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

The 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).

[1]  B. Duncan,et al.  IDF diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045 , 2021, Diabetes Research and Clinical Practice.

[2]  M. Giera,et al.  Effects of a novel polyphenol-rich plant extract on body composition, inflammation, insulin sensitivity, and glucose homeostasis in obese mice , 2021, International Journal of Obesity.

[3]  F. Dutheil,et al.  Effects of Totum-63 on glucose homeostasis and post-prandial glycemia: a translational study. , 2021, American Journal of Physiology. Endocrinology and Metabolism.

[4]  V. Pialoux,et al.  The TOTUM-63 Supplement and High-Intensity Interval Training Combination Limits Weight Gain, Improves Glycemic Control, and Influences the Composition of Gut Mucosa-Associated Bacteria in Rats on a High Fat Diet , 2021, Nutrients.

[5]  Y. Xin,et al.  Role of the gut microbiota in type 2 diabetes and related diseases. , 2021, Metabolism: clinical and experimental.

[6]  Jiu‐liang Zhang,et al.  Targets and mechanisms of dietary anthocyanins to combat hyperglycemia and hyperuricemia: a comprehensive review , 2020, Critical reviews in food science and nutrition.

[7]  U. Suttisansanee,et al.  Investigation of Anthocyanidins and Anthocyanins for Targeting α-Glucosidase in Diabetes Mellitus , 2020, Preventive nutrition and food science.

[8]  Hélder Oliveira,et al.  Anthocyanins as Antidiabetic Agents—In Vitro and In Silico Approaches of Preventive and Therapeutic Effects , 2020, Molecules.

[9]  C. Moliner,et al.  The role of anthocyanins as antidiabetic agents: from molecular mechanisms to in vivo and human studies , 2020, Journal of Physiology and Biochemistry.

[10]  A. Ndhlala,et al.  The Potential Therapeutic Value of Medicinal Plants in the Management of Metabolic Disorders , 2020, Molecules.

[11]  S. Dagogo-Jack,et al.  Regression from prediabetes to normal glucose regulation: State of the science , 2020, Experimental biology and medicine.

[12]  F. Rutters,et al.  Risk and management of pre-diabetes , 2019, European journal of preventive cardiology.

[13]  N. Cech,et al.  Synergy and antagonism in natural product extracts: when 1 + 1 does not equal 2. , 2019, Natural product reports.

[14]  Yunzhao Tang,et al.  Apigenin prevents metabolic syndrome in high-fructose diet-fed mice by Keap1-Nrf2 pathway. , 2018, Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie.

[15]  D. Grobbee,et al.  Combined use of polypill components in patients with type 2 diabetes mellitus , 2018, European journal of preventive cardiology.

[16]  R. Silvestri,et al.  Oleuropein, a component of extra virgin olive oil, lowers postprandial glycaemia in healthy subjects , 2018, British journal of clinical pharmacology.

[17]  E. Levy,et al.  A polyphenol-rich cranberry extract reverses insulin resistance and hepatic steatosis independently of body weight loss , 2017, Molecular metabolism.

[18]  S. Harding,et al.  The Effectiveness of Lifestyle Adaptation for the Prevention of Prediabetes in Adults: A Systematic Review , 2017, Journal of diabetes research.

[19]  G. Hotamışlıgil Inflammation, metaflammation and immunometabolic disorders , 2017, Nature.

[20]  E. Heidarian,et al.  Medicinal Plants with Multiple Effects on Cardiovascular Diseases: A Systematic Review. , 2017, Current pharmaceutical design.

[21]  M. Campbell,et al.  CONSORT 2010 statement: extension to randomised pilot and feasibility trials , 2016, British Medical Journal.

[22]  S. Hopewell,et al.  CONSORT 2010 statement: extension to randomised pilot and feasibility trials. , 2016, Pilot and feasibility studies.

[23]  Myung‐Sook Choi,et al.  Apigenin Ameliorates Dyslipidemia, Hepatic Steatosis and Insulin Resistance by Modulating Metabolic and Transcriptional Profiles in the Liver of High-Fat Diet-Induced Obese Mice , 2016, Nutrients.

[24]  Shiping Ma,et al.  Apigenin and naringenin regulate glucose and lipid metabolism, and ameliorate vascular dysfunction in type 2 diabetic rats. , 2016, European journal of pharmacology.

[25]  J. Dumville,et al.  The use of unequal randomisation in clinical trials--An update. , 2015, Contemporary clinical trials.

[26]  E. Levy,et al.  Gut Microbiota Dysbiosis in Obesity-Linked Metabolic Diseases and Prebiotic Potential of Polyphenol-Rich Extracts , 2015, Current Obesity Reports.

[27]  Z. Sarem,et al.  The Flavones Apigenin and Luteolin Induce FOXO1 Translocation but Inhibit Gluconeogenic and Lipogenic Gene Expression in Human Cells , 2014, PloS one.

[28]  E. Levy,et al.  A polyphenol-rich cranberry extract protects from diet-induced obesity, insulin resistance and intestinal inflammation in association with increased Akkermansia spp. population in the gut microbiota of mice , 2014, Gut.

[29]  Daniël Lakens,et al.  Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs , 2013, Front. Psychol..

[30]  Wolfgang Rathmann,et al.  Prediabetes: a high-risk state for diabetes development , 2012, The Lancet.

[31]  E. Thom The Effect of Chlorogenic Acid Enriched Coffee on Glucose Absorption in Healthy Volunteers and Its Effect on Body Mass When Used Long-term in Overweight and Obese People , 2007, The Journal of international medical research.

[32]  M. Clifford,et al.  Coffee acutely modifies gastrointestinal hormone secretion and glucose tolerance in humans: glycemic effects of chlorogenic acid and caffeine. , 2003, The American journal of clinical nutrition.

[33]  S. Fowler,et al.  Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. , 2002, The New England journal of medicine.

[34]  E. Martínez-Abundis,et al.  Effect of Chlorogenic Acid Administration on Glycemic Control, Insulin Secretion, and Insulin Sensitivity in Patients with Impaired Glucose Tolerance. , 2017, Journal of medicinal food.

[35]  Zaiqi Zhang,et al.  Synergy effects of herb extracts: pharmacokinetics and pharmacodynamic basis. , 2014, Fitoterapia.