Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

Not Applicable

Completed

• Conditions: Metabolic Syndrome

• 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

Study Timeline

• Study Start: 2018-06-10
• Primary Completion: 2019-07-21
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

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

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