SCORE: Supplements for Controlling Resistance to Insulin

• Sponsor: University of Southern California (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00699413
• Collaborator: InterHealth Nutraceuticals, Inc. (Industry)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Diabetes Mellitus, Type 2	Drug: nutrition education plus active supplement; Drug: nutrition education plus inactive supplement	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Supplements for Controlling Resistance to Insulin
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 - nutrition education plus active supplement nutrition education plus active supplement	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.; Other Names: none known
Placebo Comparator: 2 - nutrition education plus inactive supplement nutrition education plus inactive supplement	Drug: 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.; Other Names: none known

Outcome Measures

Primary Outcome Measures

1. Body Mass Index [measured at baseline and 12 weeks]

   Change in Body Mass Index measurement at baseline and 12 weeks

Secondary Outcome Measures

1. Insulin Activity [Measured at baseline and 12 weeks]

   Change in insulin activity measured at baseline and 12 weeks

2. Percent Body Fat [Measured at baseline and 12 weeks]

   Change in percent body fat measured at baseline and 12 weeks

3. Hunger [Measured at baseline and 12 weeks]

   Change in hunger score measured at baseline and 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 17 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	USC - Preventive Medicine	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California
• InterHealth Nutraceuticals, Inc.

Investigators

• Principal Investigator: Michael I Goran, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael I. Goran, Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT00699413
• Other Study ID Numbers: SCORE1
• First Posted: Jun 18, 2008
• Last Update Posted: Jun 25, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	nutrition education plus active supplement	nutrition education plus inactive supplement
Period Title: Overall Study
STARTED	4	4
COMPLETED	0	0
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Intervention Arm	Control Arm	Total
Arm/Group Description	nutrition education plus active supplement	nutrition education plus inactive supplement	Total of all reporting groups
Overall Participants	4	2	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15 (1.41)	14 (1)	14.6 (1.37)
Age, Customized (participants) [Number]
<=18 years	4 100%	2 100%	6 100%
Sex: Female, Male (Count of Participants)
Female	2 50%	2 100%	4 66.7%
Male	2 50%	0 0%	2 33.3%
Region of Enrollment (participants) [Number]
United States	4 100%	2 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Body Mass Index
Description	Change in Body Mass Index measurement at baseline and 12 weeks
Time Frame	measured at baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected. Previously reported data were incorrect and do not reflect a change in BMI from baseline to 12 weeks. Only basic demographic information was collected at baseline and no outcome measures were captured. The study was terminated prior to the 12 week intervention end and no data were collected at the second time point.

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	nutrition education plus active supplement	nutrition education plus inactive supplement
Measure Participants	0	0

2. Secondary Outcome

Title	Insulin Activity
Description	Change in insulin activity measured at baseline and 12 weeks
Time Frame	Measured at baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	nutrition education plus active supplement	nutrition education plus inactive supplement
Measure Participants	0	0

3. Secondary Outcome

Title	Percent Body Fat
Description	Change in percent body fat measured at baseline and 12 weeks
Time Frame	Measured at baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	nutrition education plus active supplement	nutrition education plus inactive supplement
Measure Participants	0	0

4. Secondary Outcome

Title	Hunger
Description	Change in hunger score measured at baseline and 12 weeks
Time Frame	Measured at baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	nutrition education plus active supplement	nutrition education plus inactive supplement
Measure Participants	0	0

Adverse Events

Arm/Group Title	Intervention Arm		Control Arm
Arm/Group Description	nutrition education plus active supplement		nutrition education plus inactive supplement
All Cause Mortality
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.