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| ID | Type | Description | Link |
|---|---|---|---|
| 255926 | Other Identifier | Health Canada | |
| 2021-408 | Other Identifier | CERUL |
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| Name | Class |
|---|---|
| Laval University | OTHER |
| Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | OTHER |
| Valbiotis Canada inc. | UNKNOWN |
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This clinical study aims to investigate the effects of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day, on cardiometabolic health and gut microbiota profile in overweight-obese individuals.
In 2019, over 460 million adults had diabetes worldwide. Moreover, it was estimated by the International Diabetes Federation that about 700 million adults will have type 2 diabetes (T2D) by 2045. Valbiotis is a research & development company dedicated to scientific innovation for preventing and reducing the risk of metabolic and cardiovascular disease (CVD) using specific combinations of plant-based molecules. Valbiotis developed a formula (TOTUM-63) which is composed by the association of five plant extracts.
Given the results obtained in pre-clinical studies, as well as the good tolerance and first efficacy results of TOTUM-63 in two clinical trials on human subjects, this research aims to investigate the effects of TOTUM-63 on cardiometabolic health and gut microbiota profile in overweight-obese individuals. TOTUM-63 will be tested (5g acutely and 5g/d over 8 weeks of supplementation) on energy metabolism, post-prandial nutrients metabolism and hepatic health in overweight and obese subjects. Blood and feces samples collected before, and after the supplementation will allow to perform metabolomic, transcriptomic and metagenomics analyses to further explore the potential mechanisms of action of TOTUM-63.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTUM-63 | Experimental | Experimental active are supplemented with TOTUM-63, taken 3 times per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOTUM-63 | Dietary Supplement | 5-g per day dose of TOTUM-63 supplement, a mix of 5 plant extracts. Daily dose for 8 weeks followed by a 4 weeks follow-up period without supplementation. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of blood pressure | Systolic blood pressure, diastolic blood pressure (in mmHg) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of heart rate | Heart rate (in BPM) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of weight | Weight (in kg) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of waist circumference | Waist circumference (in cm) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of body mass index | Body mass index (in kg/m2) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of fasting glycemia | Fasting glycemia (in mmol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of insulin secretion | Fasting insulinemia and C-peptide (in pmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of Safety parameters (hepatic enzymes) | Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT) (in U/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of Safety parameters (AST/ALT ratio) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André Marette, PhD | Laval University | Principal Investigator |
| Patrick Couture, MD FRCP PhD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutrition and Funtional Foods (INAF) - Laval University | Québec | G1V 0A6 | Canada |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000728347 | TOTUM-63 |
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Open-label, single center, single arm
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| Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of HbA1c | Fasting HbA1c (in %) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of satiety hormones | Peptide tyrosine tyrosine (PYY), cholecystokinin (in pg/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of adipokines | Adiponectin, leptin, plasminogen activator inhibitor 1 (in ng/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of inflammatory response (fibrinogen) | Fibrinogen (in ng/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of inflammatory response (IL6, TNFa) | Interleukin 6, tumour necrosis factor alpha (in pg/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of inflammatory response (hs-CRP) | High-sensitivity C-reactive protein (in mg/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of incretin response | Glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 (in pg/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of blood lipid profile (lipid profile) | Triglycerides, total cholesterol, HDL-C, non-HDL-C, LDL-C, free-fatty-acids (in mmol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of blood lipid profile (oxidized-LDL) | Oxidized-LDL (in ng/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of blood lipid profile (ketones) | Ketones (in umol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of fecal and plasma bile acid profiles | Primary and secondary bile acids profiles (fecal and plasma) (in uM) | Baseline and V3 (8 weeks of intervention) |
| Evolution of metagenomic parameters (whole metagenome shotgun sequencing) | Whole metagenome shotgun sequencing | Baseline and V3 (8 weeks of intervention) |
| Evolution of metagenomic parameters (microbiota diversity) | Microbiota diversity measurements (Shannon index) | Baseline and V3 (8 weeks of intervention) |
| Evolution of metagenomic parameters (microbiota richness) | Microbiota richness measurements (Simpson index) | Baseline and V3 (8 weeks of intervention) |
| Evolution of liver MRI | Liver fat content | Baseline and V3 (8 weeks of intervention) |
| Evolution of FIB-4 index | FIB-4 index (FIB-4 index < 1.45 in the context of steatosis allows the exclusion of a clinically significant fibrosis) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of BARD score | BARD score (from 0 to 4, with a score of 4 resulting in a higher risk of advanced fibrosis) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of NAFLD fibrosis score | NAFLD fibrosis score (< -1.455 low fibrosis probability; -1.455 to 0.676 intermediate score; > 0.676 high probability of fibrosis) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution in kinetics of glucose metabolism | Evaluation of glucose concentrations during a 6-hours mixed-meal tolerance test (in mmol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution in kinetics of insulin secretion | Evaluation of blood insulin and C-peptide during a 6-hours mixed-meal tolerance test (in pmol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution in kinetics of blood lipid profile | Evaluation of triglycerides, total cholesterol, HDL-C, non-HDL-C and LDL-C during a 6-hours mixed-meal tolerance test (in mmol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of kinetics of incretin parameters | Evaluation of glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 during a 2-hours mixed-meal tolerance test (in pg/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of inflammatory parameters (fibrinogen) | Evaluation of fibrinogen before and after a 6-hours mixed-meal tolerance test (in ng/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of inflammatory parameters (IL6, TNFA) | Evaluation of interleukin 6, tumour necrosis factor alpha before and after a 6-hours mixed-meal tolerance test (in pg/ml) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of inflammatory parameters (hs-CRP) | Evaluation high-sensitivity C-reactive protein before and after a 6-hours mixed-meal tolerance test (in mg/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of energy metabolism (respiratory quotient) | Evaluation of respiratory quotient before and after a 6-hours mixed-meal tolerance test (in carbon dioxide (CO2) eliminated / dioxygen (O2) consumed) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of energy metabolism (resting metabolic rate) | Evaluation of resting metabolic rate before and after a 6-hours mixed-meal tolerance test (in kcal/day) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of energy metabolism (energy expenditure) | Evaluation of energy expenditure before and after a 6-hours mixed-meal tolerance test (in kcal/kg/h) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
AST/ALT ratio |
| Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of Safety parameters (albumin) | Albumin (in g/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of Safety parameters (creatinine) | Creatinine (in umol/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of complete blood count (red and white blood cells, platelet) | Red blood cells, white blood cells, platelet (in cells/mm3) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of complete blood count (hemoglobin) | Hemoglobin (in g/L) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of complete blood count (hematocrit) | Hematocrit (in %) | Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up) |
| Evolution of transcriptomics | RNA sequencing | Baseline and V3 (8 weeks of intervention) |
| Evolution of metabolomics (amino acids, fatty acids and acylcarnitine species) | Evolution of amino acids, fatty acids and acylcarnitine species (in uM) | Baseline and V3 (8 weeks of intervention) |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |