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Effects of Polyphenols of Pomegranate Fruit Peel Extract on Inflammation and Oxidative Stress in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Active
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Polyphenols of pomegranate fruit peel extract (PoPex)
Placebo
Sponsored by
University of Banja Luka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Inflamation, Oxidative stress, Obesity, Polyphenols of Pomegranate Fruit Peel Extract

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent signed Adults of 20 to 60 years BMI ≥ 25.00 kg/m2 Met criteria for metabolic syndrome such as visceral obesity( for men ≥ 94 cm and ≥ 80 cm for women) and at least two risk factors: TG ≥ 1,7 mmol/l, or present therapy for dyslipidemia HDL <1,03 mmol/l men, <1,29 mmol/l women Arterial blood pressure ≥130/85 mmHg Glycemia ≥ 5.6 mmol/l and < 6.9 mmol/l Exclusion Criteria: Subjects with malignant and other acute and chronic infectious and non-infectious disease requiring active pharmacotherapy. Subjects with with insulin dependent diabetes mellitus or subjects with insulin independent diabetes mellitus taking oral hypoglycemic therapy Subjects with uncontrolled chronic cardiovascular, endocrine, autoimmune, psychiatric, and autoimmune diseases or other condition based on the investigator judgement. Non adherent subject Systematic use of corticosteroids Pregnant or lactating women Chronic use of supplements (omega 3 unsaturated acids, silymarin, mineral-vitamin supplements) Participation in any other interventional study

Sites / Locations

  • Public Health Institution Dom zdravlja Banja Luka

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyphenols of pomegranate fruit peel extract (PoPex)

Placebo

Arm Description

All subjects will treated only with PoPex in total daily dosis of 500 mg/orally over 8 weeks.

All subjects will treated only with PoPex placebo capsules/orally over 8 weeks

Outcomes

Primary Outcome Measures

Change in oxidative stress biomarkers levels: lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and glutation (GSH), catalasis(CAT) and superoxid dismutasis(SOD).
ELISA assey
Change in proinflammatori parametars:interleukin-6 (IL-6), tumor necrosis factor-α (TNF- α), high sensitive CRP (hsCRP), leptin, resistin ,vaspin, chemerin ,lipokalin -2 and katepsin
ELISA assey
Change in antiinflammatori parametars:interleukin -5 (IL-5) ,interleukin-10(IL-10), interleukin-12 (IL-12) ,adiponectin and omentin
ELISA assey

Secondary Outcome Measures

Change in inflammation marker level : high sensitivity CRP Turbid mertic test
Turbid metric test
Change in total choleterol (TC), low -density lipoprotein ( LDL), high-density lipoprotein (HDL) and trglicerides Turbid mertic test
Clinical biochemistry (colorimetric) test and results will be expressed in mmol/l
Change in serum levels homocystein
Detection by fluoroscence polarization immunoassay
Change in serum levels of vitamin B6-piridoxin ,vitamin B9-folic acid ,vitamin B12-cianocobalamin
Microparticle enzyme immunoassey
Change in serum levels of glycemia, insulinemia
glycemia-hexokinase method,insulinemia-ultrasensitivity test,immunoenzyme test:"sandwich"
Change in serum levels of liver function tests
IFCC,reference method with pyridoxyl phosphate
Change in body weight
weight ( kg)
Change in systolic and diastolic blood presure
mm/HG

Full Information

First Posted
June 13, 2023
Last Updated
June 13, 2023
Sponsor
University of Banja Luka
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1. Study Identification

Unique Protocol Identification Number
NCT05915117
Brief Title
Effects of Polyphenols of Pomegranate Fruit Peel Extract on Inflammation and Oxidative Stress in Metabolic Syndrome
Official Title
Randomized, Double-blind, Placebo-controlled Study of Efficacy Polyphenols of Pomegranate Fruit Peel Extract on Inflammatory Parameters and Oxidative Stress in Overweight and Obese Subjects With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Banja Luka

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 purpose of this study is to evaluate the effects of polyphenols of pomegranate fruit peel extract compared to placebo on oxidative stress and inflammation in overweight and obese subjects with metabolic syndrome.
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled evaluation of the efficacy of polyphenols of pomegranate fruit peel extract on oxidative stress and inflammation in overweight and obese subjects with metabolic syndrome. Study site: a single study center (Primary Health Care Institution in Banja Luka, as recruiter center) as recruitment center including Center for Biomedical Research, Faculty of Medicine University of Banja Luka, as local laboratory and coordinator. Sample size: 60 subjects, randomized in a 1:1 allocation ratio. Primary objectives are to investigate an effect of polyphenols pomegranate fruit peel extract on: Anthropometric parameters such as body mass index, and arterial blood pressure, glycemia, lipoprotein profile, homeostatic model assessment for insulin resistance (HOMAIR), homocysteine, vitamin B complex: folic acid, vitamin B6, vitamin B9 and vitamin B12. 2. To investigate the effects polyphenols from pomegranate fruit peel extract has on impact on lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and glutathione (GSH), catalase (CAT) and superoxide dismutase (SOD). 3. Proinflammatory markers interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high sensitive CRP (hsCRP), leptin, resistin ,vaspin, chemerin, lipokalin-2 and katepsin . 4. Anti-infammatory markers IL-5, IL-10, IL-12 ,adiponectin and omentin. Treatments arms: Polyphenols of pomegranate fruit peel extract (PoPeEx) (500 mg/day) Placebo Treatment duration : 8 weeks Assessment - clinical and laboratory sampling: Informed consent and Screening - 7 days prior to randomization Study visits (V): V1 - Randomization and Enrollment (Baseline) V2 - 4 weeks after Baseline V3 - 8 weeks after Baseline. No interim analysis is planned. The analysis will be performed at the end of the study after data review and freezing of the database according to the intent to treat principle. - Page 2 of 6 [DRAFT] -

