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The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial

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Abstract

Aims

Probiotics and/or prebiotics could be a promising approach to improve metabolic disorders by favorably modifying the gut microbial composition.

Objectives

To assess the effects of probiotics and synbiotic on glycemic indices in prediabetic individuals who are at risk of type 2 diabetes and its complications.

Methods

In a double-blind, randomized, placebo-controlled parallel-group clinical trial, 120 prediabetic adults participated and were randomly allocated to receive either probiotics or synbiotic or placebo supplements for 24 weeks. Anthropometric measurements, food record, physical activity and glycemic biomarkers including glycated hemoglobin (HbA1C), fasting plasma glucose (FPG), fasting insulin levels (FIL), homoeostasis model assessment for insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and β-cell function (HOMA-B) were assessed at baseline and repeated at 12 and 24 weeks and compared within and between three groups using repeated measure ANOVA.

Results

Compared with the placebo, synbiotic supplementation resulted in a higher significant reduction in FPG (− 6.5 ± 1.6 vs. − 0.82 ± 1.7 mg/dL, P = 0.01), FIL (− 2.6 ± 0.9 vs. − 0.8 ± 0.8 µIU/mL, P = 0.028), and HOMA-IR (− 0.86 ± 0.3 vs. − 0.16 ± 0.25, P = 0.007), and a significant elevation in the QUICKI (+ 0.01 ± 0.003 vs. + 0.003 ± 0.002, P = 0.006). In addition, significant decreases in HbA1C was seen following the supplementation of probiotics and synbiotic compared with the placebo (− 0.12 ± 0.06 and − 0.14 ± 0.05 vs. +0.07 ± 0.06%, P = 0.005 and 0.008, respectively). HOMA-B was not found to be different between or within the three groups.

Conclusion

Glycemic improvement by probiotics and particularly synbiotic supplements in prediabetic individuals has been supported by current study. However, further studies are required for optimal recommendations in this important area of patient treatment.

Trial registration

Iranian Registry of Clinical Trials: IRCT201511032321N2, Date registered February 27, 2016.

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Acknowledgements

We would like to thank the study participants for their time and cooperation and the Endocrine and Metabolism Research Center stuff for their collaboration.

Funding

This project was funded by the Isfahan University of Medical Sciences. The funding body played no role in the design, collection, and analysis, interpretation of data, writing of the manuscript or the decision to submit the manuscript for publication.

Author information

Authors and Affiliations

  1. Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Sedighe Tahere Research Complex, Khoram St., Isfahan, Iran

    Nazila Kassaian, Ashraf Aminorroaya & Masoud Amini

  2. Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran

    Awat Feizi

  3. Microbiology Department, Science Faculty, Islamic Azad University (IAU), Arak Branch, Arak, Iran

    Parvaneh Jafari

  4. Microbiology Department, Science Faculty, Islamic Azad University (IAU), Tehran Central Branch, Tehran, Iran

    Maryam Tajabadi Ebrahimi

Authors
  1. Nazila Kassaian
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  2. Awat Feizi
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  3. Ashraf Aminorroaya
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  4. Parvaneh Jafari
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  5. Maryam Tajabadi Ebrahimi
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  6. Masoud Amini
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Contributions

MA, AA, AF, and NK conceptualized the study and are the writing group. NK, MTE, and PJ were main researchers. AF and NK developed the statistical design and analysis. All of the authors have seen and approved the final version of the manuscript.

Corresponding author

Correspondence to Masoud Amini.

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Conflict of interest

The authors declare no other competing interests.

Ethical approval

This study has been reviewed by the ethics committee of Isfahan University of Medical Sciences and was in accordance with the ethical standards in the last version of Declaration of Helsinky.

Informed consent

All persons gave their informed consent prior to inclusion in the study.

Additional information

Managed by Antonio Secchi.

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Kassaian, N., Feizi, A., Aminorroaya, A. et al. The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial. Acta Diabetol 55, 1019–1028 (2018). https://doi.org/10.1007/s00592-018-1175-2

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  • DOI: https://doi.org/10.1007/s00592-018-1175-2

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