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The Effects of Probiotic Honey Consumption on Metabolic Status in Patients with Diabetic Nephropathy: a Randomized, Double-Blind, Controlled Trial

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08 September 2020 Editor's Note: The Editor-in-Chief is currently investigating this article as concerns have been raised about integrity of the clinical trial reported here. There is also an ongoing investigation by the Iranian National Committee for Ethics in Biomedical Researches. Further editorial action will be taken as appropriate once the investigation into the concerns is complete and all parties have been given an opportunity to respond in full.

Abstract

To the best of our knowledge, this study is the first evaluating the effects of probiotic honey intake on glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress in patients with diabetic nephropathy (DN). This investigation was conducted to evaluate the effects of probiotic honey intake on metabolic status in patients with DN. This randomized, double-blind, controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 25 g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11 (IBRC-M10791) (108 CFU/g) or 25 g/day control honey (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and 12 weeks after supplementation to quantify glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress. After 12 weeks of intervention, patients who received probiotic honey compared with the control honey had significantly decreased serum insulin levels (− 1.2 ± 1.8 vs. − 0.1 ± 1.3 μIU/mL, P = 0.004) and homeostasis model of assessment-estimated insulin resistance (− 0.5 ± 0.6 vs. 0.003 ± 0.4, P = 0.002) and significantly improved quantitative insulin sensitivity check index (+ 0.005 ± 0.009 vs. − 0.0007 ± 0.005, P = 0.004). Additionally, compared with the control honey, probiotic honey intake has resulted in a significant reduction in total-/HDL-cholesterol (− 0.2 ± 0.5 vs. + 0.1 ± 0.1, P = 0.04). Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (− 1.9 ± 2.4 vs. − 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (− 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey. Probiotic honey intake had no significant effects on other metabolic profiles compared with the control honey. Overall, findings from the current study demonstrated that probiotic honey consumption for 12 weeks among DN patients had beneficial effects on insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels, but did not affect other metabolic profiles. http://www.irct.ir: IRCT201705035623N115.

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  • 08 September 2020

    Editor's Note: The Editor-in-Chief is currently investigating this article as concerns have been raised about integrity of the clinical trial reported here. There is also an ongoing investigation by the Iranian National Committee for Ethics in Biomedical Researches. Further editorial action will be taken as appropriate once the investigation into the concerns is complete and all parties have been given an opportunity to respond in full.

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Acknowledgements

The present study was supported by a grant from the Vice-chancellor for Research, KAUMS, and Iran. Special thanks to Gaz Sekkeh Company for providing probiotic and control honey.

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NM-A and ZA contributed in conception, data collection, and manuscript drafting. ZE-D, HT, RS-C, and AS contributed in conception, data collection, and manuscript drafting. All authors read and approved the final version of the paper.

Corresponding author

Correspondence to Zatollah Asemi.

Ethics declarations

This investigation was conducted in accordance with the Declaration of Helsinki. The informed written consent was taken from all enrolled patients, with ethical clearance for the study obtained from the ethics committee of Kashan University of Medical Sciences (KAUMS).

Conflicts of Interest

The authors declare that they have no conflict of interest.

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Mazruei Arani, N., Emam-Djomeh, Z., Tavakolipour, H. et al. The Effects of Probiotic Honey Consumption on Metabolic Status in Patients with Diabetic Nephropathy: a Randomized, Double-Blind, Controlled Trial. Probiotics & Antimicro. Prot. 11, 1195–1201 (2019). https://doi.org/10.1007/s12602-018-9468-x

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