Supplements for Controlling Resistance to Insulin

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southern California
• Collaborator: InterHealth Nutraceuticals, Inc.

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).