758-P: Medical Food (MF) with Butyrate Producing (BP)+Mucin Regulating (MR) Microbes Improves Glucose Control (GC) in T2D

• Published in: Diabetes (New York, N.Y.) Vol. 68; no. Supplement_1
• Main Authors: KOLTERMAN, ORVILLE G., PERRAUDEAU, FANNY, IYER, MOHAN S., EID, JOHN S., BULLARD, JAMES, SCHICKLBERGER, MARCUS F., CHENG, ANDREW, JUSTICE, NICHOLAS, MCMURDIE, PAUL, STONEBURNER, BRENDON, GINES, JESSICA, TYAGI, SURABHI, CUTCLIFFE, COLLEEN
• Format: Journal Article
• Language: English
• Published: 01.06.2019
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db19-758-P

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. In conclusion, 1) Interventions directed at increasing BP+MR may be of benefit in T2D. 2) MF-2 appears to be a safe and effective non-pharmacologic intervention for T2D which merits further investigation.