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Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Primary Purpose

Heart Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SAMe

Placebo

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring SAMe, AdoMet, Methylation, Homocysteine, Dietary Supplement, S-Adenosyl-L-Methionine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SAMe

Placebo

Arm Description

Two 400 mg pills.

Two placebo pills (identical in appearance to SAMe).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00284011

First Posted

January 30, 2006

Last Updated

January 4, 2012

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00284011

Brief Title

Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Disease

Keywords

SAMe, AdoMet, Methylation, Homocysteine, Dietary Supplement, S-Adenosyl-L-Methionine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAMe

Arm Type

Active Comparator

Arm Description

Two 400 mg pills.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Two placebo pills (identical in appearance to SAMe).

Intervention Type

Dietary Supplement

Intervention Name(s)

SAMe

Other Intervention Name(s)

AdoMet, S-Adenosyl-L-Methionine

Intervention Description

800 mg dose daily for 4 weeks.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

2 placebo pills daily for 4 weeks.

Primary Outcome Measure Information:

Title

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

Time Frame

1 Month

Secondary Outcome Measure Information:

Title

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

Time Frame

2 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dietland Wahner-Roedler, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19422296

Citation

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.

Results Reference

result

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Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels

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