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

NCT05915117 | Unknown

• 1 other identifier: PoPexMetSy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Inflamation; Oxidative stress; Obesity; Polyphenols of Pomegranate Fruit Peel Extract

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  From Baseline and after 8 weeks

Secondary Outcomes (8)

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

  From Baseline and after 8 weeks

• Change in total choleterol (TC), low -density lipoprotein ( LDL), high-density lipoprotein (HDL) and trglicerides Turbid mertic test

  From Baseline,after 4 and 8 weeks

• Change in serum levels homocystein

  From Baseline,after 4 and 8 weeks

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

  From Baseline, after 4 and 8 weeks

• Change in serum levels of glycemia, insulinemia

  From Baseline,after 4 and after 8 weeks

Study Arms (2)

Polyphenols of pomegranate fruit peel extract (PoPex)

EXPERIMENTAL

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

Dietary Supplement: Polyphenols of pomegranate fruit peel extract (PoPex)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Also known as: Granat

Polyphenols of pomegranate fruit peel extract (PoPex)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Banja Luka: lead

Study Sites (1)

Public Health Institution Dom zdravlja Banja Luka

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

Related Publications (1)

• 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.

  PMID: 35229548 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ranko Škrbić, Professor

  University of Banja Luka

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: April 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: August 20, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)