Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Wageningen Centre for Food Sciences
ClinicalTrials.gov Identifier:
NCT00102232
First received: January 25, 2005
Last updated: June 23, 2005
Last verified: January 2005

January 25, 2005
June 23, 2005
May 2003
Not Provided
  • Concentrations of plasma homocysteine in the fasting state
  • Concentrations of plasma homocysteine after a methionine load
Same as current
Complete list of historical versions of study NCT00102232 on ClinicalTrials.gov Archive Site
  • Lipid concentrations
  • Liver enzymes
  • Creatinine
  • B-vitamins
Same as current
Not Provided
Not Provided
 
Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Healthy
  • Cardiovascular Diseases
Procedure: supplementation with phosphatidylcholine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
July 2003
Not Provided

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
Male
50 Years to 71 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00102232
TNO4963
Not Provided
Not Provided
Wageningen Centre for Food Sciences
Not Provided
Study Chair: Petra Verhoef, PhD Wageningen Centre for Food Sciences
Principal Investigator: Elizabeth J Brink, PhD TNO Nutrition and Food Research
Wageningen Centre for Food Sciences
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP