This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of consumption.

开始日期2020-07-08

申办/合作机构

Valbiotis SA

100 项与 TOTUM-63 相关的临床结果

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100 项与 TOTUM-63 相关的转化医学

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100 项与 TOTUM-63 相关的专利（医药）

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项与 TOTUM-63 相关的文献（医药）

2022-12-01·Diabetes, Obesity and Metabolism

TOTUM‐63, a plant‐based polyphenol‐rich extract, improves glycaemic control in subjects with prediabetes or early stage newly‐diagnosed type 2 diabetes in a randomized, double‐blind, placebo‐controlled trial

Article

作者: Guigas, Bruno ; Pereira, Bruno ; Boisseau, Nathalie ; Bard, Jean‐Marie ; Marette, André ; Hadjadj, Samy ; Bargetto, Maxime ; Peltier, Sebastien L. ; Chavanelle, Vivien ; Otero, Yolanda F. ; Le Joubioux, Florian ; Sirvent, Pascal ; Maugard, Thierry ; Cazaubiel, Murielle

AbstractAimThe plant‐based polyphenol‐rich extract TOTUM‐63 improves glucose homeostasis in various preclinical models of obesity and type 2 diabetes (T2D). A pilot exploratory study showed that TOTUM‐63 has good safety and tolerability profiles, and beneficial effects on postprandial glucose control in healthy individuals with overweight. The aim of this study was to assess the effects of TOTUM‐63 on glycaemic control in individuals with prediabetes or early stage newly‐diagnosed T2D (which does not require pharmacological treatment).Materials and MethodsThis study was a multicentre, randomized, double‐blind, placebo‐controlled trial. Individuals with prediabetes or early stage newly‐diagnosed T2D and with overweight/abdominal obesity received TOTUM‐63 (5 g/day) or placebo for 6 months. The primary outcome was the change in fasting blood glucose.ResultsFifty‐one participants (age: 57.1 ± 10 years; body mass index: 31.3 ± 5.7 kg.m2; 35 women and 16 men) completed the study (n = 38 TOTUM‐63, n = 13 placebo). After 6 months, blood glucose concentration after fasting and after the 2‐h oral glucose tolerance test was reduced in the TOTUM‐63‐treated group compared with the placebo group (placebo‐corrected difference between baseline and month 6: −0.71 mmol/L, p < .05, and −1.93 mmol/L, p < .05, respectively). TOTUM‐63 was safe and well tolerated and significantly reduced body weight gain (−1.9 kg; p < .05), waist circumference (−4.5 cm; p < .001), circulating triglycerides (−0.54 mmol/L; p < .01) and low‐density lipoprotein‐cholesterol (−0.38 mmol/L; p < .05) compared with placebo.ConclusionsTOTUM‐63 lowered fasting blood glucose in participants with impaired fasting glycaemia and glucose intolerance. Moreover, TOTUM‐63 showed a good safety and tolerability profile and improved several metabolic syndrome features. Therefore, TOTUM‐63 is a promising candidate for T2D prevention.

2022-07-01·Nutrition, Metabolism and Cardiovascular Diseases

Impact of TOTUM-63, a fibre and polyphenol rich plant-based composition, on gut and pancreatic hormone secretion in diet-induced obese mice

Article

作者: Pinteur, Claudie ; Maugard, Thierry ; Le Joubioux, Florian ; Chavanelle, Vivien ; Morio, Béatrice ; Sirvent, Pascal ; Otero, Yolanda F ; Chanon, Stéphanie ; Vial, Guillaume ; Loizon, Emmanuelle ; Peltier, Sébastien L

BACKGROUND AND AIMSTOTUM-63, a fibre and polyphenol rich plant-based composition, has been demonstrated to significantly improve body weight and glucose homeostasis in animal models of obesity. Our study aimed at exploring whether the mechanisms include modulation of gut (glucose-dependent insulinotropic peptide (GIP), glucagon-like petide-1 (GLP-1), cholecystokinin (CCK), peptide YY (PYY)) and pancreatic (insulin, glucagon) hormones, all important regulators of glucose control, appetite and body weight.METHODS AND RESULTSMale C57BL/6JRJ mice were assigned to either standard chow (CON), high fat diet (HF, 60% energy from fat) or HF-TOTUM-63 (HF diet 60% supplemented with TOTUM-63 2.7%) for 10 weeks. In vivo glucose homeostasis (oral glucose tolerance test (OGTT), intraperitoneal pyruvate tolerance test (ipPTT)), glucose-induced portal vein hormone concentration, gut hormone gene expression and protein content as well as enteroendocrine cell contents were assessed at the end of the dietary intervention. The present study evidenced that TOTUM-63 reduced food intake, limited weight gain and improved glucose and pyruvate tolerance of HF-fed animals. This was associated with an increase in PYY content in the colon, an altered pattern of PYY secretion between fasted and glucose-stimulated states, and with a significant improvement in the portal vein concentration of GLP-1, insulin and glucagon, but not GIP and CCK, in response to glucose stimulation.CONCLUSIONOverall, these data suggest that TOTUM-63 might have a specific impact on gut L-cells and on the expression and secretion of GLP-1 and PYY incretins, potentially contributing to the reduced food intake, body weight gain and improved glucose homeostasis.

