Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

Metabolic Syndrome Clinical Trial

Official title:

Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075032
• Other study ID #: AGL2015-64124-R(2)
• Status: Completed
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: July 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Pomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks

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

Locations

Country	Name	City	State
Spain	Spanish National Research Council (CSIC)	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Hospital General Universitario Reina Sofía de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (1 log units) of Bacteroidetes per gram of feces	Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)	Change from baseline at 30 days vs placebo
Secondary	Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)	Evaluation of metabolic endotoxemia	Changes from baseline at 30 days vs placebo
Secondary	Change (10%) of ghrelin, TNF-a, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).	Determination of metabolic and inflammatory markers in serum samples.	Changes from baseline at 30 days vs placebo
Secondary	Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).	Determination of fibrinolytic, inflammatory and metabolic markers in serum samples	Changes from baseline at 30 days vs placebo
Secondary	Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)	Measurement of cell adhesion molecules in serum samples	Changes from baseline at 30 days vs placebo
Secondary	Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)	Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples	Changes from baseline at 30 days vs placebo
Secondary	Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases	SNP genotyping of patients (DNA extracted from whole blood)	Baseline values at inclusion