Clinical trial NCT00699413: Supplements for Controlling Resistance to Insulin
Official title: Supplements for Controlling Resistance to Insulin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obesity
Diabetes Mellitus, Type 2
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: InterHealth Nutraceuticals, Inc.
First posted: 2008-06-18
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Body Mass Index
timeFrame: measured at baseline and 12 weeks
Secondary outcomes:
measure: Insulin Activity
timeFrame: Measured at baseline and 12 weeks
measure: Percent Body Fat
timeFrame: Measured at baseline and 12 weeks
measure: Hunger
timeFrame: Measured at baseline and 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC - Preventive Medicine
state: California
Study officials:
affiliation: University of Southern California
name: Michael I Goran, PhD
role: PRINCIPAL_INVESTIGATOR
References: