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Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pomegranate extract
Placebo
Sponsored by
National Research Council, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, pomegranate, gut microbiota, polyphenol, polymedication, inflammation, obesity, diabetes, hypertension, hyperlipidemia, urolithins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Spanish National Research Council (CSIC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

Pomegranate extract-1

Placebo-1

Placebo-2

Pomegranate extract-2

Arm Description

Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks

Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks

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

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.

Outcomes

Primary Outcome Measures

Change (1 log units) of Bacteroidetes per gram of feces
Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)

Secondary Outcome Measures

Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)
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).
Determination of metabolic and inflammatory markers in serum samples.
Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).
Determination of fibrinolytic, inflammatory and metabolic markers in serum samples
Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)
Measurement of cell adhesion molecules in serum samples
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
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)

Full Information

First Posted
August 22, 2019
Last Updated
September 8, 2020
Sponsor
National Research Council, Spain
Collaborators
Hospital General Universitario Reina Sofía de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04075032
Brief Title
Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
Official Title
Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
July 21, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Council, Spain
Collaborators
Hospital General Universitario Reina Sofía de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, pomegranate, gut microbiota, polyphenol, polymedication, inflammation, obesity, diabetes, hypertension, hyperlipidemia, urolithins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, placebo-controlled and crossover trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomegranate extract-1
Arm Type
Experimental
Arm Description
Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks
Arm Title
Placebo-1
Arm Type
Placebo Comparator
Arm Description
Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks
Arm Title
Placebo-2
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Pomegranate extract-2
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Pomegranate extract
Intervention Description
Pomegranate extract consumption (900 mg/day) for 4 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
Primary Outcome Measure Information:
Title
Change (1 log units) of Bacteroidetes per gram of feces
Description
Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)
Time Frame
Change from baseline at 30 days vs placebo
Secondary Outcome Measure Information:
Title
Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)
Description
Evaluation of metabolic endotoxemia
Time Frame
Changes from baseline at 30 days vs placebo
Title
Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).
Description
Determination of metabolic and inflammatory markers in serum samples.
Time Frame
Changes from baseline at 30 days vs placebo
Title
Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).
Description
Determination of fibrinolytic, inflammatory and metabolic markers in serum samples
Time Frame
Changes from baseline at 30 days vs placebo
Title
Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)
Description
Measurement of cell adhesion molecules in serum samples
Time Frame
Changes from baseline at 30 days vs placebo
Title
Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)
Description
Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples
Time Frame
Changes from baseline at 30 days vs placebo
Title
Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases
Description
SNP genotyping of patients (DNA extracted from whole blood)
Time Frame
Baseline values at inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Espín, PhD
Organizational Affiliation
Spanish National Research Council (CSIC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spanish National Research Council (CSIC)
City
Murcia
ZIP/Postal Code
30100
Country
Spain

12. IPD Sharing Statement

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Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

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