Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

National Research Council, Spain60 enrolled

Overview

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, and iii) the modulation of the gut microbiota.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Pomegranate extractDIETARY_SUPPLEMENT

Pomegranate extract consumption (900 mg/day) for 4 weeks

PlaceboOTHER

Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Spanish National Research Council (CSIC)

Murcia, Spain

Outcomes

Primary Outcomes

Change (1 log units) of Bacteroidetes per gram of feces

Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)

Time frame: Change from baseline at 30 days vs placebo