Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Mayo Clinic52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Disease

Interventions

SAMeDIETARY_SUPPLEMENT

800 mg dose daily for 4 weeks.

PlaceboOTHER

2 placebo pills daily for 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Homocysteine levels pre- and post- one month of SAMe administration.

Time frame: 1 Month

Secondary Outcomes

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

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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