Metabolic Shifting Probiotic in Type 2 Diabetes Mellitus Management: Randomized Clinical Trial
Author(s): Gissel García, Josanne Soto, Lays Rodríguez, Maricela Nuez, Noraika Domínguez, Emilio F. Buchaca, Duniesky Martínez, Rolando J Gómez, Yohanka Ávila, Martha R. Carlin, Raúl J. Cano
Objective: The objective of this study is to assess the efficacy of BiotiQuest™ Sugar Shift, a probiotic formulated to transform monosaccharides and rehabilitate human gut microbiota, in stabilize HbA1c and blood glucose, improve insulin resistance, and reduce inflammation.
Methods: A double-blind, placebo-controlled study was carried out over 12 weeks with 64 Cubans, aged 30 to 65 with Type 2 Diabetes Mellitus diagnosed, 18 of whom being treated with insulin. Participants were randomly assigned to take either two capsules of the probiotic supplement or of placebo. Clinical measures were evaluated at 28-day intervals, included fasting and post-prandial glucose, HbA1c, lipid panel, insulin, creatinine, and serum lipopolysaccharide levels were assessed.
Results: The treated group demonstrated a stabilization in their fasting blood glucose and postprandial glucose levels in treated group respect to the Placebo cohort. The HbA1c levels did not show significant changes in the treated group. The insulin levels decreased significantly in the treated group by day 84 compared to day 1 and to day 84 of the Placebo cohort (p=0.024 and p=0.015, respectively). Serum LPS levels also decreased significantly in the treated group (p=0.001).
Conclusions: BiotiQuest™ Sugar Shift is suitable as adjunct therapy for the control of T2D. However, the 12-week trial period was not sufficient to detect significant reductions in all clinical parameters measured and a longer study is recommended.