NCT00102232

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2003

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2005

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2005

First QC Date

January 25, 2005

Last Update Submit

June 23, 2005

Conditions

HealthyCardiovascular Diseases

Keywords

phosphatidylcholinecholinehomocysteinecardiovascular disease preventionhumancardiovascular health

Outcome Measures

Primary Outcomes (2)

  • Concentrations of plasma homocysteine in the fasting state

  • Concentrations of plasma homocysteine after a methionine load

Secondary Outcomes (4)

  • Lipid concentrations

  • Liver enzymes

  • Creatinine

  • B-vitamins

Interventions

supplementation with phosphatidylcholinePROCEDURE

Eligibility Criteria

Age50 Years - 71 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wageningen Centre for Food Sciences

Wageningen, 6703 HD, Netherlands

Location

TNO Nutrition and Food Research

Zeist, 3700 AJ, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Dietary SupplementsPhosphatidylcholines

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesGlycerophospholipidsPhosphatidic AcidsGlycerophosphatesPhospholipidsMembrane LipidsLipids

Study Officials

  • Petra Verhoef, PhD

    Wageningen Centre for Food Sciences

    STUDY CHAIR

  • Elizabeth J Brink, PhD

    TNO Nutrition and Food Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2005

First Posted

January 26, 2005

Study Start

May 1, 2003

Study Completion

July 1, 2003

Last Updated

June 24, 2005

Record last verified: 2005-01

Locations

NL(2)