Supplements for Controlling Resistance to Insulin - Full Text View

Sponsors and Collaborators:	University of Southern California InterHealth Nutraceuticals Incorporated
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00699413

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Supplements for Controlling Resistance to Insulin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Dietary Supplements Obesity Obesity in Children

Drug Information available for: Insulin

U.S. FDA Resources

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
1: Active Comparator 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.
2: Placebo Comparator 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Placebo Comparator

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.

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

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:	InterHealth Nutraceuticals ( Debasis Bagchi )
Study ID Numbers:	SCORE1
Study First Received:	June 16, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00699413 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Obesity
Niacinamide
Metabolic Diseases
Chromium
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Nicotinamide
Body Weight
Nicotinic Acids

Signs and Symptoms
Vitamin B3
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Nicotinic Acid
Glucose Metabolism Disorders
Niacin
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 28, 2009