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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

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2022
Prospective_Randomized_Double-Blind_Placebo-Controlled_pub_2022.pdf (588.7Kb)
Authors
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
Article (Published version)
Metadata
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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.

Keywords:
pomegranate peel extract / polyphenols / oxidative stress / inflammation / lipid profile / diabetes mellitus
Source:
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

DOI: 10.31083/j.rcm2302057

ISSN: 1530-6550

[ Google Scholar ]
URI
http://rimi.imi.bg.ac.rs/handle/123456789/1217
Collections
  • Radovi istraživača / Researchers' publications
Institution/Community
Institut za medicinska istraživanja
TY  - 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 . .

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