Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers - Full Text View

Sponsored by:	Wageningen Centre for Food Sciences
Information provided by:	Wageningen Centre for Food Sciences
ClinicalTrials.gov Identifier:	NCT00126347

Purpose

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
Healthy Cardiovascular Diseases	Procedure: supplementation with betaine, serine, and folic acid

Drug Information available for: Folic acid Homocysteine Methionine Serine Betaine Betaine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Wageningen Centre for Food Sciences:

Primary Outcome Measures:

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

Secondary Outcome Measures:

B-vitamins
blood pressure

Estimated Enrollment:	40
Study Start Date:	August 2002
Estimated Study Completion Date:	July 2003

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.

Eligibility

Ages Eligible for Study:	50 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Apparently healthy
Women postmenopausal: two or more years after last menstruation. If the uterus was surgically removed, the women must be 55 years or older
Normal blood values for: hematology, total homocysteine, lipids, vitamin B6, vitamin B12, folic acid, liver enzymes, creatinine
Absence of protein and glucose in urine sample
Body mass index (BMI) between 18 and 30 kg/m2
Good ultrasound visibility of the brachial artery, judged by a sonographer.
Willing not to use supplements containing B-vitamins, antioxidant vitamins (A, beta-carotene, C and E) or n-3 fatty acids/fish oil supplements from screening day (>2 months before start of the study) until end of study
Willing not to be blood or plasmapherese donor from 4 weeks before the screening day, and 4 weeks before the start of the study until the end of study

Exclusion Criteria:

Any chronic or acute disease (e.g. diabetes, renal disease, inflammation)
Current, or history of cardiovascular disease
Hypertension
Medical history or surgical events know to interfere with the study
Fasting plasma total homocysteine > 26 micromol/L
Alcohol consumption: women >21 consumptions/week; men >28 consumptions/week
Weight loss or gain > 2 kg in the month prior to screening
Any special diet (prescribed, slimming, macrobiotic or total vegetarian. Sole exclusion of meat and fish from a otherwise ‘normal’ western diet is allowed).
Lactose intolerance
Use of supplements containing B-vitamins more than once weekly in the period from 3 months before the screening day
Participation in any other trial up to 3 months before this study
Use of medication known to interfere with the study outcome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126347

Locations

Netherlands
Wageningen Centre for Food Sciences
Wageningen, Netherlands

Sponsors and Collaborators

Wageningen Centre for Food Sciences

Investigators

Study Chair:

Petra Verhoef, PhD

Wageningen Centre for Food Sciences

More Information

Wageningen Centre for Food Sciences This link exits the ClinicalTrials.gov site

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)

Keywords provided by Wageningen Centre for Food Sciences:

betaine
serine
folic acid
methionine load

homocysteine
cardiovascular health
vascular function
human

Study placed in the following topic categories:

Folic Acid
Healthy
Betaine

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009