Studies show that BP+MR are decreased inT2D; the impact of administering specific strains has not been reported. A 12-week, double blind, placebo-controlled study of 2 MFs prepared GMP using only GRAS constituents (MF-1: BP; MF-2: BP + MR) in T2D (drug naive + metformin ± SFU, n=76), showed improved GC. See Table for demographics and key results. The primary endpoint was change from baseline (∆) in total glucose AUC0-180 min during a Boost Plus™ (720 cal) MTT. At 12 weeks, MF-2 yielded significant ∆s in both total (T) and incremental (I) glucose AUC0-180 min, (p=0.05 and 0.007 respectively). MF-1 improved only I glucose AUC0-180 min (p=0.05). Neither MF-1 or MF-2 impacted fasting glucose, T or I insulin AUC0-180 min, weight, BMI, HOMA-IR, lipids, or c-reactive protein. No safety or tolerability concerns were observed. Pre and post fecal microbial analyses are pending. Post hoc analyses revealed 2 interesting results. 1) SFU subjects across both study groups showed minimal response while subjects not using SFUs had greater ∆s in both T glucose AUC0-180 min (-24.4%) and placebo-corrected ∆ A1c (-0.7%). 2) MF-2 showed significant reductions in ALT consistent with improved liver health.
O.G. Kolterman: Advisory Panel; Spouse/Partner; Intarcia Therapeutics, Inc. Advisory Panel; Self; Zafgen, Inc. Board Member; Self; American Diabetes Association, GlySens Incorporated, Viacyte, Inc. Consultant; Self; ADOCIA, Cirius Therapeutics Inc, DiaVacs Inc, JDRF, Nanoprecisionmedical, NuSirt Biopharma, Inc., Renova Therapeutics, Sensulin, LLC. Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Corcept Therapeutics, GI Therapeutics, Xeris Pharmaceuticals, Inc. Other Relationship; Spouse/Partner; American Diabetes Association. F. Perraudeau: Employee; Self; Whole Biome. M.S. Iyer: Employee; Self; Whole Biome Inc. J.S. Eid: Board Member; Self; Whole Biome Inc. J. Bullard: Employee; Self; Whole Biome Inc. Stock/Shareholder; Self; Whole Biome Inc. M.F. Schicklberger: Employee; Self; Whole Biome Inc. A. Cheng: None. N. Justice: Employee; Self; Whole Biome. P. McMurdie: Employee; Self; Whole Biome, Inc. B. Stoneburner: None. J. Gines: Employee; Self; Whole Biome Inc. S. Tyagi: None. C. Cutcliffe: Employee; Self; Whole Biome Inc.