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

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.

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