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Chromium Picolinate for the Treatment of Metabolic Syndrome

Primary Purpose

Metabolic Syndrome X, Prediabetic State, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chromium picolinate
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Chromium, Chromium picolinate, Blood Glucose, Cholesterol, Complementary Therapies

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Pennsylvania

Outcomes

Primary Outcome Measures

Increase in insulin sensitivity

Secondary Outcome Measures

Glucose effectiveness
acute insulin response to glucose
fasting triglycerides and high density lipoprotein cholesterol
free fatty acids
weight and/or body composition

Full Information

First Posted
August 5, 2005
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00128154
Brief Title
Chromium Picolinate for the Treatment of Metabolic Syndrome
Official Title
A Double-Blind Randomized Controlled Clinical Trial of Chromium Picolinate on Clinical and Biochemical Features of the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Prediabetic State, Insulin Resistance, Obesity, Metabolic Diseases
Keywords
Chromium, Chromium picolinate, Blood Glucose, Cholesterol, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chromium picolinate
Primary Outcome Measure Information:
Title
Increase in insulin sensitivity
Secondary Outcome Measure Information:
Title
Glucose effectiveness
Title
acute insulin response to glucose
Title
fasting triglycerides and high density lipoprotein cholesterol
Title
free fatty acids
Title
weight and/or body composition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayyar Iqbal, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19422140
Citation
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.
Results Reference
derived

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Chromium Picolinate for the Treatment of Metabolic Syndrome

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