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Chromium Picolinate for the Treatment of Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128154
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Prediabetic State Insulin Resistance Obesity Metabolic Diseases Drug: Chromium picolinate Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Controlled Clinical Trial of Chromium Picolinate on Clinical and Biochemical Features of the Metabolic Syndrome
Study Start Date : January 2004
Study Completion Date : December 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Increase in insulin sensitivity

Secondary Outcome Measures :
  1. Glucose effectiveness
  2. acute insulin response to glucose
  3. fasting triglycerides and high density lipoprotein cholesterol
  4. free fatty acids
  5. weight and/or body composition

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128154


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Nayyar Iqbal, MD University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00128154    
Other Study ID Numbers: R21 AT001147-01
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Chromium
Chromium picolinate
Blood Glucose
Cholesterol
Complementary Therapies
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Metabolic Diseases
Prediabetic State
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Diabetes Mellitus
 Endocrine System Diseases
Chromium
Picolinic acid
Trace Elements
Micronutrients
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action