HealthyNCT00102843
Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans
A study testing supplementation with folic acid and betaine in people with Healthy and Cardiovascular Diseases, run by Wageningen Centre for Food Sciences at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cardiovascular Diseases
- What is being tested?
- supplementation with folic acid and betaine
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2002to Jun 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers
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.
Read the 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. We investigated whether lowering of fasting homocysteine concentrations via supplementation with 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: We compare the effects of supplementation with folic acid to the effects of betaine, and to the effects of a placebo on plasma homocysteine concentrations and vascular function in healthy humans.
- Conditions
- Healthy, Cardiovascular Diseases
- Being tested
- supplementation with folic acid and betaine
- Keywords
- folic acid, betaine, homocysteine, cardiovascular disease prevention, human, Cardiovascular health
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation with folic acid and betaineProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of plasma homocysteine in fasting state
Vascular function, measured as flow mediated vasodilation, in fasting state
Secondary outcomes (3)
Lipid concentrations
B-vitamins
Blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2005 (estimated)
- Study startOct 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Wageningen Centre for Food Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Petra Verhoef, PhD, Study chair, Wageningen Centre for Food Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102843
- Sponsor's protocol ID
- P02.0505L
- Status last verified
- Aug 2005
- First submitted
- 3 Feb 2005
- Last updated
- 3 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00102843
- Acronym / sponsor ID
- P02.0505L
- Conditions
- Healthy, Cardiovascular Diseases
- Keywords
- folic acid, betaine, homocysteine, cardiovascular disease prevention, human, Cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Wageningen Centre for Food SciencesUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Jun 2003
- First posted
- 4 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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. We investigated whether lowering of fasting homocysteine concentrations via supplementation with 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: We compare the effects of supplementation with folic acid to the effects of betaine, and to the effects of a placebo on plasma homocysteine concentrations and vascular function in healthy humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supplementation with folic acid and betaine | Procedure or surgery | – |
Primary outcome
Concentrations of plasma homocysteine in fasting state
Vascular function, measured as flow mediated vasodilation, in fasting state
3 secondary outcomes
Lipid concentrations
B-vitamins
Blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Verhoef, PhD study chair
Wageningen Centre for Food Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation with folic acid and betaine in people with Healthy and Cardiovascular Diseases, run by Wageningen Centre for Food Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of plasma homocysteine in fasting state. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2005.