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 @ 3:39 PM
Ignite Modification Date:
2025-12-24 @ 3:39 PM
NCT ID:
NCT03669692
Eligibility Criteria:
Inclusion Criteria:
* Signature of specific informed consent for this study.
* Metabolic syndrome according to WHO criteria
* Current intake food pattern \> 14 hours of duration.
* Total PSA below 2,5 ng/mL or total PSA 4 - 10 ng/mL and free/total PSA \> 25%
* IPSS score \> 9 points
* Maximal flow rate \< 15 cc/secs
* Prostatic volume \> 40 cc.
Exclusion Criteria:
* Active oncological disease; includes patients already treated without complete remission or in current active treatment.
* PSA 4 - 10 ng/mL and free/total PSA \< 25% or PSA \> 10 ng/mL
* Previous prostatic biopsy in the last 5 years.
* Treatment with prostatic phytotherapy in the last 4 weeks.
* BPH alphablocking treatment in the last 6 weeks.
* 5-alpha-reductase treatment in the last 6 months.
* Anticholinergic or betamimetics treatment in the last 4 weeks
* Eating, weight management disorder or previous bariatric surgery.
* Concurrent treatment with the following drugs in the fasting period: AAS and NSAIDs (except paracetamol).
* Concurrent treatment with any of the following steroids: prednisolone, budesonide, dexamethasone, fluidcortisone, hydrocortisone or prednisone.
* Major mental illness, which does not allow informed consent.
* Previous cardiovascular event in the last 12 months.
* Liver, gastrointestinal, renal or severe previous endocrine or decompensated disease in the last 12 months.
* Presence of significant vesical lithiasis.
* Type I diabetic patients
* Type II diabetic patients in treatment with sulfonylureas and sodium-glucose cotransport inhibitors, as well as in patients with insulin therapy.
* Loss of patient follow-up
* Non-compliance with protocol procedures.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT03669692
Study Brief:
Protocol Section:
NCT03669692