Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects|
- Homocysteine levels pre- and post- one month of SAMe administration. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]
- An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests. [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Active Comparator: SAMe
Two 400 mg pills.
Dietary Supplement: SAMe
800 mg dose daily for 4 weeks.
Placebo Comparator: Placebo
Two placebo pills (identical in appearance to SAMe).
2 placebo pills daily for 4 weeks.
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.