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Supplements for Controlling Resistance to Insulin

NCT00699413 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-06-11

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • InterHealth Nutraceuticals, Inc.

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Michael I Goran, PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00699413 on ClinicalTrials.gov