Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Not Applicable

Completed

• Conditions: Heart Disease
• Interventions: Dietary Supplement: SAMe; Other: Placebo

• Registration Number: NCT00284011
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to determine if the oral intake of the dietary supplement SAMe increases blood homocysteine levels in healthy human subjects.

Detailed Description

S-adenosyl-L-methionine (SAMe or AdoMet) is a commonly used nutritional supplement available in the United States since 1999. SAMe is metabolized to homocysteine, a known cardiovascular risk factor. No study has determined the effect exogenous SAMe administration has on the long-term levels of homocysteine in humans. As a nutritional supplement, SAMe is not regulated by the Food and Drug Administration, despite being used to treat clinical diseases such as depression and osteoarthritis.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-01-30
• Study First Submitted QC: 2006-01-30
• Study First Posted: 2006-01-31
• Primary Completion: 2006-04
• Study Completion: 2006-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAMe	SAMe	Two 400 mg pills.
Placebo	Placebo	Two placebo pills (identical in appearance to SAMe).

Primary Outcome Measures

Name	Time	Method
Homocysteine levels pre- and post- one month of SAMe administration.	1 Month

Secondary Outcome Measures

Name	Time	Method
An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests.	2 Weeks

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States