NCT05915117

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Banja Luka · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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 \[DRAFT\] -

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polyphenols of pomegranate fruit peel extract (PoPex)	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.
DRUG	Placebo	Placebo in form of capsule will be orally administered in subjects with metabolic syndrome and obesity over 8 weeks.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-20
• Completion: 2024-08-20
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: Bosnia and Herzegovina