Body Mass Index	measured at baseline and 12 weeks	Change in Body Mass Index measurement at baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Insulin Activity	Measured at baseline and 12 weeks	Change in insulin activity measured at baseline and 12 weeks
Percent Body Fat	Measured at baseline and 12 weeks	Change in percent body fat measured at baseline and 12 weeks
Hunger	Measured at baseline and 12 weeks	Change in hunger score using Likert scale measured at baseline and 12 weeks