Metabolic Syndrome
Conditions
Keywords
Metabolic syndrome, Inflamation, Oxidative stress, Obesity, Polyphenols of Pomegranate Fruit Peel Extract
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. \- Page 2 of 6 \[DRAFT\] -
Interventions
DIETARY_SUPPLEMENTPolyphenols 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.
DRUGPlacebo
Placebo in form of capsule will be orally administered in subjects with metabolic syndrome and obesity over 8 weeks.
Sponsors
University of Banja Luka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | From Baseline and after 8 weeks | ELISA assey |
| 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 | 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 | From Baseline and after 8 weeks | ELISA assey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum levels of vitamin B6-piridoxin ,vitamin B9-folic acid ,vitamin B12-cianocobalamin | From Baseline, after 4 and 8 weeks | Microparticle enzyme immunoassey |
| Change in serum levels of glycemia, insulinemia | From Baseline,after 4 and after 8 weeks | glycemia-hexokinase method,insulinemia-ultrasensitivity test,immunoenzyme test:sandwich |
| Change in inflammation marker level : high sensitivity CRP Turbid mertic test | From Baseline and after 8 weeks | Turbid metric test |
| Change in body weight | From Baseline and after 8 weeks | weight ( kg) |
| Change in systolic and diastolic blood presure | From Baseline and after 8 weeks | mm/HG |
| Change in serum levels of liver function tests | From Baseline,after 4 and after 8 weeks | IFCC,reference method with pyridoxyl phosphate |
| 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 | Clinical biochemistry (colorimetric) test and results will be expressed in mmol/l |
| Change in serum levels homocystein | From Baseline,after 4 and 8 weeks | Detection by fluoroscence polarization immunoassay |
Countries
Bosnia and Herzegovina
Outcome results
None listed