Status:
COMPLETED
Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans
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 lowering of fasting homocysteine concentrations improves vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.
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, blood lipids, vitamin B6, vitamin B12, folate, 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 the 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 plasmapheresis 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 known to interfere with the study.
- Fasting plasma total homocysteine \> 26 micromol/L.
- Alcohol consumption: more than 21 consumptions /week for women, and more than 28 consumptions/week for men.
- 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 an 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 :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00102843
Start Date
October 1 2002
End Date
June 1 2003
Last Update
August 3 2005
Active Locations (1)
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1
Wageningen Centre for Food Sciences
Wageningen, Netherlands, 6703 HD