Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

NCT ID: NCT00284011

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-05-31

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.

Conditions

Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAMe

Two 400 mg pills.

Group Type: ACTIVE_COMPARATOR

SAMe

Intervention Type: DIETARY_SUPPLEMENT

800 mg dose daily for 4 weeks.

Placebo

Two placebo pills (identical in appearance to SAMe).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

2 placebo pills daily for 4 weeks.

Interventions

SAMe

800 mg dose daily for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2 placebo pills daily for 4 weeks.

Intervention Type: OTHER

Other Intervention Names

AdoMet; S-Adenosyl-L-Methionine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Dietlind Wahner-Roedler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dietland Wahner-Roedler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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 clinical trial. J Altern Complement Med. 2009 May;15(5):523-9. doi: 10.1089/acm.2008.0402.

Reference Type: RESULT

PMID: 19422296 (View on PubMed)

Other Identifiers

677-04

Identifier Type: -

Identifier Source: org_study_id