Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Heart Disease Clinical Trial

Official title:

Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284011
• Other study ID #: 677-04
• Status: Completed
• Phase: N/A
• First received: January 30, 2006
• Last updated: January 4, 2012
• Start date: June 2005
• Est. completion date: May 2006

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease

Intervention

Dietary Supplement:
• SAMe
800 mg dose daily for 4 weeks.

Other:
• Placebo
2 placebo pills daily for 4 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Thompson MA, Bauer BA, Loehrer LL, Cha SS, Mandrekar JN, Sood A, Wahner-Roedler DL. Dietary supplement S-adenosyl-L-methionine (AdoMet) effects on plasma homocysteine levels in healthy human subjects: a double-blind, placebo-controlled, randomized clinica — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homocysteine levels pre- and post- one month of SAMe administration.		1 Month	Yes
Secondary	An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests.		2 Weeks	Yes