Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284011
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2006-01-30
Brief Title:
Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None