73-OR: The Plant-Based Substance Totum-63 (T63) Reduces Fasting Plasma Glucose and HbA1c in People with Prediabetes or Type 2 Diabetes (T2D)—A 24-Week Multicenter Randomized Controlled Trial (REVERSE-IT)
Authors: OTERO YOLANDA F. , SIRVENT PASCAL , ERIK JOHANSEN ODD , CHAVANELLE VIVIEN , BOUCHARD-MERCIER ANNIE , SAPONE VERONIQUE , BARGETTO MAXIME , LE JOUBIOUX FLORIAN , PEREIRA BRUNO , CAZAUBIEL MURIELLE , BOISSEAU NATHALIE , MAUGARD THIERRY , GUIGAS BRUNO , PELTIER SEBASTIEN , BARD JEAN-MARIE , WOERLE HANS-JUERGEN , HADJADJ SAMY , MARETTE ANDRE 
Published: June 2024

Introduction: The impact of natural-based products for glycemic management in people with prediabetes or early T2D is debated. We conducted a multicenter, multi-country prospective study (REVERSE-IT) for 24 weeks in this population where T63, a plant-based polyphenol-rich product provided in capsules, was compared with placebo (PBO) (NCT04423302).

Methods: A total of 636 volunteers (59% women, age 56.5±9.1 yrs, BMI 31.7±4.8 kg/m2, HbA1c 6.1±0.9%, fasting plasma glucose [FPG] 122±22 mg/dL) were recruited from 52 sites across 7 European countries in 2020-2023, of whom 78.8% had prediabetes (HbA1c 5.9±0.5%, FPG 116±14 mg/dL) and 21.2% early T2D (HbA1c 6.9±1.2%, FPG 146±30 mg/dL). Volunteers were randomly assigned (1:1:1) to receive T63 (5g/day, TID), PBO (TID) or T63 (5g/day, BID) where TID administration was double-blind and BID open label. General lifestyle advice was also provided. The primary endpoint was change in FPG and secondary outcomes included effects on HbA1c, blood lipids, and body weight.

Results: FPG significantly decreased with T63 vs PBO (-5.8 mg/dL TID analysis p&lt;0.05; -8.1mg/dL BID analysis p&lt;0.0001). T63 also reduced HbA1c (-0.11% in TID analysis, p=0.06, -0.18% in BID analysis, p&lt;0.01). T63 exerted additional modest metabolic benefits on lipid parameters and body weight (-0.7kg in TID analysis, p&lt;0.05, -0.8kg in BID analysis, p&lt;0.05). A more pronounced impact on glycemic parameters was observed with increased baseline (BL) levels, evidenced by the linear regression equation for projected HbA1c change with both TID (-0.35 x Hba1cBL + 2.04 [p&lt;0.01]) and BID dosing (-0.59 x Hba1cBL + 3.46 [p&lt;0.001)). T63 was well tolerated, and compliance &gt; 96% across groups.

Conclusion: This study supports the beneficial impact of 5g/day of T63 to promote healthy glucose levels and to induce significant effects on glucometabolic parameters in people with prediabetes or early T2D.

Disclosure

Y.F. Otero: Employee; Valbiotis. P. Sirvent: Board Member; Valbiotis. O. Johansen: Employee; Nestlé Health Science. V. Chavanelle: Employee; Valbiotis. A. Bouchard-Mercier: Employee; Valbiotis. V. Sapone: None. M. Bargetto: Employee; Valbiotis. F. Le Joubioux: Employee; Valbiotis. B. Pereira: None. M. Cazaubiel: Employee; Valbiotis. N. Boisseau: Consultant; Valbiotis. Stock/Shareholder; Valbiotis. T. Maugard: None. B. Guigas: Research Support; Valbiotis. Advisory Panel; Valbiotis. S. Peltier: Stock/Shareholder; Valbiotis. Board Member; Valbiotis. J. Bard: Consultant; Valbiotis. Stock/Shareholder; Valbiotis. H. Woerle: Employee; Nestlé Health Science. S. Hadjadj: Consultant; AstraZeneca. Research Support; Asten Santé, Air Liquide. Consultant; Bayer Inc., Boehringer-Ingelheim, Eli Lilly and Company. Research Support; LVL, Nestlé Health Science. Consultant; Novo Nordisk. Board Member; Valbiotis. Consultant; Sanofi. Research Support; Vitalaire. A. Marette: Advisory Panel; Valbiotis. Research Support; Acasti Pharma, Inc. Advisory Panel; Plexus, Amancia.