Chromium Picolinate for the Treatment of Metabolic Syndrome

Obesity Clinical Trial

Official title:

A Double-Blind Randomized Controlled Clinical Trial of Chromium Picolinate on Clinical and Biochemical Features of the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128154
• Other study ID #: R21 AT001147-01
• Status: Completed
• Phase: N/A
• First received: August 5, 2005
• Last updated: August 17, 2006
• Start date: January 2004
• Est. completion date: December 2005

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Chromium picolinate

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in insulin sensitivity
Secondary	Glucose effectiveness
Secondary	acute insulin response to glucose
Secondary	fasting triglycerides and high density lipoprotein cholesterol
Secondary	free fatty acids
Secondary	weight and/or body composition