Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans
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.
Procedure: supplementation with folic acid and betaine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers|
- Concentrations of plasma homocysteine in fasting state
- Vascular function, measured as flow mediated vasodilation, in fasting state
- Lipid concentrations
- Blood pressure
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||June 2003|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102843
|Wageningen Centre for Food Sciences|
|Wageningen, Netherlands, 6703 HD|
|Study Chair:||Petra Verhoef, PhD||Wageningen Centre for Food Sciences|