Status:
COMPLETED
Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers
Lead Sponsor:
Wageningen Centre for Food Sciences
Conditions:
Healthy
Cardiovascular Diseases
Eligibility:
MALE
50-71 years
Phase:
NA
Brief Summary
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 supplem...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2003
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00102232
Start Date
May 1 2003
End Date
July 1 2003
Last Update
June 24 2005
Active Locations (2)
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1
Wageningen Centre for Food Sciences
Wageningen, Netherlands, 6703 HD
2
TNO Nutrition and Food Research
Zeist, Netherlands, 3700 AJ