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 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT04075032
Eligibility Criteria:
Inclusion Criteria:
* Body mass index \>30 kg/m2 or waist circumference \>94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:
* Triglycerides \>150 mg/dL or under treatment against hypertrigliceridemia.
* Fasting glucose ≥100 mg/dL
* Diagnosed type 2 diabetes mellitus
* HDL-cholesterol (mg/dl) \<40/50 (males/females) or under treatment against low HDLc values.
* Systolic blood pressure \>130 mmHg o diastolic blood pressure \>85 mmHg, or under anti-hypertensive drug treatment.
Exclusion Criteria:
* Age under 18 years
* Pregnancy or breastfeeding
* Antibiotic treatment within one month before inclusion in the trial
* Pomegranate allergy or intolerance (known or suspected)
* Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
* Malignancies
* Consumption of botanicals or dietary supplements within one month before the inclusion and during the trial.
* Consumption of ellagitannin-rich sources within one week before the inclusion and during the trial (pomegranate, walnuts, strawberries, raspberries, tea, blackberries and oak-aged wine).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04075032
Study Brief:
Protocol Section:
NCT04075032