Cureus · 2024
Efficacy and Safety of F-Biotic™ in Combination With Metformin for Type 2 Diabetes Mellitus: Results From a Randomized, Double-Blind Clinical Trial.
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Devassy Smiju, S Sheejamol, Kumar A K Santhosh, Nair Balprakash
Аннотация
INTRODUCTION: This study evaluated the effectiveness, safety, and tolerability of F-Biotic™ (Arishina Life Sciences, Karnataka, IND), a prebiotic containing 60% resistant starch derived from natural sources, in patients with Type 2 diabetes mellitus (T2DM) on stable metformin therapy.
METHODS: Seventy participants with T2DM, aged 25-70 years, were randomized into two groups: one receiving F-Biotic™ and the other a placebo, both administered daily for 12 weeks. Key outcomes included fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), fasting insulin, insulin resistance (HOMA-IR), GLP-1 levels, lipid profile, and quality of life.
RESULTS: The F-Biotic™ group exhibited significant reductions in FBS from 150.18 ± 34.78 mg/dL at baseline to 134.24 ± 39.91 mg/dL by the end of the study, compared to an increase in the placebo group from 148.61 ± 42.13 mg/dL to 157.71 ± 47.84 mg/dL. PPBS decreased by -32.97 ± 67.18 mg/dL in the F-Biotic™ group versus an increase of 21.00 ± 36.59 mg/dL in the placebo group. GLP-1 levels increased significantly in the F-Biotic™ group, while they decreased in the placebo group. No significant changes were observed in HbA1c, fasting insulin, or HOMA-IR, and no adverse events related to the investigational product were reported.
CONCLUSION: F-Biotic™ appears to be a promising adjunctive therapy for T2DM, demonstrating significant improvements in glycemic control and quality of life without adverse events related to the investigational product. Further research with longer follow-ups and larger samples is needed to confirm these findings and evaluate long-term efficacy and safety.
METHODS: Seventy participants with T2DM, aged 25-70 years, were randomized into two groups: one receiving F-Biotic™ and the other a placebo, both administered daily for 12 weeks. Key outcomes included fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), fasting insulin, insulin resistance (HOMA-IR), GLP-1 levels, lipid profile, and quality of life.
RESULTS: The F-Biotic™ group exhibited significant reductions in FBS from 150.18 ± 34.78 mg/dL at baseline to 134.24 ± 39.91 mg/dL by the end of the study, compared to an increase in the placebo group from 148.61 ± 42.13 mg/dL to 157.71 ± 47.84 mg/dL. PPBS decreased by -32.97 ± 67.18 mg/dL in the F-Biotic™ group versus an increase of 21.00 ± 36.59 mg/dL in the placebo group. GLP-1 levels increased significantly in the F-Biotic™ group, while they decreased in the placebo group. No significant changes were observed in HbA1c, fasting insulin, or HOMA-IR, and no adverse events related to the investigational product were reported.
CONCLUSION: F-Biotic™ appears to be a promising adjunctive therapy for T2DM, demonstrating significant improvements in glycemic control and quality of life without adverse events related to the investigational product. Further research with longer follow-ups and larger samples is needed to confirm these findings and evaluate long-term efficacy and safety.