Effect of Creatine and L-Arginine on Endothelial Function

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Dietary Supplement: Creatine; Dietary Supplement: l-arginine; Dietary Supplement: L-arginine and creatine; Dietary Supplement: placebo, double

• Registration Number: NCT00551434
• Lead Sponsor: Boston University

Brief Summary

The study is a double blind 2x2 factorial study. Patients with coronary disease will be randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary supplement. The function of the endothelium will be tested using ultrasound before and after each treatment. These studies will help us understand why the endothelium is abnormal in patients with coronary artery disease and how L-arginine is acting on endothelial function.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Study Completion: 2005-12
• Status Verified: 2007-10
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-30
• Last Update Submitted: 2007-10-30
• Study First Posted: 2007-10-31
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Coronary artery disease

Exclusion Criteria

• Pregnancy
• Creatine use within one month of study
• L-arginine use within one month of study
• Change in dose or initiation of lipid lowering therapy, aspirin therapy, or angiotensin converting enzyme therapy within one month of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Creatine	-
2	l-arginine	-
3	L-arginine and creatine	-
4	placebo, double	-

Primary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilation	5 days

Secondary Outcome Measures

Name	Time	Method
serum arginine, creatine, creatinine, homocysteine	5 days