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Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075032
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Hospital General Universitario Reina Sofía de Murcia
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Pomegranate extract Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled and crossover trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
Actual Study Start Date : June 10, 2018
Actual Primary Completion Date : July 21, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pomegranate extract-1
Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks
Dietary Supplement: Pomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks

Placebo Comparator: Placebo-1
Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks
Other: Placebo
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks

Placebo Comparator: Placebo-2
Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out
Other: Placebo
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks

Experimental: Pomegranate extract-2
Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out.
Dietary Supplement: Pomegranate extract
Pomegranate extract consumption (900 mg/day) for 4 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075032


Locations
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Spain
Spanish National Research Council (CSIC)
Murcia, Spain, 30100
Sponsors and Collaborators
National Research Council, Spain
Hospital General Universitario Reina Sofía de Murcia
Investigators
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Principal Investigator: Juan C Espín, PhD Spanish National Research Council (CSIC)
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Responsible Party: National Research Council, Spain
ClinicalTrials.gov Identifier: NCT04075032    
Other Study ID Numbers: AGL2015-64124-R(2)
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Research Council, Spain:
metabolic syndrome
pomegranate
gut microbiota
polyphenol
polymedication
inflammation
obesity
diabetes
hypertension
hyperlipidemia
urolithins
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases