Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00102232
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
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
71 Years
Study:
NCT00102232
Study Brief:
Protocol Section:
NCT00102232