Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
Not Applicable
Completed
- Conditions
- Metabolic Syndrome
- Interventions
- Dietary Supplement: Pomegranate extractOther: Placebo
- Registration Number
- NCT04075032
- Lead Sponsor
- National Research Council, Spain
- 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, and iii) the modulation of the gut microbiota.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pomegranate extract-2 Pomegranate extract 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-1 Pomegranate extract Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks Placebo-1 Placebo Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks Placebo-2 Placebo 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
- Primary Outcome Measures
Name Time Method Change (1 log units) of Bacteroidetes per gram of feces Change from baseline at 30 days vs placebo Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)
- Secondary Outcome Measures
Name Time Method Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL). Changes from baseline at 30 days vs placebo Determination of metabolic and inflammatory markers in serum samples.
Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP) Changes from baseline at 30 days vs placebo Evaluation of metabolic endotoxemia
Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL). Changes from baseline at 30 days vs placebo Determination of fibrinolytic, inflammatory and metabolic markers in serum samples
Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL) Changes from baseline at 30 days vs placebo Measurement of cell adhesion molecules in serum samples
Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL) Changes from baseline at 30 days vs placebo Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples
Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases Baseline values at inclusion SNP genotyping of patients (DNA extracted from whole blood)
Trial Locations
- Locations (1)
Spanish National Research Council (CSIC)
🇪🇸Murcia, Spain