Effect of Choline Supplemented as Phosphatidylcholine on Post-Methionine Loading and Fasting Concentrations of Plasma Homocysteine in Healthy Volunteers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Wageningen Centre for Food Sciences
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Concentrations of plasma homocysteine in the fasting state
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
The purpose of this study is to determine whether supplementation with phosphatidylcholine lowers plasma homocysteine concentrations in healthy men.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Concentrations of plasma homocysteine in the fasting state
Concentrations of plasma homocysteine after a methionine load
Secondary Outcomes
- Lipid concentrations
- Liver enzymes
- Creatinine
- B-vitamins