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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00284011

Enrollment

Registered

2006-01-31

Start date

2005-06-30

Completion date

2006-05-31

Last updated

2012-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

SAMe, AdoMet, Methylation, Homocysteine, Dietary Supplement, S-Adenosyl-L-Methionine

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.

Interventions

DIETARY_SUPPLEMENTSAMe

800 mg dose daily for 4 weeks.

OTHERPlacebo

2 placebo pills daily for 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Women and men age 18 - 65 * Able to understand and sign a consent form

Exclusion criteria

* Smoking * Pregnant or lactating * Women actively trying to conceive * Diagnosis of panic disorder or bipolar disorder

Design outcomes

Primary

Measure	Time frame
Homocysteine levels pre- and post- one month of SAMe administration.	1 Month

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026