Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
NCT ID: NCT04075032
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-06-10
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Pomegranate extract-1
Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks
Pomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks
Placebo-1
Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks
Placebo
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
Placebo-2
Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out
Placebo
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
Pomegranate extract-2
Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out.
Pomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks
Interventions
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Pomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks
Placebo
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Hospital General Universitario Reina Sofía de Murcia
OTHER
National Research Council, Spain
OTHER_GOV
Responsible Party
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Juan Carlos Espín de Gea
Research Professor
Principal Investigators
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Juan C Espín, PhD
Role: PRINCIPAL_INVESTIGATOR
Spanish National Research Council (CSIC)
Locations
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Spanish National Research Council (CSIC)
Murcia, , Spain
Countries
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Other Identifiers
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AGL2015-64124-R(2)
Identifier Type: -
Identifier Source: org_study_id
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