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Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102232
Recruitment Status : Completed
First Posted : January 26, 2005
Last Update Posted : June 24, 2005
Information provided by:
Wageningen Centre for Food Sciences

Brief Summary:
The purpose of this study is to determine whether supplementation with phosphatidylcholine lowers plasma homocysteine concentrations in healthy men.

Condition or disease Intervention/treatment Phase
Healthy Cardiovascular Diseases Procedure: supplementation with phosphatidylcholine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers
Study Start Date : May 2003
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Lecithin

Primary Outcome Measures :
  1. Concentrations of plasma homocysteine in the fasting state
  2. Concentrations of plasma homocysteine after a methionine load

Secondary Outcome Measures :
  1. Lipid concentrations
  2. Liver enzymes
  3. Creatinine
  4. B-vitamins

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00102232

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Wageningen Centre for Food Sciences
Wageningen, Netherlands, 6703 HD
TNO Nutrition and Food Research
Zeist, Netherlands, 3700 AJ
Sponsors and Collaborators
Wageningen Centre for Food Sciences
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Study Chair: Petra Verhoef, PhD Wageningen Centre for Food Sciences
Principal Investigator: Elizabeth J Brink, PhD TNO Nutrition and Food Research

Additional Information:
Layout table for additonal information Identifier: NCT00102232    
Other Study ID Numbers: TNO4963
First Posted: January 26, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2005
Keywords provided by Wageningen Centre for Food Sciences:
cardiovascular disease prevention
cardiovascular health
Additional relevant MeSH terms:
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Cardiovascular Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents