Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers

Healthy Clinical Trial

Official title:

Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102232
• Other study ID #: TNO4963
• Status: Completed
• Phase: N/A
• First received: January 25, 2005
• Last updated: June 23, 2005
• Start date: May 2003
• Est. completion date: July 2003

Study information

• Verified date: January 2005
• Source: Wageningen Centre for Food Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 71 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Healthy

Intervention

Procedure:
• supplementation with phosphatidylcholine

Locations

Country	Name	City	State
Netherlands	Wageningen Centre for Food Sciences	Wageningen
Netherlands	TNO Nutrition and Food Research	Zeist

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen Centre for Food Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of plasma homocysteine in the fasting state
Primary	Concentrations of plasma homocysteine after a methionine load
Secondary	Lipid concentrations
Secondary	Liver enzymes
Secondary	Creatinine
Secondary	B-vitamins