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Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00284011
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
11
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: SAMe
  • Other: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Apr 1, 2006
Actual Study Completion Date :
May 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SAMe

Two 400 mg pills.

Dietary Supplement: SAMe
800 mg dose daily for 4 weeks.
Other Names:
  • AdoMet
  • S-Adenosyl-L-Methionine

    		•
    Placebo Comparator: Placebo

    Two placebo pills (identical in appearance to SAMe).

    Other: Placebo
    2 placebo pills daily for 4 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Homocysteine levels pre- and post- one month of SAMe administration. [1 Month]

    Secondary Outcome Measures

    1. An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests. [2 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Dietland Wahner-Roedler, M.D., Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00284011
    Other Study ID Numbers:
    • 677-04
    First Posted:
    Jan 31, 2006
    Last Update Posted:
    Jan 6, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
    SAMe
    AdoMet
    Methylation
    Homocysteine
    Dietary Supplement
    S-Adenosyl-L-Methionine
    Additional relevant MeSH terms:
    Heart Diseases

    Study Results

    No Results Posted as of Jan 6, 2012