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Completed

NCT Number: NCT04075032

Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertension Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spanish National Research Council (CSIC)

Murcia, 30100, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pomegranate extract

Dietary Supplement

Pomegranate extract consumption (900 mg/day) for 4 weeks

Placebo

Other

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

Primary outcomes

  1. Change (1 log units) of Bacteroidetes per gram of feces

    Time frame: Change from baseline at 30 days vs placebo

    Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)

Secondary outcomes

  1. Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)

    Time frame: Changes from baseline at 30 days vs placebo

    Evaluation of metabolic endotoxemia

  2. Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).

    Time frame: Changes from baseline at 30 days vs placebo

    Determination of metabolic and inflammatory markers in serum samples.

  3. Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).

    Time frame: Changes from baseline at 30 days vs placebo

    Determination of fibrinolytic, inflammatory and metabolic markers in serum samples

  4. Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)

    Time frame: Changes from baseline at 30 days vs placebo

    Measurement of cell adhesion molecules in serum samples

  5. Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)

    Time frame: Changes from baseline at 30 days vs placebo

    Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples

  6. Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases

    Time frame: Baseline values at inclusion

    SNP genotyping of patients (DNA extracted from whole blood)

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Hospital General Universitario Reina Sofía de Murcia

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2019
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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