Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers

Wageningen Centre for Food Sciences

Status

Completed

Conditions

Healthy

Cardiovascular Diseases

Treatments

Procedure: supplementation with phosphatidylcholine

Study type

Interventional

Funder types

Other

Identifiers

NCT00102232

TNO4963

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

50 to 71 years old

Volunteers

Accepts Healthy Volunteers

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