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
Authors
Grabež, MilkicaŠkrbić, Ranko
Stojiljković, Miloš P.
Vučić, Vesna M.

Grujić, Vesna Rudić
Jakovljević, Vladimir
Đurić, Dragan M.
Suručić, Relja
Šavikin, Katarina

Bigović, Dubravka
Vasiljević, Nađa
Article (Published version)
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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.
Keywords:
pomegranate peel extract / polyphenols / oxidative stress / inflammation / lipid profile / diabetes mellitusSource:
Reviews in Cardiovascular Medicine, 2022, 23, 2, 57-Publisher:
- IMR Press
Funding / projects:
- Ministry for Scientific-Technological Development, Higher Education and Information Society (No 19/6-020/961-81/18) Government of the Republic of Srpska
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Institut za medicinska istraživanjaTY - JOUR AU - Grabež, Milkica AU - Škrbić, Ranko AU - Stojiljković, Miloš P. AU - Vučić, Vesna M. AU - Grujić, Vesna Rudić AU - Jakovljević, Vladimir AU - Đurić, Dragan M. AU - Suručić, Relja AU - Šavikin, Katarina AU - Bigović, Dubravka AU - Vasiljević, Nađa PY - 2022 UR - http://rimi.imi.bg.ac.rs/handle/123456789/1217 AB - 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. T2 - Reviews in Cardiovascular Medicine T2 - Reviews in Cardiovascular Medicine T1 - 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 IS - 2 SP - 57 VL - 23 DO - 10.31083/j.rcm2302057 ER -
@article{ author = "Grabež, Milkica and Škrbić, Ranko and Stojiljković, Miloš P. and Vučić, Vesna M. and Grujić, Vesna Rudić and Jakovljević, Vladimir and Đurić, Dragan M. and Suručić, Relja and Šavikin, Katarina and Bigović, Dubravka and Vasiljević, Nađa", year = "2022", abstract = "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.", journal = "Reviews in Cardiovascular Medicine, Reviews in Cardiovascular Medicine", title = "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", number = "2", pages = "57", volume = "23", doi = "10.31083/j.rcm2302057" }
Grabež, M., Škrbić, R., Stojiljković, M. P., Vučić, V. M., Grujić, V. R., Jakovljević, V., Đurić, D. M., Suručić, R., Šavikin, K., Bigović, D.,& Vasiljević, N.. (2022). 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. in Reviews in Cardiovascular Medicine, 23(2), 57. https://doi.org/10.31083/j.rcm2302057
Grabež M, Škrbić R, Stojiljković MP, Vučić VM, Grujić VR, Jakovljević V, Đurić DM, Suručić R, Šavikin K, Bigović D, Vasiljević 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. in Reviews in Cardiovascular Medicine. 2022;23(2):57. doi:10.31083/j.rcm2302057 .
Grabež, Milkica, Škrbić, Ranko, Stojiljković, Miloš P., Vučić, Vesna M., Grujić, Vesna Rudić, Jakovljević, Vladimir, Đurić, Dragan M., Suručić, Relja, Šavikin, Katarina, Bigović, Dubravka, Vasiljević, Nađa, "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" in Reviews in Cardiovascular Medicine, 23, no. 2 (2022):57, https://doi.org/10.31083/j.rcm2302057 . .