Clinical trial NCT05915117: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Inflamation
Oxidative stress
Obesity
Polyphenols of Pomegranate Fruit Peel Extract
Lead sponsor: University of Banja Luka
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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:

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

Primary outcomes:
measure: 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).
timeFrame: From Baseline and after 8 weeks
measure: 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
timeFrame: From Baseline and after 8 weeks
measure: Change in antiinflammatori parametars:interleukin -5 (IL-5) ,interleukin-10(IL-10), interleukin-12 (IL-12) ,adiponectin and omentin
timeFrame: From Baseline and after 8 weeks
Secondary outcomes:
measure: Change in inflammation marker level : high sensitivity CRP Turbid mertic test
timeFrame: From Baseline and after 8 weeks
measure: Change in total choleterol (TC), low -density lipoprotein ( LDL), high-density lipoprotein (HDL) and trglicerides Turbid mertic test
timeFrame: From Baseline,after 4 and 8 weeks
measure: Change in serum levels homocystein
timeFrame: From Baseline,after 4 and 8 weeks
measure: Change in serum levels of vitamin B6-piridoxin ,vitamin B9-folic acid ,vitamin B12-cianocobalamin
timeFrame: From Baseline, after 4 and 8 weeks
measure: Change in serum levels of glycemia, insulinemia
timeFrame: From Baseline,after 4 and after 8 weeks
measure: Change in serum levels of liver function tests
timeFrame: From Baseline,after 4 and after 8 weeks
measure: Change in body weight
timeFrame: From Baseline and after 8 weeks
measure: Change in systolic and diastolic blood presure
timeFrame: From Baseline and after 8 weeks
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Public Health Institution Dom zdravlja Banja Luka
state: Republic Of Srpska
Study officials:
affiliation: University of Banja Luka
name: Ranko Škrbić, Professor
role: STUDY_CHAIR
References:
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.