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The effects of probiotics supplements on metabolic indices and clinical signs in patients with diabetic retinopathy, a randomized double blind clinical trial

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Abstract

Purpose

This study was carried out to evaluate the effects of probiotics administration on clinical status and metabolic profiles in diabetic retinopathy (DR) patients.

Methods

This randomized, double-blind, placebo-controlled trial was conducted among 72 DR patients. Subjects received probiotics including Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium langum, Bifidobacterium lactis daily (2 × 109 CFU/each strain) (n = 36) or placebo (starch) (n = 36) and were instructed to take one capsule daily for 12 weeks. Finally, 55 participants [probiotic group (n = 30) and placebo group (n = 25)] completed the study. Fasting blood samples were obtained at baseline and after the 12-week intervention to determine metabolic profiles. To determine the effects of probiotic supplementation on clinical symptoms and biochemical variables, we used one-way repeated measures analysis of variance.

Results

After the 12-week intervention, compared with the placebo, probiotic supplementation significantly decreased means serum insulin concentrations (Probiotic group: -4.9 ± 6.5vs. Placebo group: 3.0 ± 7.7 µIU/mL, Ptime×group<0.001), homeostatic model assessment for insulin resistance (Probiotic group: -2.5 ± 3.8 vs. Placebo group: 1.1 ± 2.7, Ptime×group<0.001) and hemoglobin A1c (HbA1C) (Probiotic group: -0.4 ± 0.7 vs. Placebo group: -0.02 ± 0.2%, Ptime×group=0.01), and significantly increased the quantitative insulin sensitivity check index (QUICKI) (Probiotic group: 0.02 ± 0.03 vs. Placebo group: -0.03 ± 0.04, Ptime×group<0.001). There was no significant effect of probiotic administration on other metabolic profiles and clinical symptoms.

Conclusions

Overall, probiotic supplementation after 12 weeks in DR patients had beneficial effects on few metabolic profiles. This study was registered under the Iranian website for clinical trials as http://www.irct.ir: IRCT20130211012438N29.

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Data availability

The primary data for this study is available from the authors on direct request.

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Funding

The Research Deputy of Kashan University of Medical Sciences (KAUMS) gave this study grant.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, School of Medicine, Matini Hospital, Kashan University of Medical Sciences, Kashan, Iran

    Hasan Farajipour

  2. School of Medicine, Kashan University of Medical Sciences, Kashan, Iran

    Hamid Reza Matin & Saeed Sadr

  3. Faculty member of Science Department, Science Faculty, Islamic Azad University, Tehran Central branch, Tehran, Iran

    Zatollah Asemi & Maryam Tajabadi-Ebrahimi

  4. Research Center for Biochemistry and Nutrition in Metabolic Diseases, Institute for Basic Sciences, Kashan University of Medical Sciences, Kashan, Iran

    Nasrin Sharifi, Zarrin Banikazemi, Mohsen Taghizadeh & Hamed Mirzaei

  5. Student Research Committee, Kashan University of Medical Sciences, Kashan, Iran

    Zarrin Banikazemi

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  1. Hasan Farajipour
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Contributions

MT and HM: Concept, statistical analysis, design, drafting the paper, and supervising the research. HF, HM, ZA, SS, MT-E, NSH, and ZB: Collecting the data and drafting the trial.

Corresponding authors

Correspondence to Mohsen Taghizadeh or Hamed Mirzaei.

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The authors declare no conflict of interest.

Registration number of the clinical trial

http://www.irct.ir: IRCT20130211012438N29.

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Farajipour, H., Matin, H.R., Asemi, Z. et al. The effects of probiotics supplements on metabolic indices and clinical signs in patients with diabetic retinopathy, a randomized double blind clinical trial. J Diabetes Metab Disord (2024). https://doi.org/10.1007/s40200-024-01399-2

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  • DOI: https://doi.org/10.1007/s40200-024-01399-2

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