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Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00284011
First received: January 30, 2006
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Heart Disease
 Dietary Supplement: SAMe
Other: Placebo

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Homocysteine levels pre- and post- one month of SAMe administration. [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: June 2005
Study Completion Date: May 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284011

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dietland Wahner-Roedler, M.D. Mayo Clinic
  More Information

Publications:

Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00284011     History of Changes
Other Study ID Numbers: 677-04
Study First Received: January 30, 2006
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
SAMe
AdoMet
Methylation
 Homocysteine
Dietary Supplement
S-Adenosyl-L-Methionine

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013