BACKGROUND: We are aware of no study that has indicated the effects of daily consumption of multispecies probiotic supplements on metabolic profiles, high-sensitivity C-reactive protein (hs-CRP), and oxidative stress in diabetic patients. OBJECTIVE: This study was designed to determine the effects of multispecies probiotic supplements on metabolic profiles, hs-CRP, and oxidative stress in diabetic patients. METHODS: This randomized double-blind placebo-controlled clinical trial was performed on 54 diabetic patients aged 35-70 years. Subjects were randomly assigned to take either a multispecies probiotic supplement (n = 27) or placebo (n = 27) for 8 weeks. The multispecies probiotic supplement consisted of 7 viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) CFU), L. casei (7 × 10(9) CFU), L. rhamnosus (1.5 × 10(9) CFU), L. bulgaricus (2 × 10(8) CFU), Bifidobacterium breve (2 × 10(10) CFU), B. longum (7 × 10(9) CFU), Streptococcus thermophilus (1.5 × 10(9) CFU), and 100 mg fructo-oligosaccharide. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles, hs-CRP, and biomarkers of oxidative stress including plasma total antioxidant capacity and total glutathione (GSH). RESULTS: Between-group comparisons of fasting plasma glucose (FPG) revealed that consumption of probiotic supplements prevented a rise in FPG (+28.8 ± 8.5 for placebo vs. +1.6 ± 6 mg/dl for probiotic group, p = 0.01). Although a significant within-group increase in serum insulin and low-density lipoprotein cholesterol levels was found in both the probiotic group and the placebo group, the changes were similar between the two groups. We observed a significant increase in HOMA-IR (homeostasis model of assessment-insulin resistance) in both the probiotic group (p = 0.02) and the placebo group (p = 0.001); however, the increase in the placebo group was significantly higher than that in the probiotic group (+2.38 vs. +0.78, p = 0.03). Mean changes in serum hs-CRP were significantly different between the two groups (-777.57 for the probiotic group vs. +878.72 ng/ml for the placebo group, p = 0.02). Probiotic supplementation led to a significant increase in plasma GSH levels compared to placebo (240.63 vs. -33.46 µmol/l, p = 0.03). CONCLUSION: In conclusion, multispecies probiotic supplementation, compared with placebo, for 8 weeks in diabetic patients prevented a rise in FPG and resulted in a decrease in serum hs-CRP and an increase in plasma total GSH.
RCT Entities:
BACKGROUND: We are aware of no study that has indicated the effects of daily consumption of multispecies probiotic supplements on metabolic profiles, high-sensitivity C-reactive protein (hs-CRP), and oxidative stress in diabeticpatients. OBJECTIVE: This study was designed to determine the effects of multispecies probiotic supplements on metabolic profiles, hs-CRP, and oxidative stress in diabeticpatients. METHODS: This randomized double-blind placebo-controlled clinical trial was performed on 54 diabeticpatients aged 35-70 years. Subjects were randomly assigned to take either a multispecies probiotic supplement (n = 27) or placebo (n = 27) for 8 weeks. The multispecies probiotic supplement consisted of 7 viable and freeze-dried strains: Lactobacillus acidophilus (2 × 10(9) CFU), L. casei (7 × 10(9) CFU), L. rhamnosus (1.5 × 10(9) CFU), L. bulgaricus (2 × 10(8) CFU), Bifidobacterium breve (2 × 10(10) CFU), B. longum (7 × 10(9) CFU), Streptococcus thermophilus (1.5 × 10(9) CFU), and 100 mg fructo-oligosaccharide. Fasting blood samples were taken at baseline and after intervention to measure metabolic profiles, hs-CRP, and biomarkers of oxidative stress including plasma total antioxidant capacity and total glutathione (GSH). RESULTS: Between-group comparisons of fasting plasma glucose (FPG) revealed that consumption of probiotic supplements prevented a rise in FPG (+28.8 ± 8.5 for placebo vs. +1.6 ± 6 mg/dl for probiotic group, p = 0.01). Although a significant within-group increase in serum insulin and low-density lipoprotein cholesterol levels was found in both the probiotic group and the placebo group, the changes were similar between the two groups. We observed a significant increase in HOMA-IR (homeostasis model of assessment-insulin resistance) in both the probiotic group (p = 0.02) and the placebo group (p = 0.001); however, the increase in the placebo group was significantly higher than that in the probiotic group (+2.38 vs. +0.78, p = 0.03). Mean changes in serum hs-CRP were significantly different between the two groups (-777.57 for the probiotic group vs. +878.72 ng/ml for the placebo group, p = 0.02). Probiotic supplementation led to a significant increase in plasma GSH levels compared to placebo (240.63 vs. -33.46 µmol/l, p = 0.03). CONCLUSION: In conclusion, multispecies probiotic supplementation, compared with placebo, for 8 weeks in diabeticpatients prevented a rise in FPG and resulted in a decrease in serum hs-CRP and an increase in plasma total GSH.