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Sponsored by: |
Wageningen Centre for Food Sciences |
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Information provided by: | Wageningen Centre for Food Sciences |
ClinicalTrials.gov Identifier: | NCT00126347 |
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.
Condition | Intervention |
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Healthy Cardiovascular Diseases |
Procedure: supplementation with betaine, serine, and folic acid |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers |
Estimated Enrollment: | 40 |
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.
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 |
Study Chair: | Petra Verhoef, PhD | Wageningen Centre for Food Sciences |
Study ID Numbers: | P02.0470L |
Study First Received: | August 2, 2005 |
Last Updated: | August 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00126347 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
betaine serine folic acid methionine load |
homocysteine cardiovascular health vascular function human |
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 |