HealthyNCT00102232
Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers
A study testing supplementation with phosphatidylcholine in people with Healthy and Cardiovascular Diseases, run by Wageningen Centre for Food Sciences at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether supplementation with phosphatidylcholine lowers plasma homocysteine concentrations in healthy men. Read more about this study
- Who is it for?
- Ages 50 to 71 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cardiovascular Diseases
- What is being tested?
- supplementation with phosphatidylcholine
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 2 sitesNetherlands
- Study dates
- May 2003to 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 71 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests
- Body Mass Index (BMI) ≤ 33 kg/m2
- Normal Dutch eating habits, including use of breakfast
- Willing not to use supplements containing B-vitamins, lecithin, choline (derivatives) or betaine from the oral information session until the end of the study
- Voluntary participation
- Having given their written informed consent
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- Willing to comply with the study procedures, including dietary restrictions
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension
- Use of medication known to interfere with homocysteine metabolism
- Plasma total homocysteine concentrations > 26 µmol/L
- Plasma vitamin B6 concentrations ≤ 15 nmol/L
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- Serum vitamin B12 concentrations < 138 pmol/L
- Serum folic acid concentrations < 5.0 nmol/L
- Alcohol consumption > 28 units/week
- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported food allergy
- Reported vegan or macrobiotic
- Use of B-vitamin supplements, lecithin, or supplements containing choline (derivatives) or betaine, more than once weekly < 1 month before screening
- Recent blood or plasma donation (< 1 month prior to the start of the study)
- Not willing to stop blood or plasma donation during the study
- Personnel of TNO Nutrition and Food Research, their partner and their relatives in the first and second remove
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Wageningen Centre for Food Sciences
Wageningen, 6703 HD
TNO Nutrition and Food Research
Zeist, 3700 AJ
About this study
Official title: Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers
The purpose of this study is to determine whether supplementation with phosphatidylcholine lowers plasma homocysteine concentrations in healthy men.
Read the detailed description
A high homocysteine concentration is a potential risk for cardiovascular disease. Plasma homocysteine concentrations can be lowered through betaine supplementation. However, effects of choline supplementation, the precursor for betaine, on plasma homocysteine concentrations in healthy humans are unknown. If supplementation with choline or phosphatidylcholine, the form in which choline occurs in foods, lowers homocysteine concentrations, then extra intake of these compounds may lower cardiovascular disease risk in humans.
Comparison: We compared the effects of supplementation with phosphatidylcholine to the effects of a placebo on fasting and post-methionine concentrations of plasma homocysteine in healthy men.
- Conditions
- Healthy, Cardiovascular Diseases
- Being tested
- supplementation with phosphatidylcholine
- Keywords
- phosphatidylcholine, choline, 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 phosphatidylcholineProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of plasma homocysteine in the fasting state
Concentrations of plasma homocysteine after a methionine load
Secondary outcomes (4)
Lipid concentrations
Liver enzymes
Creatinine
B-vitamins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2005 (estimated)
- Study startMay 2003
- 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
- 26 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 SciencesElizabeth J Brink, PhD, Principal investigator, TNO Nutrition and Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102232
- Sponsor's protocol ID
- TNO4963
- Status last verified
- Jan 2005
- First submitted
- 25 Jan 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00102232
- Acronym / sponsor ID
- TNO4963
- Conditions
- Healthy, Cardiovascular Diseases
- Keywords
- phosphatidylcholine, choline, homocysteine, cardiovascular disease prevention, human, cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- Wageningen Centre for Food SciencesUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Jul 2003
- First posted
- 26 Jan 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 supplementation with phosphatidylcholine lowers plasma homocysteine concentrations in healthy men.
Detailed description
A high homocysteine concentration is a potential risk for cardiovascular disease. Plasma homocysteine concentrations can be lowered through betaine supplementation. However, effects of choline supplementation, the precursor for betaine, on plasma homocysteine concentrations in healthy humans are unknown. If supplementation with choline or phosphatidylcholine, the form in which choline occurs in foods, lowers homocysteine concentrations, then extra intake of these compounds may lower cardiovascular disease risk in humans.
Comparison: We compared the effects of supplementation with phosphatidylcholine to the effects of a placebo on fasting and post-methionine concentrations of plasma homocysteine in healthy men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 71 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy males as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests
- Body Mass Index (BMI) ≤ 33 kg/m2
- Normal Dutch eating habits, including use of breakfast
- Willing not to use supplements containing B-vitamins, lecithin, choline (derivatives) or betaine from the oral information session until the end of the study
- Voluntary participation
Key exclusion criteria (19 listed)
- Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension
- Use of medication known to interfere with homocysteine metabolism
- Plasma total homocysteine concentrations > 26 µmol/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 phosphatidylcholine | Procedure or surgery | – |
Primary outcome
Concentrations of plasma homocysteine in the fasting state
Concentrations of plasma homocysteine after a methionine load
4 secondary outcomes
Lipid concentrations
Liver enzymes
Creatinine
B-vitamins
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 24 Jun 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
Elizabeth J Brink, PhD principal investigator
TNO Nutrition and Food Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation with phosphatidylcholine in people with Healthy and Cardiovascular Diseases, run by Wageningen Centre for Food Sciences at 2 sites 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 9 inclusion and 19 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 the 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 24 Jun 2005.