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:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT00869193
Eligibility Criteria:
Inclusion Criteria:
* Male and postmenopausal female subjects in the age ≥ 35 and ≤ 75 at start of the study
* BMI ≥ 18.5 and ≤ 30.0 kg/m2
* Apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range
* Informed consent signed
* Willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study
Exclusion Criteria:
* Mean of 6-hour ambulatory SBP \< 120 mmHg, \> 159 mmHg and/or DBP \> 99 mmHg
* 10-year risk mortality risk on CVD \> 10% according to NHG standard M84. For subjects \> 65 years of age and SBP ≥ 140 mmHg the study physician will assess eligibility
* Irregular pulse or pulse \< 50 or \> 100 bpm
* Intense exercise \>10 h/w
* Reported weight loss/gain \> 10% of body weight in the 6 month preceding pre-study examination
* The habit of smoking during the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT00869193
Study Brief:
Protocol Section:
NCT00869193