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, Inflamation, Oxidative stress, Obesity, Polyphenols of Pomegranate Fruit Peel Extract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polyphenols of pomegranate fruit peel extract (PoPex)
Arm Type
Experimental
Arm Description
All subjects will treated only with PoPex in total daily dosis of 500 mg/orally over 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All subjects will treated only with PoPex placebo capsules/orally over 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyphenols of pomegranate fruit peel extract (PoPex)
Other Intervention Name(s)
Granat
Intervention Description
PoPex in form of capsule will be orally administered in total daily dose of 500/mg in subjects with metabolic syndrome and obesity over 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in form of capsule will be orally administered in subjects with metabolic syndrome and obesity over 8 weeks.
Primary Outcome Measure Information:
Title
Change in oxidative stress biomarkers levels: lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and glutation (GSH), catalasis(CAT) and superoxid dismutasis(SOD).
Description
ELISA assey
Time Frame
From Baseline and after 8 weeks
Title
Change in proinflammatori parametars:interleukin-6 (IL-6), tumor necrosis factor-α (TNF- α), high sensitive CRP (hsCRP), leptin, resistin ,vaspin, chemerin ,lipokalin -2 and katepsin
Description
ELISA assey
Time Frame
From Baseline and after 8 weeks
Title
Change in antiinflammatori parametars:interleukin -5 (IL-5) ,interleukin-10(IL-10), interleukin-12 (IL-12) ,adiponectin and omentin
Description
ELISA assey
Time Frame
From Baseline and after 8 weeks
Secondary Outcome Measure Information:
Title
Change in inflammation marker level : high sensitivity CRP Turbid mertic test
Description
Turbid metric test
Time Frame
From Baseline and after 8 weeks
Title
Change in total choleterol (TC), low -density lipoprotein ( LDL), high-density lipoprotein (HDL) and trglicerides Turbid mertic test
Description
Clinical biochemistry (colorimetric) test and results will be expressed in mmol/l
Time Frame
From Baseline,after 4 and 8 weeks
Title
Change in serum levels homocystein
Description
Detection by fluoroscence polarization immunoassay
Time Frame
From Baseline,after 4 and 8 weeks
Title
Change in serum levels of vitamin B6-piridoxin ,vitamin B9-folic acid ,vitamin B12-cianocobalamin
Description
Microparticle enzyme immunoassey
Time Frame
From Baseline, after 4 and 8 weeks
Title
Change in serum levels of glycemia, insulinemia
Description
glycemia-hexokinase method,insulinemia-ultrasensitivity test,immunoenzyme test:"sandwich"
Time Frame
From Baseline,after 4 and after 8 weeks
Title
Change in serum levels of liver function tests
Description
IFCC,reference method with pyridoxyl phosphate
Time Frame
From Baseline,after 4 and after 8 weeks
Title
Change in body weight
Description
weight ( kg)
Time Frame
From Baseline and after 8 weeks
Title
Change in systolic and diastolic blood presure
Description
mm/HG
Time Frame
From Baseline and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent signed Adults of 20 to 60 years BMI ≥ 25.00 kg/m2 Met criteria for metabolic syndrome such as visceral obesity( for men ≥ 94 cm and ≥ 80 cm for women) and at least two risk factors: TG ≥ 1,7 mmol/l, or present therapy for dyslipidemia HDL <1,03 mmol/l men, <1,29 mmol/l women Arterial blood pressure ≥130/85 mmHg Glycemia ≥ 5.6 mmol/l and < 6.9 mmol/l Exclusion Criteria: Subjects with malignant and other acute and chronic infectious and non-infectious disease requiring active pharmacotherapy. Subjects with with insulin dependent diabetes mellitus or subjects with insulin independent diabetes mellitus taking oral hypoglycemic therapy Subjects with uncontrolled chronic cardiovascular, endocrine, autoimmune, psychiatric, and autoimmune diseases or other condition based on the investigator judgement. Non adherent subject Systematic use of corticosteroids Pregnant or lactating women Chronic use of supplements (omega 3 unsaturated acids, silymarin, mineral-vitamin supplements) Participation in any other interventional study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranko Škrbić, Professor
Organizational Affiliation
University of Banja Luka
Official's Role
Study Chair
Facility Information:
Facility Name
Public Health Institution Dom zdravlja Banja Luka
City
Banja Luka
State/Province
Republic Of Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35229548
Citation
Grabez M, Skrbic R, Stojiljkovic MP, Vucic V, Rudic Grujic V, Jakovljevic V, Djuric DM, Surucic R, Savikin K, Bigovic D, Vasiljevic N. A prospective, randomized, double-blind, placebo-controlled trial of polyphenols on the outcomes of inflammatory factors and oxidative stress in patients with type 2 diabetes mellitus. Rev Cardiovasc Med. 2022 Feb 11;23(2):57. doi: 10.31083/j.rcm2302057.
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Effects of Polyphenols of Pomegranate Fruit Peel Extract on Inflammation and Oxidative Stress in Metabolic Syndrome

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