Chromium Picolinate for the Treatment of Metabolic Syndrome

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Chromium; Picolinic acid

Criteria

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