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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAMe | Active Comparator | Two 400 mg pills. |
|
| Placebo | Placebo Comparator | Two placebo pills (identical in appearance to SAMe). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAMe | Dietary Supplement | 800 mg dose daily for 4 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Homocysteine levels pre- and post- one month of SAMe administration. | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests. | 2 Weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dietland Wahner-Roedler, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19422296 | Result | 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. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012436 | S-Adenosylmethionine |
| ID | Term |
|---|---|
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Other | 2 placebo pills daily for 4 weeks. |
|
| D000241 |
| Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |