Viewing Study NCT00102843



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Study NCT ID: NCT00102843
Status: COMPLETED
Last Update Posted: 2005-08-03
First Post: 2005-02-03

Brief Title: Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans
Sponsor: Wageningen Centre for Food Sciences
Organization: Wageningen Centre for Food Sciences

Study Overview

Official Title: Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers
Status: COMPLETED
Status Verified Date: 2005-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None