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Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284011
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : January 6, 2012
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic

Study Description
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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
Heart Disease Dietary Supplement: SAMe Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Methionine

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Homocysteine levels pre- and post- one month of SAMe administration. [ Time Frame: 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. [ Time Frame: 2 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284011


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

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Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00284011    
Other Study ID Numbers: 677-04
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012
Keywords provided by Dietlind Wahner-Roedler, Mayo Clinic:
SAMe
AdoMet
Methylation
 Homocysteine
Dietary Supplement
S-Adenosyl-L-Methionine
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases