Supplements for Controlling Resistance to Insulin

Obesity Clinical Trial

— SCORE  

Official title:

Supplements for Controlling Resistance to Insulin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00699413
• Other study ID #: SCORE1
• Status: Terminated
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: August 2008

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Drug:
• nutrition education plus active supplement
After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes. Active and inactive supplements will be identical in appearance and taste. Active supplements will contain 2,700 mgs/day of Super CitriMax (hydroxycitrate)and 400 µg per day of ChromeMate (niacin-bound Chromium). Supplements will be in powder and tablet form, and should be taken 30 minutes prior to each meal.
• nutrition education plus inactive supplement
After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes. Active and inactive supplements will be identical in appearance and taste.

Locations

Country	Name	City	State
United States	USC - Preventive Medicine	Los Angeles	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index	Change in Body Mass Index measurement at baseline and 12 weeks	measured at baseline and 12 weeks
Secondary	Insulin Activity	Change in insulin activity measured at baseline and 12 weeks	Measured at baseline and 12 weeks
Secondary	Percent Body Fat	Change in percent body fat measured at baseline and 12 weeks	Measured at baseline and 12 weeks
Secondary	Hunger	Change in hunger score using Likert scale measured at baseline and 12 weeks	Measured at baseline and 12 weeks