Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
The purpose of this study is to determine whether reducing the increase in plasma homocysteine concentrations following an oral methionine load affects vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.
Procedure: supplementation with betaine, serine, and folic acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers|
- concentrations of plasma homocysteine before and following an oral methionine load
- vascular function, measured as flow mediated vasodilation before and following an oral methionine load
- blood pressure
|Study Start Date:||August 2002|
|Estimated Study Completion Date:||July 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. The researchers investigated whether reduction in homocysteine concentrations following a methionine load, via supplementation with serine, 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: The effects of supplementation with serine, folic acid and betaine (all together with an oral methionine load) were compared to the effects of a placebo (together with a methionine load) on plasma homocysteine concentrations and on vascular function following methionine loading in healthy volunteers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126347
|Wageningen Centre for Food Sciences|
|Study Chair:||Petra Verhoef, PhD||Wageningen Centre for Food Sciences|