Effect of Phosphatidylcholine on Plasma Homocysteine in Healthy Volunteers

June 23, 2005 updated by: Wageningen Centre for Food Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Creatinine
B-vitamins
Lipid concentrations
Liver enzymes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen Centre for Food Sciences

Investigators

  • Principal Investigator: Elizabeth J Brink, PhD, TNO Nutrition and Food Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

January 25, 2005

First Submitted That Met QC Criteria

January 25, 2005

First Posted (Estimate)

January 26, 2005

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNO4963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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