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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Polyphenols of pomegranate fruit peel extract (PoPex)
All subjects will treated only with PoPex in total daily dosis of 500 mg/orally over 8 weeks.
Intervention: Polyphenols of pomegranate fruit peel extract (PoPex) (Dietary Supplement)
Placebo
All subjects will treated only with PoPex placebo capsules/orally over 8 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Time Frame: From Baseline and after 8 weeks
ELISA assey
Change in antiinflammatori parametars:interleukin -5 (IL-5) ,interleukin-10(IL-10), interleukin-12 (IL-12) ,adiponectin and omentin
Time Frame: From Baseline and after 8 weeks
ELISA assey
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).
Time Frame: From Baseline and after 8 weeks
ELISA assey
Secondary Outcomes
- 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 liver function tests(From Baseline,after 4 and after 8 weeks)
- Change in systolic and diastolic blood presure(From Baseline and after 8 weeks)
- Change in inflammation marker level : high sensitivity CRP Turbid mertic test(From Baseline and after 8 weeks)
- Change in body weight(From Baseline and after 8 weeks)
- Change in serum levels homocystein(From Baseline,after 4 and 8 weeks)
- Change in serum levels of glycemia, insulinemia(From Baseline,after 4 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)