Status:
COMPLETED
Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
Lead Sponsor:
National Research Council, Spain
Collaborating Sponsors:
Hospital General Universitario Reina Sofía de Murcia
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers,...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04075032
Start Date
June 10 2018
End Date
December 31 2019
Last Update
September 10 2020
Active Locations (1)
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1
Spanish National Research Council (CSIC)
Murcia, Spain, 30100