Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126347
Status:
COMPLETED
Last Update Posted:
2005-08-18
First Post:
2005-08-02
Brief Title:
Effect of Betaine Serine and Folic Acid on Vascular Function in Healthy Volunteers
Sponsor:
Wageningen Centre for Food Sciences
Organization:
Wageningen Centre for Food Sciences
Study Overview
Official Title:
Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load 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 reducing the increase in plasma homocysteine concentrations following an oral methionine load affects 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 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
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
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