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Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

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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

Tracking Information
First Submitted Date  ICMJE August 22, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE June 10, 2018
Actual Primary Completion Date July 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
Increase (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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2019)
  • Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP) [ Time Frame: Changes from baseline at 30 days vs placebo ]
    Evaluation of metabolic endotoxemia
  • 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.
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Decrease (10%) of circulating levels of lipopolysaccharide binding protein (LBP) [ Time Frame: Changes from baseline at 30 days vs placebo ]
    Evaluation of metabolic endotoxemia
  • Improvement (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.
  • Improvement (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
  • Improvement (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
  • Decrease (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
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
Official Title  ICMJE Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Pomegranate extract-1
    Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks
    Intervention: Dietary Supplement: Pomegranate extract
  • Placebo Comparator: Placebo-1
    Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks
    Intervention: Other: Placebo
  • 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
    Intervention: Other: Placebo
  • 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.
    Intervention: Dietary Supplement: Pomegranate extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date July 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075032
Other Study ID Numbers  ICMJE AGL2015-64124-R(2)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Research Council, Spain
Study Sponsor  ICMJE National Research Council, Spain
Collaborators  ICMJE Hospital General Universitario Reina Sofía de Murcia
Investigators  ICMJE
Principal Investigator: Juan C Espín, PhD Spanish National Research Council (CSIC)
PRS Account National Research Council, Spain
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP