Introduction: T63 has been shown to improve fasting blood glucose (FG) in individuals with prediabetes or early type 2 diabetes. However, the mechanisms underlying these effects are still unknown. We sought to assess the effects of T63 on fasting and postprandial (PP) metabolic parameters as well as on the gut microbiota.
Methods: In this 8-wk, single arm, open label, clinical trial (NCT05369585), a daily dose of 5g of T63 was given by capsules. Eligible participants had a BMI ≥27 and <40kg/m2, and either triglycerides (TG) ≥1.35mmol/L, or FG ≥5.6 and ≤6.9mmol/L, or HbA1c ≥5.6 and ≤6.4%. Blood was sampled fasting and during a 6-hour test meal for analysis of glucose homeostasis, lipids, hs-CRP, fibrinogen and incretins. Assessments were made before and after an acute intake as well as after 8 wk of supplementation. The fecal microbiota was analysed by metagenomic sequencing and the Simpson’s reciprocal index used for determination of microbial diversity.
Results: A total of 19 participants were enrolled and supplemented, (mean±SD) age 55.4±11.3 yrs, BMI 31.3±4.1kg/m2, FG 5.5±0.4mmol/L, HbA1c 5.5±0.2%, TG 1.6±0.5mmol/L, hs-CRP 3.3±2.3mg/L. Following the first acute T63 intake, PP reductions in max glucose level (p=0.03), and GIP area under the curve (AUC, p=0.01) were observed. After 8 wk of T63, significant decreases in HbA1c (to 5.3±0.3%, p=0.005), hs-CRP (to 2.5±1.8mg/L, p=0.01), fibrinogen (p=0.04) and plasma lipids (TG, total-C, non-HDL-C, LDL-C and total-C/HDL-C ratio (p<0.05 for all)) were observed, while PYY increased (p=0.02). The PP pattern at wk 8 was characterized by reductions in the AUC of both glucose (p=0.04) and insulin (p=0.009). Gut microbiota α-diversity was increased by T63 at wk 8 (p=0.003).
Conclusion: These results provide novel insights on the effects of T63 on fasting and PP glucose metabolism, inflammation and lipids, in conjunction with an increased gut microbiota diversity.
A. Bouchard-Mercier: Employee; Valbiotis. Y.F. Otero: Employee; Valbiotis. V. Chavanelle: Employee; Valbiotis. J. Marois: None. G. Pilon: None. T. Varin: None. P.L. Mitchell: None. O. Johansen: Employee; Nestlé Health Science. M. Bargetto: Employee; Valbiotis. V. Sapone: None. F. Le Joubioux: Employee; Valbiotis. M. Cazaubiel: Employee; Valbiotis. J. Bard: Consultant; Valbiotis. Stock/Shareholder; Valbiotis. S. Peltier: Stock/Shareholder; Valbiotis. Board Member; Valbiotis. P. Couture: None. M. Vohl: None. P. Sirvent: Board Member; Valbiotis. A. Marette: Advisory Panel; Valbiotis. Research Support; Acasti Pharma, Inc. Advisory Panel; Plexus, Amancia.
