Clinical trial NCT00128154: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome X
Prediabetic State
Insulin Resistance
Obesity
Metabolic Diseases
Keywords: Chromium
Chromium picolinate
Blood Glucose
Cholesterol
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2005-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Increase in insulin sensitivity
Secondary outcomes:
measure: Glucose effectiveness
measure: acute insulin response to glucose
measure: fasting triglycerides and high density lipoprotein cholesterol
measure: free fatty acids
measure: weight and/or body composition
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nayyar Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.