Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Wageningen Centre for Food Sciences |
---|---|
Information provided by: | Wageningen Centre for Food Sciences |
ClinicalTrials.gov Identifier: | NCT00102843 |
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.
Condition | Intervention |
---|---|
Healthy Cardiovascular Diseases |
Procedure: supplementation with folic acid and betaine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 50 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Wageningen Centre for Food Sciences | |
Wageningen, Netherlands, 6703 HD |
Study Chair: | Petra Verhoef, PhD | Wageningen Centre for Food Sciences |
Study ID Numbers: | P02.0505L |
Study First Received: | February 3, 2005 |
Last Updated: | August 2, 2005 |
ClinicalTrials.gov Identifier: | NCT00102843 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
folic acid betaine homocysteine |
cardiovascular disease prevention human Cardiovascular health |
Folic Acid Healthy Betaine |
Antimetabolites Lipotropic Agents Vitamin B Complex Molecular Mechanisms of Pharmacological Action Hematinics Antilipemic Agents Growth Substances Hematologic Agents |
Physiological Effects of Drugs Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients |