Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, pomegranate, gut microbiota, polyphenol, polymedication, inflammation, obesity, diabetes, hypertension, hyperlipidemia, urolithins
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.
Interventions
DIETARY_SUPPLEMENTPomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks
OTHERPlacebo
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
Sponsors
Hospital General Universitario Reina Sofía de Murcia
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled and crossover trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 circulating levels of lipopolysaccharide binding protein (LBP) | Changes from baseline at 30 days vs placebo | Evaluation of metabolic endotoxemia |
| 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) |
| 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 |
Countries
Spain
Outcome results
None listed