Status:
TERMINATED
Supplements for Controlling Resistance to Insulin
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
InterHealth Nutraceuticals, Inc.
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
13-17 years
Phase:
PHASE4
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. Participan...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00699413
Start Date
February 1 2008
End Date
August 1 2008
Last Update
June 11 2024
Active Locations (1)
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1
USC - Preventive Medicine
Los Angeles, California, United States, 90033