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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT01691404
Eligibility Criteria:
Inclusion Criteria:
* Systolic Blood Pressure between 125 and 160 mmHg
* Age between 30 and 80 years
* BMI \> 20 and ≤ 40
* No reported current or previous metabolic diseases
* No history of cardiovascular diseases
* No history of renal, liver or thyroid diseases
* No history of gastrointestinal diseases
* No diabetes mellitus
* Fasting laboratory parameters within normal range: complete blood count (RBC, WBC, PLT, HB, HT), renal function (serum creatinine, urea), liver function (ALAT, ASAT, ɣ-GT), and serum glucose.
Exclusion Criteria:
* Body mass index \> 40 and ≤20
* Secondary hypertension
* Weight loss or weight gain of 5 kg or more during the last 2 months
* Usage of non-steroidal anti-inflammatory drugs (acetylsalicylic acid, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study
* Usage of cholesterol-lowering medication
* Daily usage of corticosteroids
* Medical treatment that may affect blood pressure and not able (or willing) to stop
* Taking nutritional supplements and unwilling to discontinue
* Lactating, pregnant or intention to become pregnant during study
* Reported dietary habits, medically prescribed diet, slimming diet
* Reported average alcohol consumption \> 2 glasses/d (men) or \>1 glass/d (women)
* Problems with consuming the supplements or following the study guidelines
* Unwilling to undergo home or office blood pressure measurements
* Recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period
* Reported intense sporting activities \> 10 h/w
* Not agreeing to be informed about unexpected and medically relevant personal test-results, or not agreeing that their general practitioner will be informed about these results
* Participation in another biomedical trial less than 2 months before the start of the study or at the same time
* No signed informed consent form
* Clinical disorders that could interfere with the intervention
* Unable to comply with the study procedure (e.g. holidays, urine collection, blood sampling)
* Smokers
* Difficulty imaging brachial artery by ultrasonography
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT01691404
Study Brief:
Protocol Section:
NCT01691404