The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial
This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 109 CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (β − 13.56 mg/dL; 95% CI, − 23.82, − 3.30; P = 0.01), insulin levels (β − 5.49 μIU/mL; 95% CI, − 6.92, − 4.05; P < 0.001), and insulin resistance (β − 2.25; 95% CI, − 3.02, − 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (β 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (β − 2930.48 ng/mL; 95% CI, − 3741.15, − 2119.80; P < 0.001) and malondialdehyde levels (β − 0.60 μmol/L; 95% CI, − 0.99, − 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (β 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (β 131.11 μmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.
KeywordsSynbiotic supplementation Diabetes Hemodialysis Metabolic status
end-stage renal disease
fasting plasma glucose
homeostasis model of assessment-insulin resistance
high-sensitivity C-reactive protein
quantitative insulin sensitivity check index
short-chain fatty acids
subjective global assessment
type 2 diabetes mellitus
total antioxidant capacity
The present study was supported by a grant from the Vice-chancellor for Research, KAUMS, and Iran. The authors would like to thank the staff of Akhavan Clinic (Kashan, Iran) for their assistance in this project. The authors of this study would like to appreciate Dr. Naghmeh Mirhosseini for a scientific review and edition of the paper.
ZA: Conception, design, and statistical analysis, drafting of the manuscript, and supervised the study.
AS, AM, MZ-M, FB, EA, VO, and MT-E: data collection and manuscript drafting.
The research grant provided by Research Deputy of Kashan University of Medical Sciences (KAUMS).
Compliance with Ethical Standards
Ethics Approval and Consent to Participate
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments.
Consent for Publication
Availability of Data and Material
The primary data for this study is available from the authors on direct request.
The authors declare that they have no conflict of interest.
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