Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers - Full Text View

Sponsored by:	Wageningen Centre for Food Sciences
Information provided by:	Wageningen Centre for Food Sciences
ClinicalTrials.gov Identifier:	NCT00102232

Purpose

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

Condition	Intervention
Healthy Cardiovascular Diseases	Procedure: supplementation with phosphatidylcholine

Drug Information available for: Homocysteine Methionine Lecithin Choline Choline bitartrate Choline chloride Choline dihydrogen citrate Choline salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers

Further study details as provided by Wageningen Centre for Food Sciences:

Primary Outcome Measures:

Concentrations of plasma homocysteine in the fasting state
Concentrations of plasma homocysteine after a methionine load

Secondary Outcome Measures:

Lipid concentrations
Liver enzymes
Creatinine
B-vitamins

Estimated Enrollment:	26
Study Start Date:	May 2003
Estimated Study Completion Date:	July 2003

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.

Eligibility

Ages Eligible for Study:	50 Years to 71 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102232

Locations

Netherlands
TNO Nutrition and Food Research
Zeist, Netherlands, 3700 AJ
Wageningen Centre for Food Sciences
Wageningen, Netherlands, 6703 HD

Sponsors and Collaborators

Wageningen Centre for Food Sciences

Investigators

Study Chair:	Petra Verhoef, PhD	Wageningen Centre for Food Sciences
Principal Investigator:	Elizabeth J Brink, PhD	TNO Nutrition and Food Research

More Information

Wageningen Centre for Food Sciences This link exits the ClinicalTrials.gov site

Study ID Numbers:	TNO4963
Study First Received:	January 25, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00102232
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen Centre for Food Sciences:

phosphatidylcholine
choline
homocysteine

cardiovascular disease prevention
human
cardiovascular health

Study placed in the following topic categories:

Choline
Healthy

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009