Over 1 billion people worldwide suffer prediabetes, which is defined by increased fasting blood glucose (FBG), glucose intolerance and/or higher A1c hemoglobin. Prediabetes is considered a risk factor for type 2 diabetes (T2D). We have developed Totum-63, a plant-based product designed to reduce T2D risk factors. In a phase I/II clinical trial, Totum-63 had shown its safety, good tolerance and beneficial effects on post-prandial glucose control in healthy subjects. The aim of this multicentre, randomised and double-blind placebo-controlled phase IIA trial was to show the efficiency of Totum-63 in reducing FBG (primary endpoint) in 51 volunteers with prediabetes (defined by FBG ≥ 1.1 g/l and 2h OGTT glycemia ≥ 1.1 g/l). Secondary endpoints included blood glucose change following an oral glucose tolerance test (OGTT) and anthropometric parameters. Totum-63 (5g/day) or placebo was given to the participants for 6 months.

At the end of the supplementation period, FBG was reduced in Totum-63 group compared to placebo group (difference from baseline: -0.04 ± 0.02 vs. +0.09 ± 0.04 g/l, p<0.05). Similarly, 2-hour OGTT glycemia was improved in Totum-63 group, vs. placebo (difference from pre-protocol value: -0.02 ± 0.07 vs. +0.32 ± 0.17 g/l, p<0.05). Moreover, Totum-63 had a significant lowering effect on body weight (-0.07 ± 0.42 vs. +1.83 ± 0.57 Kg; p<0.05) and waist circumference (-1.67 ± 0.73 vs. +2.81 ± 0.65 cm; p<0.001).

To conclude, the primary endpoint of this clinical trial was reached, Totum-63 contributed to lower FBG in individuals with prediabetes. Moreover, the response to an OGTT was improved, as well as body weight and waist circumference, thus making Totum-63 a promising candidate for T2D risk prevention.

Disclosure

S. Peltier: Board Member; Self; Valbiotis. V. Chavanelle: Employee; Self; Valbiotis. Y.F. Otero: Employee; Self; Valbiotis. M. Bargetto: Employee; Self; Valbiotis. M. Cazaubiel: Board Member; Self; Valbiotis. B. Pereira: None. P. Sirvent: Board Member; Self; Valbiotis. J. Bard: Consultant; Self; Biofortis, Valbiotis. Stock/Shareholder; Self; Valbiotis.

© 2020 by the American Diabetes Association
2020
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