Healthy Clinical Trial
Official title:
Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers
The purpose of this study is to determine whether lowering of fasting homocysteine concentrations improves vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.
A high plasma homocysteine is a potential risk factor for cardiovascular disease and death.
However, it remains uncertain whether homocysteine per se, low status of folate, or other
factors related to methionine metabolism are involved in the pathogenesis of cardiovascular
disease. Previous studies have shown that a high concentration of homocysteine in blood is
related to an impaired vascular function in the arteries, an indicator of cardiovascular
disease risk. Virtually all intervention trials used folic acid as a homocysteine-lowering
agent, which may however affect vascular function through mechanisms not related to
homocysteine. We investigated whether lowering of fasting homocysteine concentrations via
supplementation with betaine or folic acid improves vascular function in healthy volunteers,
in order to distinguish between effects of folic acid and of homocysteine-lowering per se.
Comparison: We compare the effects of supplementation with folic acid to the effects of
betaine, and to the effects of a placebo on plasma homocysteine concentrations and vascular
function in healthy humans.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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