Chromium Picolinate for the Treatment of Metabolic Syndrome

NCT ID: NCT00128154

Last Updated: 2006-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-12-31

Brief 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.

Detailed 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.

Conditions

Metabolic Syndrome X; Prediabetic State; Insulin Resistance; Obesity; Metabolic Diseases

Keywords

Chromium; Chromium picolinate; Blood Glucose; Cholesterol; Complementary Therapies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Chromium picolinate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Nayyar Iqbal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Iqbal N, Cardillo S, Volger S, Bloedon LT, Anderson RA, Boston R, Szapary PO. Chromium picolinate does not improve key features of metabolic syndrome in obese nondiabetic adults. Metab Syndr Relat Disord. 2009 Apr;7(2):143-50. doi: 10.1089/met.2008.0048.

Reference Type: DERIVED

PMID: 19422140 (View on PubMed)

Other Identifiers

R21 AT001147-01

Identifier Type: -

Identifier Source: org_study_id