Chromium Picolinate for the Treatment of Metabolic Syndrome
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether chromium supplements can reduce symptoms of metabolic syndrome, a collection of symptoms that increase one's risk for developing heart disease, stroke, and diabetes.
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome X Prediabetic State Insulin Resistance Obesity Metabolic Diseases |
Drug: Chromium picolinate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind Randomized Controlled Clinical Trial of Chromium Picolinate on Clinical and Biochemical Features of the Metabolic Syndrome |
- Increase in insulin sensitivity
- Glucose effectiveness
- acute insulin response to glucose
- fasting triglycerides and high density lipoprotein cholesterol
- free fatty acids
- weight and/or body composition
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2005 |
Metabolic syndrome is a serious condition that may lead to a number of life-threatening diseases. A reduction in the symptoms of metabolic syndrome could result in decreased morbidity and health care costs and increased quality of life.
Chromium is an essential mineral that is used in the breakdown of fats, protein, and carbohydrates. The cholesterol-lowering and blood sugar-stabilizing properties of chromium make the supplement a strong candidate for reducing the symptoms of metabolic syndrome. This study will determine whether chromium supplements can reduce symptoms of metabolic syndrome in abdominally obese individuals.
Participants will be randomly assigned to receive either chromium supplements or placebo daily for 16 weeks. Participants will have study visits at study start and at Months 2 and 4. A follow-up visit will occur 5 months after the end of the intervention period. Blood tests, urine tests, and nail clippings will be used to assess lipoprotein cholesterol, insulin response to glucose, lean body mass, blood pressure, oxidative stress, and chromium levels in participants.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet at least two of the following criteria for diagnosis of metabolic syndrome: 1) systolic blood pressure higher than 130 mmHg or diastolic blood pressure higher than 85 mmHg in untreated patients OR use of more than one approved antihypertensive agent; 2) fasting glucose higher than 110 mg/dL; 3) fasting triglycerides higher than 150 mg/dL; 4) high density lipoprotein (HDL) less than 40 mg/dL for men and less than 50 mg/dL for women
- Abdominal obesity defined by a waist circumference higher than 40 inches for men and 35 inches for women
Exclusion Criteria:
- Type 1 or 2 diabetes mellitus
- Use of antihyperglycemic or insulin sensitizing medication within 3 months prior to study entry
- Uncontrolled hypertension
- Triglycerides higher than 800 mg/dL
- Low density lipoprotein (LDL) cholesterol higher than 190 mg/dL
- History of renal insufficiency
- History of liver disease or abnormal liver function tests (higher than 3x upper limit normal)
- History of atherosclerotic cardiovascular disease
- History of congestive heart failure
- Cancer within 5 years prior to study entry. Participants with a history of skin cancer are not excluded.
- Surgery within 30 days prior to study entry
- Use of niacin within 6 weeks prior to study entry
- Use of fibrates within 12 weeks prior to study entry
- History of alcohol or drug abuse
- Participation in an investigational drug study within 6 weeks prior to study entry
- Any major active rheumatologic, pulmonary, or dermatologic disease, or inflammatory condition
- Unstable medical or psychological condition that would interfere with the study
- Use of any chromium-containing dietary supplement within 3 months prior to study entry
- Allergy or sensitivity to chromium, picolinic acid, or chromium picolinate
- Use of beta blockers, corticosteroids, androgens, anticoagulants, and antiarrhythmics within 3 months prior to study entry
- Use of dietary supplements within 30 days prior to study entry. Participants who use multivitamins, calcium, vitamin D, or (non-niacin) B vitamins are not excluded.
- Pregnancy or breastfeeding
Contacts and Locations More Information
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00128154 History of Changes |
| Other Study ID Numbers: | R21 AT001147-01 |
| Study First Received: | August 5, 2005 |
| Last Updated: | August 17, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Chromium Chromium picolinate Blood Glucose Cholesterol Complementary Therapies |
Additional relevant MeSH terms:
|
Insulin Resistance Metabolic Diseases Obesity Prediabetic State Metabolic Syndrome X Hyperinsulinism Glucose Metabolism Disorders Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus Endocrine System Diseases Chromium Picolinic acid Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013