Supplements for Controlling Resistance to Insulin (SCORE)

University of Southern California

Status and phase

Terminated

Phase 4

Conditions

Obesity

Diabetes Mellitus, Type 2

Treatments

Drug: nutrition education plus inactive supplement

Drug: nutrition education plus active supplement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00699413

SCORE1

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

13 to 17 years old

Volunteers

Accepts Healthy Volunteers

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).