HealthyNCT00126347
Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
A study testing supplementation with betaine, serine, and folic acid 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 reducing the increase in plasma homocysteine concentrations following an oral methionine load affects 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 betaine, serine, and folic acid
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2002to Jul 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, 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
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 know to interfere with the study
- Fasting plasma total homocysteine > 26 micromol/L
- Alcohol consumption: women >21 consumptions/week; men >28 consumptions/week
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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers
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, 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. 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.
- Conditions
- Healthy, Cardiovascular Diseases
- Being tested
- supplementation with betaine, serine, and folic acid
- Keywords
- betaine, serine, folic acid, methionine load, homocysteine, cardiovascular health, vascular function, human
- 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 betaine, serine, and folic acidProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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 posted3 Aug 2005 (estimated)
- Study startAug 2002
- Study completionJul 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
- NCT00126347
- Sponsor's protocol ID
- P02.0470L
- Status last verified
- Aug 2005
- First submitted
- 2 Aug 2005
- Last updated
- 18 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00126347
- Acronym / sponsor ID
- P02.0470L
- Conditions
- Healthy, Cardiovascular Diseases
- Keywords
- betaine, serine, folic acid, methionine load, homocysteine, cardiovascular health, vascular function, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Wageningen Centre for Food SciencesUniversity, hospital or other
- Study start
- Aug 2002
- Study completion
- Jul 2003
- First posted
- 3 Aug 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 reducing the increase in plasma homocysteine concentrations following an oral methionine load affects 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. 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 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, 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
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 know 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 betaine, serine, and folic acid | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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 18 Aug 2005.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 betaine, serine, and folic acid 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 18 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 before and following an oral methionine load. 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 18 Aug 2005.