Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Mayo Clinic

Status: Completed

Conditions: Heart Disease

Treatments: Other: Placebo; Dietary Supplement: SAMe

Study type: Interventional

Funder types: Other

Identifiers

NCT00284011

677-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

SAMe

Active Comparator group

Description:

Two 400 mg pills.

Treatment:

Dietary Supplement: SAMe

Placebo

Placebo Comparator group

Description:

Two placebo pills (identical in appearance to SAMe).

Treatment:

Other: Placebo