2021-09-01·International Journal of Obesity2区 · 医学

Effects of a novel polyphenol-rich plant extract on body composition, inflammation, insulin sensitivity, and glucose homeostasis in obese mice

2区 · 医学

Article

作者: Lantier, Louise ; Otero, Yolanda ; Lambooij, Joost M ; van der Zande, Hendrik J P ; Peltier, Sébastien L ; Guigas, Bruno ; Giera, Martin ; Otto, Frank ; McGuinness, Owen P ; Zawistowska-Deniziak, Anna ; Sirvent, Pascal ; Maugard, Thierry ; Le Joubioux, Florian ; Chavanelle, Vivien

BACKGROUND/OBJECTIVESThe worldwide prevalence of obesity, metabolic syndrome and type 2 diabetes (T2D) is reaching epidemic proportions that urge the development of new management strategies. Totum-63 is a novel, plant-based polyphenol-rich active principle that has been shown to reduce body weight, fasting glycemia, glucose intolerance, and fatty liver index in obese subjects with prediabetes. Here, we investigated the effects and underlying mechanism(s) of Totum-63 on metabolic homeostasis in insulin-resistant obese mice.METHODSMale C57Bl6/J mice were fed a high-fat diet for 12 weeks followed by supplementation with Totum-63 for 4 weeks. The effects on whole-body energy and metabolic homeostasis, as well as on tissue-specific inflammation and insulin sensitivity were assessed using a variety of immunometabolic phenotyping tools.RESULTSTotum-63 decreased body weight and fat mass in obese mice, without affecting lean mass, food intake and locomotor activity, and increased fecal energy excretion and whole-body fatty acid oxidation. Totum-63 reduced fasting plasma glucose, insulin and leptin levels, and improved whole-body insulin sensitivity and peripheral glucose uptake. The expression of insulin receptor β and the insulin-induced phosphorylation of Akt/PKB were increased in liver, skeletal muscle, white adipose tissue (WAT) and brown adipose tissue (BAT). Hepatic steatosis was also decreased by Totum-63 and associated with a lower expression of genes involved in fatty acid uptake, de novo lipogenesis, inflammation, and fibrosis. Furthermore, a significant reduction in pro-inflammatory macrophages was also observed in epidydimal WAT. Finally, a potent decrease in BAT mass associated with enhanced tissue expression of thermogenic genes was found, suggesting BAT activation by Totum-63.CONCLUSIONSOur results show that Totum-63 reduces inflammation and improves insulin sensitivity and glucose homeostasis in obese mice through pleiotropic effects on various metabolic organs. Altogether, plant-derived Totum-63 might constitute a promising novel nutritional supplement for alleviating metabolic dysfunctions in obese people with or without T2D.

100 项与 TOTUM-63 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床2期	波兰	Valbiotis SA	2020-07-08
2型糖尿病	临床2期	法国	Valbiotis SA	2020-07-08
2型糖尿病	临床2期	德国	Valbiotis SA	2020-07-08
2型糖尿病	临床2期	意大利	Valbiotis SA	2020-07-08
2型糖尿病	临床2期	保加利亚	Valbiotis SA	2020-07-08
2型糖尿病	药物发现	罗马尼亚	Valbiotis SA	2020-07-08
2型糖尿病	药物发现	匈牙利	Valbiotis SA	2020-07-08

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04423302 (REVERSE-IT, ADA2024) 人工标引	N/A	2型糖尿病 \| 糖尿病前期	636	Totum-63 (T63) (T63 (5g/day, TID))	(鏇範蓋簾繭窪糧餘餘遞) = 觸窪觸艱壓齋齋憲簾衊醖鑰鬱製襯壓構鑰蓋醖 (淵繭糧膚憲網觸顧窪繭 ) 更多	积极	2024-06-21
				Totum-63 (T63) (T63 (5g/day, BID))	(鏇範蓋簾繭窪糧餘餘遞) = 遞淵鹹襯齋顧齋鹽遞鑰醖鑰鬱製襯壓構鑰蓋醖 (淵繭糧膚憲網觸顧窪繭 ) 更多
NCT04423302 (Pubmed) 人工标引	N/A	2型糖尿病 \| 糖尿病前期	51	TOTUM-63	(鏇廠觸淵衊艱齋艱遞繭) = 齋範廠鏇範獵簾齋襯觸構糧觸範獵選積蓋鹽製 (齋憲範簾觸製簾簾繭艱 ) 更多	积极	2022-07-15
				Placebo	-
Phase II (EASD2020)	临床2期	-	-	Totum-63	(襯鹹糧鑰鏇夢製製積夢) = 壓構鹽壓齋選築構蓋鬱鑰壓鬱繭觸鹹鹹製鏇觸 (夢淵壓觸醖餘鹽願膚範 ) 更多	积极	2020-09-23
ADA2020	N/A	糖尿病前期	51	Totum-63	(餘遞願窪餘夢夢壓齋鹹) = 窪獵廠齋築窪構鬱夢糧範簾鹽淵壓蓋繭糧範淵 (選製艱製選鏇齋蓋製繭 ) 更多	积极	2020-06-01
				Placebo	(餘遞願窪餘夢夢壓齋鹹) = 糧範膚觸夢範鹽鑰鬱艱範簾鹽淵壓蓋繭糧範淵 (選製艱製選鏇齋蓋製繭 ) 更多
EASD2019	N/A	脂质代谢紊乱	-	TOTUM-63	艱鹽艱積鹽襯願淵襯願(壓獵簾齋齋鏇觸鹽選鹽) = 糧艱簾繭糧範願夢簾壓壓觸壓艱願獵選鹽鏇襯 (蓋壓獵糧簾選鏇醖夢淵 )	-	2019-09-18