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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT00852735
Eligibility Criteria:
Inclusion Criteria:
* Male
* Age : 30 to 65
* Body mass index between 25 and 30 kg/m²
* Weight lower than 110 kg
* Subject considered as normal after clinical examination and medical questionnaire
* Subject giving his written informed consent
* Subject willing to comply with the study procedures
* Affiliated to National Health Insurance
Exclusion Criteria:
* Biological results judged abnormal by investigator
* Positive serologies to HIV or HCV
* Previous medical and/or surgery judged by the investigator as incompatible with the study
* Taking medicine: hypocholesterolemic,beta blockers, IEC,
* Diabetes1 and 2
* High blood pressure
* Digestive, cardiovascular, renal, liver, tumor or thyroid diseases in the last 5 years
* Infectious or inflammatory diseases in the last 5 years
* Previous heavy intestine surgery (except appendectomy)
* Triglycerides\> 4 g/L
* Dyslipidemia: HDL cholesterol\< 0.4 g/L or LDL/HDL\>6.25
* blood donation done less than 2 month before the start of the study
* Particular diet: vegetarian, vegan...
* Anormal dietary habits
* Consumption of food complements: antioxidant, ...
* intense physical exercise practise (\>5 h per week)
* Tobacco, alcohol:more than 30 g of alcohol/day, i.e.3 glasses/day, smoking \> 5 cigarettes /day
* No affiliated to National Health Insurance people
* Refusal to sign informed consent
* Refusal to be registered on the National Volunteers Data file
* Currently participating or who having got 4500 E in this year before to have participated in another clinical trial
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT00852735
Study Brief:
Protocol Section:
NCT00852735