Milkica Grabež1,2, Ranko Škrbić3, Miloš P Stojiljković3, Vesna Vučić4, Vesna Rudić Grujić1,2, Vladimir Jakovljević5,6, Dragan M Djuric7, Relja Suručić8, Katarina Šavikin9, Dubravka Bigović9, Nađa Vasiljević10. 1. Department of Hygiene, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina. 2. Department of Hygiene, Public Health Institute of Republic of Srpska, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina. 3. Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina. 4. Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research University of Belgrade, 11000 Beograd, Serbia. 5. Department of Physiology, Faculty of Medical Sciences University of Kragujevac, 34000 Kragujevac, Serbia. 6. Department of Human Pathology, 1st Moscow Medical University "I.M. Sechenov", 119991 Moscow, Russian Federation. 7. Institute of Medical Physiology "Richard Burian", Faculty of Medicine University of Belgrade, 11000 Belgrade, Serbia. 8. Department of Pharmacоgnosy, Faculty of Medicine University of Banja Luka, 78000 Banja Luka, the Republic of Srpska, Bosnia & Herzegovina. 9. Institute for Medicinal Plant Research "Dr Josif Pančić", 11000 Belgrade, Serbia. 10. Institute of Hygiene and Medical Ecology, Faculty of Medicine University of Belgrade, 11000 Belgrade, Serbia.
Abstract
BACKGROUND: Type 2 diabetes mellitus (T2DM) is commonly associated with hyperglycemia, dyslipidemia, oxidative stress and inflammation which are well known cardiovascular risk factors. Pomegranate peel polyphenols have a proven hypolipemic, antioxidant and anti-inflammatory activity. However, there is a lack of clinical studies that would confirm its antioxidant and anti-inflammatory effects in diabetic patients. The potential of pomegranate peel extract (PoPEx) to counteract inflammation and oxidative stress in T2DM patients was investigated. For this purpose, a randomized, double-blind placebo-controlled study involving adult T2DM patients treated with PoPEx or placebo for eight-weeks was conducted. METHODS: Patients were randomly divided into two groups: the first group (n = 30) received capsules containing PoPEx 250 mg twice daily, while the placebo group (n = 30) received placebo capsules twice daily. Plasma concentration of inflammatory factors (interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) and high sensitivity C reactive protein (hsCRP)), oxidative stress biomarkers (thiobarbituric acid reactive substances (TBARS), nitrites (NO2-), superoxide anion radical (O2-), hydrogen peroxide (H2O2), total antioxidant capacity (TAC)), homocysteine and lipid profile were analyzed. RESULTS: The PoPEx treatment showed a significant reduction of inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC was increased. Moreover, a significant improvement in lipid profile was observed in the PoPEx group. Additional analysis showed a significant inverse correlation between the decrements of all measured inflammatory markers and TAC in the PoPEx group. CONCLUSIONS: The study demonstrated that eight-week-long PoPEx administration had favorable effects on inflammatory status and oxidative stress biomarkers in diabetic patients.
BACKGROUND: Type 2 diabetes mellitus (T2DM) is commonly associated with hyperglycemia, dyslipidemia, oxidative stress and inflammation which are well known cardiovascular risk factors. Pomegranate peel polyphenols have a proven hypolipemic, antioxidant and anti-inflammatory activity. However, there is a lack of clinical studies that would confirm its antioxidant and anti-inflammatory effects in diabetic patients. The potential of pomegranate peel extract (PoPEx) to counteract inflammation and oxidative stress in T2DM patients was investigated. For this purpose, a randomized, double-blind placebo-controlled study involving adult T2DM patients treated with PoPEx or placebo for eight-weeks was conducted. METHODS: Patients were randomly divided into two groups: the first group (n = 30) received capsules containing PoPEx 250 mg twice daily, while the placebo group (n = 30) received placebo capsules twice daily. Plasma concentration of inflammatory factors (interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) and high sensitivity C reactive protein (hsCRP)), oxidative stress biomarkers (thiobarbituric acid reactive substances (TBARS), nitrites (NO2-), superoxide anion radical (O2-), hydrogen peroxide (H2O2), total antioxidant capacity (TAC)), homocysteine and lipid profile were analyzed. RESULTS: The PoPEx treatment showed a significant reduction of inflammatory factors (IL-6, TNF-α, hsCRP), oxidative stress biomarkers (TBARS, NO2-, O2-) and homocysteine, while the TAC was increased. Moreover, a significant improvement in lipid profile was observed in the PoPEx group. Additional analysis showed a significant inverse correlation between the decrements of all measured inflammatory markers and TAC in the PoPEx group. CONCLUSIONS: The study demonstrated that eight-week-long PoPEx administration had favorable effects on inflammatory status and oxidative stress biomarkers in diabetic patients.