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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00102232     History of Changes
Other Study ID Numbers: TNO4963
Study First Received: January 25, 2005
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014