Supplements for Controlling Resistance to Insulin (SCORE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Diabetes Mellitus, Type 2 |
Drug: Super CitriMax and ChromeMate (in overweight adolescents) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Supplements for Controlling Resistance to Insulin |
- Body Mass Index / Weight [ Time Frame: measured at baseline and 12 weeks ] [ Designated as safety issue: No ]
- Insulin Activity [ Time Frame: Measured at baseline and 12 weeks ] [ Designated as safety issue: No ]
- Percent Body Fat [ Time Frame: Measured at baseline and 12 weeks ] [ Designated as safety issue: No ]
- Hunger [ Time Frame: Measured at baseline and 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | February 2008 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
nutrition education plus active supplement
|
Drug: Super CitriMax and ChromeMate (in overweight adolescents)
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. Other Name: none known
|
|
Placebo Comparator: 2
nutrition education plus inactive supplement
|
Drug: Super CitriMax and ChromeMate (in overweight adolescents)
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. Other Name: none known
|
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| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations| United States, California | |
| USC Institute for Prevention Research | |
| Los Angeles, California, United States, 90089 | |
| Principal Investigator: | Michael I Goran, PhD | University of Southern California |
More Information
No publications provided
| Responsible Party: | Debasis Bagchi, InterHealth Nutraceuticals |
| ClinicalTrials.gov Identifier: | NCT00699413 History of Changes |
| Other Study ID Numbers: | SCORE1 |
| Study First Received: | June 16, 2008 |
| Last Updated: | March 24, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013