Chromium Picolinate for the Treatment of Metabolic Syndrome

National Institutes of Health (NIH)

Status

Completed

Conditions

Metabolic Diseases

Prediabetic State

Insulin Resistance

Obesity

Metabolic Syndrome X

Treatments

Drug: Chromium picolinate

Study type

Interventional

Funder types

NIH

Identifiers

NCT00128154

R21 AT001147-01

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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