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

University of Banja Luka60 enrolled

Overview

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.

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 \[DRAFT\] -

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

Polyphenols of pomegranate fruit peel extract (PoPex)DIETARY_SUPPLEMENT

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.

PlaceboDRUG

Placebo in form of capsule will be orally administered in subjects with metabolic syndrome and obesity over 8 weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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: 1. TG ≥ 1,7 mmol/l, or present therapy for dyslipidemia 2. HDL \<1,03 mmol/l men, \<1,29 mmol/l women 3. Arterial blood pressure ≥130/85 mmHg 4. 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

Locations (1)

Public Health Institution Dom zdravlja Banja Luka

Banja Luka, Republika Srpska, Bosnia and Herzegovina

Outcomes

Primary Outcomes

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

Time frame: From Baseline and after 8 weeks

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

Time frame: From Baseline and after 8 weeks

Change in antiinflammatori parametars:interleukin -5 (IL-5) ,interleukin-10(IL-10), interleukin-12 (IL-12) ,adiponectin and omentin

ELISA assey

Time frame: From Baseline and after 8 weeks

Secondary Outcomes

Change in inflammation marker level : high sensitivity CRP Turbid mertic test

Turbid metric test

Time frame: From Baseline and after 8 weeks

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

Time frame: From Baseline,after 4 and 8 weeks

Change in serum levels homocystein

Detection by fluoroscence polarization immunoassay

Time frame: From Baseline,after 4 and 8 weeks

Change in serum levels of vitamin B6-piridoxin ,vitamin B9-folic acid ,vitamin B12-cianocobalamin

Microparticle enzyme immunoassey

Data from ClinicalTrials.gov

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