Supplements for Controlling Resistance to Insulin (SCORE)

This study has been terminated.
(Sponsor decided to withdraw from study.)
Sponsor:
Collaborator:
InterHealth Nutraceuticals Incorporated
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00699413
First received: June 16, 2008
Last updated: March 24, 2009
Last verified: June 2008
  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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Body Mass Index / Weight [ Time Frame: measured at baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699413

Locations
United States, California
USC Institute for Prevention Research
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
InterHealth Nutraceuticals Incorporated
Investigators
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 July 24, 2014