Clinical trial NCT04075032: Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
Official title: Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
pomegranate
gut microbiota
polyphenol
polymedication
inflammation
obesity
diabetes
hypertension
hyperlipidemia
urolithins
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Hospital General Universitario Reina Sofía de Murcia
First posted: 2019-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled and crossover trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change (1 log units) of Bacteroidetes per gram of feces
timeFrame: Change from baseline at 30 days vs placebo
Secondary outcomes:
measure: Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)
timeFrame: Changes from baseline at 30 days vs placebo
measure: Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).
timeFrame: Changes from baseline at 30 days vs placebo
measure: Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).
timeFrame: Changes from baseline at 30 days vs placebo
measure: Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)
timeFrame: Changes from baseline at 30 days vs placebo
measure: Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)
timeFrame: Changes from baseline at 30 days vs placebo
measure: Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases
timeFrame: Baseline values at inclusion
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Spanish National Research Council (CSIC)
Study officials:
affiliation: Spanish National Research Council (CSIC)
name: Juan C Espín, PhD
role: PRINCIPAL_INVESTIGATOR
References: