OBJECTIVES: To determine if exogenous S-adenosyl-l-methionine (AdoMet), a commonly used nutritional supplement, increases the level of plasma homocysteine (Hcy), a potential cardiovascular risk factor, in healthy human subjects. DESIGN: Double-blind, placebo-controlled, randomized clinical trial. SETTING: Mayo Clinic, Rochester, Minnesota. SUBJECTS:Fifty-two (52) healthy human volunteers. INTERVENTION: Subjects received placebo or AdoMet (800 mg per day) for 4 weeks. Hcy levels were measured before and after administration of AdoMet or placebo. OUTCOME MEASURES: The primary outcome measure was change in Hcy level. Secondary outcome measures included an interim Hcy determination (at 2 weeks) and changes in levels of high-sensitivity C-reactive protein (hsCRP), lipids, and alanine aminotransferase. RESULTS: There was no statistically significant change in Hcy between groups. Similarly, no statistically significant differences in change in Hcy or hsCRP levels were observed at 2 or 4 weeks. There was a small but statistically significant increase (p < 0.04) in alanine aminotransferase at week 2 and a statistically significant decrease (p < 0.04) in total cholesterol in the AdoMet group compared with the placebo group. CONCLUSIONS: AdoMet at a daily dose of 800 mg for 4 weeks does not appear to significantly affect Hcy levels in the blood.
RCT Entities:
OBJECTIVES: To determine if exogenous S-adenosyl-l-methionine (AdoMet), a commonly used nutritional supplement, increases the level of plasma homocysteine (Hcy), a potential cardiovascular risk factor, in healthy human subjects. DESIGN: Double-blind, placebo-controlled, randomized clinical trial. SETTING:Mayo Clinic, Rochester, Minnesota. SUBJECTS: Fifty-two (52) healthy human volunteers. INTERVENTION: Subjects received placebo or AdoMet (800 mg per day) for 4 weeks. Hcy levels were measured before and after administration of AdoMet or placebo. OUTCOME MEASURES: The primary outcome measure was change in Hcy level. Secondary outcome measures included an interim Hcy determination (at 2 weeks) and changes in levels of high-sensitivity C-reactive protein (hsCRP), lipids, and alanine aminotransferase. RESULTS: There was no statistically significant change in Hcy between groups. Similarly, no statistically significant differences in change in Hcy or hsCRP levels were observed at 2 or 4 weeks. There was a small but statistically significant increase (p < 0.04) in alanine aminotransferase at week 2 and a statistically significant decrease (p < 0.04) in total cholesterol in the AdoMet group compared with the placebo group. CONCLUSIONS:AdoMet at a daily dose of 800 mg for 4 weeks does not appear to significantly affect Hcy levels in the blood.
Authors: Guido Schnyder; Marco Roffi; Yvonne Flammer; Riccardo Pin; Franz R Eberli; Bernhard Meier; Zoltan G Turi; Otto M Hess Journal: Am J Cardiol Date: 2003-05-15 Impact factor: 2.778
Authors: M J Stampfer; M R Malinow; W C Willett; L M Newcomer; B Upson; D Ullmann; P V Tishler; C H Hennekens Journal: JAMA Date: 1992-08-19 Impact factor: 56.272
Authors: J F Lipinski; B M Cohen; F Frankenburg; M Tohen; C Waternaux; R Altesman; B Jones; P Harris Journal: Am J Psychiatry Date: 1984-03 Impact factor: 18.112