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Supplements for Controlling Resistance to Insulin (SCORE)

Primary Purpose

Obesity, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nutrition education plus active supplement
nutrition education plus inactive supplement
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • USC - Preventive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 - nutrition education plus active supplement

2 - nutrition education plus inactive supplement

Arm Description

nutrition education plus active supplement

nutrition education plus inactive supplement

Outcomes

Primary Outcome Measures

Body Mass Index
Change in Body Mass Index measurement at baseline and 12 weeks

Secondary Outcome Measures

Insulin Activity
Change in insulin activity measured at baseline and 12 weeks
Percent Body Fat
Change in percent body fat measured at baseline and 12 weeks
Hunger
Change in hunger score measured at baseline and 12 weeks

Full Information

First Posted
June 16, 2008
Last Updated
May 31, 2019
Sponsor
University of Southern California
Collaborators
InterHealth Nutraceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00699413
Brief Title
Supplements for Controlling Resistance to Insulin
Acronym
SCORE
Official Title
Supplements for Controlling Resistance to Insulin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decided to withdraw from study.
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
InterHealth Nutraceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - nutrition education plus active supplement
Arm Type
Active Comparator
Arm Description
nutrition education plus active supplement
Arm Title
2 - nutrition education plus inactive supplement
Arm Type
Placebo Comparator
Arm Description
nutrition education plus inactive supplement
Intervention Type
Drug
Intervention Name(s)
nutrition education plus active supplement
Other Intervention Name(s)
none known
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
nutrition education plus inactive supplement
Other Intervention Name(s)
none known
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Change in Body Mass Index measurement at baseline and 12 weeks
Time Frame
measured at baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Insulin Activity
Description
Change in insulin activity measured at baseline and 12 weeks
Time Frame
Measured at baseline and 12 weeks
Title
Percent Body Fat
Description
Change in percent body fat measured at baseline and 12 weeks
Time Frame
Measured at baseline and 12 weeks
Title
Hunger
Description
Change in hunger score measured at baseline and 12 weeks
Time Frame
Measured at baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael I Goran, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC - Preventive Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Supplements for Controlling Resistance to Insulin

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