Supplements for Controlling Resistance to Insulin

NCT00699413 | Terminated Phase 4 Results

• 1 other identifier: SCORE1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  Change in Body Mass Index measurement at baseline and 12 weeks

  measured at baseline and 12 weeks

Secondary Outcomes (3)

• Insulin Activity

  Measured at baseline and 12 weeks

• Percent Body Fat

  Measured at baseline and 12 weeks

• Hunger

  Measured at baseline and 12 weeks

Study Arms (2)

1 - nutrition education plus active supplement

ACTIVE COMPARATOR

nutrition education plus active supplement

Drug: nutrition education plus active supplement

2 - nutrition education plus inactive supplement

PLACEBO COMPARATOR

nutrition education plus inactive supplement

Drug: nutrition education plus inactive supplement

Interventions

nutrition education plus active supplement DRUG

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.

Also known as: none known

1 - nutrition education plus active supplement

nutrition education plus inactive supplement DRUG

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.

Also known as: none known

2 - nutrition education plus inactive supplement

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern California: lead
• InterHealth Nutraceuticals, Inc.: collaborator

Study Sites (1)

USC - Preventive Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Michael Goran
• Organization: USC

goran@usc.edu

323.442.3027

Study Officials

• Michael I Goran, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: June 11, 2024
• Results First Posted: May 11, 2017

Record last verified: 2024-05

Locations

US (1)