Status:
COMPLETED
Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
Lead Sponsor:
Wageningen Centre for Food Sciences
Conditions:
Healthy
Cardiovascular Diseases
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
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, irrespe...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00126347
Start Date
August 1 2002
End Date
July 1 2003
Last Update
August 18 2005
Active Locations (1)
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1
Wageningen Centre for Food Sciences
Wageningen, Netherlands