NCT00284011

Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SAMe	800 mg dose daily for 4 weeks.
OTHER	Placebo	2 placebo pills daily for 4 weeks.

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-04-01
• Completion: 2006-05-01
• First posted: 2006-01-31
• Last updated: 2012-01-06

Locations

1 site across 1 country: United States