Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00126347
• Date of registration: 02/08/2005
• Prospective Registration: No
• 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
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Petra Verhoef, PhD
• Affiliation: Wageningen Centre for Food Sciences

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)

blood pressure

B-vitamins

Secondary ID(s)

P02.0470L

Source(s) of Monetary Support

Please refer to primary and secondary sponsors