- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126347
Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wageningen, Netherlands
- Wageningen Centre for Food Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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concentrations of plasma homocysteine before and following an oral methionine load
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vascular function, measured as flow mediated vasodilation before and following an oral methionine load
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Secondary Outcome Measures
Outcome Measure |
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blood pressure
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B-vitamins
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P02.0470L
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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