Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine

Baylor Research Institute27 enrolled

Overview

The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration effects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia through the following specific aims: Specific Aim 1 - To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine levels in subjects with mild to moderate hyperhomocysteinemia. Specific Aim 2 - To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia. Specific Aim 3 - To determine the effect of oral SAMe (1200 mg/day) on plasma levels pf asymmetric dimethylarginine (ADMA) in subjects with mild to moderate hyperhomocysteinemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Hyperhomocysteinemia

Interventions

S-adenosylmethionineDIETARY_SUPPLEMENT

1200 mg daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age and older * Must have a serum homocysteine value greater than or equal to 14 μmol/L * Stable weight 3 months prior to study participation Exclusion Criteria: * Subjects with a BMI greater than 35 or less than 18 * Currently taking B 100 or other high-dose B vitamin supplements within the past 12 months * Taken methionine or SAMe supplements within the past 3 months

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine (tHcy) and asymmetric dimethylagrinine (ADMA) levels in subjects with mild to moderate hyperhomocysteinemia.

Time frame: 6 weeks

Secondary Outcomes

To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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