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Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial

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Abstract

Aim

Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation—also refers to multi-strain probiotics—on glycemic control and other diabetes-related outcomes in people with type 2 diabetes.

Design

A randomized, double-blind, parallel-group, controlled clinical trial.

Setting

Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia.

Participants

A total of 136 participants with type 2 diabetes, aged 30–70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks.

Outcomes

Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract.

Statistical analysis

Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate.

Results

With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract.

Conclusion

Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

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Acknowledgments

We gratefully acknowledge the participants and project partners for their enthusiastic support of the study. We thank Universiti Putra Malaysia and B-Crobes Laboratory Sdn. Bhd. for funding this project.

Financial support

This study was funded by internal grant of Universiti Putra Malaysia and research grant of B-Crobes Laboratory Sdn. Bhd. The supplements were provided by “B-Crobes Laboratory Sdn. Bhd.”

Author’s contribution

The authors’ responsibilities were as follows: SF (PhD student) was involved in study conception, study coordination, study conduct, laboratory testing and analysis, statistical analysis and manuscript writing; HAM critically reviewed the manuscript; AI reviewed the manuscript; NAK was involved in administrative coordination; MY B-N served as principle investigator, was involved in study conception and study coordination and reviewed the manuscript. All authors were responsible for the study design.

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Authors and Affiliations

  1. Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia

    Somayyeh Firouzi, Amin Ismail & Mohd-Yusof Barakatun-Nisak

  2. Department of Social and Preventive Medicine, Faculty of Medicine, Centre for Population Health, University of Malaya, Kuala Lumpur, Malaysia

    Hazreen Abdul Majid

  3. Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia

    Nor Azmi Kamaruddin

Authors
  1. Somayyeh Firouzi
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  2. Hazreen Abdul Majid
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  3. Amin Ismail
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  4. Nor Azmi Kamaruddin
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  5. Mohd-Yusof Barakatun-Nisak
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Correspondence to Mohd-Yusof Barakatun-Nisak.

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The authors have nothing to disclose.

Ethical approval

The protocol was approved by the Clinical Research and Ethics Committee of the Universiti Kebangsaan Malaysia Medical Center, conformed to the contents of the 1975 Declaration of Helsinki as revised in 1983, and was registered at the US National Institutes of Health Web site (http://www.clinicaltrials.gov) #NCT01752803.

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Firouzi, S., Majid, H.A., Ismail, A. et al. Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial. Eur J Nutr 56, 1535–1550 (2017). https://doi.org/10.1007/s00394-016-1199-8

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  • DOI: https://doi.org/10.1007/s00394-016-1199-8

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