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OpenTrials
Completed

NCT Number: NCT00284011

Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

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.

Completed

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAMe

Dietary Supplement

800 mg dose daily for 4 weeks.

Other names: AdoMet, S-Adenosyl-L-Methionine

Placebo

Other

2 placebo pills daily for 4 weeks.

Primary outcomes

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

    Time frame: 1 Month

Secondary outcomes

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

    Time frame: 2 Weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 31, 2006
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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