NCT00284011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

January 30, 2006

Last Update Submit

January 4, 2012

Conditions

Heart Disease

Keywords

SAMeAdoMetMethylationHomocysteineDietary SupplementS-Adenosyl-L-Methionine

Outcome Measures

Primary Outcomes (1)

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

    1 Month

Secondary Outcomes (1)

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

    2 Weeks

Study Arms (2)

SAMe

ACTIVE COMPARATOR

Two 400 mg pills.

Dietary Supplement: SAMe

Placebo

PLACEBO COMPARATOR

Two placebo pills (identical in appearance to SAMe).

Other: Placebo

Interventions

SAMeDIETARY_SUPPLEMENT

800 mg dose daily for 4 weeks.

Also known as: AdoMet, S-Adenosyl-L-Methionine
SAMe
PlaceboOTHER

2 placebo pills daily for 4 weeks.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men age 18 - 65
  • Able to understand and sign a consent form

You may not qualify if:

  • Smoking
  • Pregnant or lactating
  • Women actively trying to conceive
  • Diagnosis of panic disorder or bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 19422296RESULT

MeSH Terms

Conditions

Heart Diseases

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethionineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Dietland Wahner-Roedler, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

June 1, 2005

Primary Completion

April 1, 2006

Study Completion

May 1, 2006

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

US(1)