NCT04075032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

August 22, 2019

Last Update Submit

September 8, 2020

Conditions

Metabolic Syndrome

Keywords

metabolic syndromepomegranategut microbiotapolyphenolpolymedicationinflammationobesitydiabeteshypertensionhyperlipidemiaurolithins

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    Changes from baseline at 30 days vs placebo

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

    Changes from baseline at 30 days vs placebo

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

    Changes from baseline at 30 days vs placebo

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

    Changes from baseline at 30 days vs placebo

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

    Changes from baseline at 30 days vs placebo

  • +1 more secondary outcomes

Study Arms (4)

Pomegranate extract-1

EXPERIMENTAL

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

Dietary Supplement: Pomegranate extract

Placebo-1

PLACEBO COMPARATOR

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

Other: Placebo

Placebo-2

PLACEBO COMPARATOR

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

Pomegranate extract-2

EXPERIMENTAL

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

Interventions

Pomegranate extractDIETARY_SUPPLEMENT

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

Pomegranate extract-1Pomegranate extract-2
PlaceboOTHER

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

Placebo-1Placebo-2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Age under 18 years
  • Pregnancy or breastfeeding
  • Pomegranate allergy or intolerance (known or suspected)
  • Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
  • Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish National Research Council (CSIC)

Murcia, 30100, Spain

Location

MeSH Terms

Conditions

Metabolic SyndromeInflammationObesityDiabetes MellitusHypertensionHyperlipidemias

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism Disorders

Study Officials

  • Juan C Espín, PhD

    Spanish National Research Council (CSIC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, double-blind, placebo-controlled and crossover trial.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 30, 2019

Study Start

June 10, 2018

Primary Completion

July 21, 2019

Study Completion

December 31, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

ES(1)