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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00126347
Date of registration: 02/08/2005
Primary sponsor: Wageningen Centre for Food Sciences
Public title: Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
Scientific title: Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers
Date of first enrolment: August 2002
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00126347
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention  
Countries of recruitment
Contacts
Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Cardiovascular Diseases
Healthy
Intervention(s)
Procedure: supplementation with betaine, serine, and folic acid
Primary Outcome(s)
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(s)
B-vitamins
blood pressure
Secondary ID(s)
P02.0470L
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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