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Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk

Primary Purpose

Prediabetic State, Dysglycemia, Overweight and Obesity

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

TOTUM-63

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Dysglycemia, Prediabetes, Diabetes risk, Cardio-metabolic risk, Diet supplement, Plant extracts, Polyphenols, Microbiota, Magnetic Resonance Imaging

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Main Inclusion Criteria:

Body mass index (BMI) between ≥ 27 and < 40 kg/m2 kg/m²;
Waist circumference > 94 cm for men and > 80 cm for women;
Weight stable within ± 5% in the last three months;
Fasting plasma TG ≥ 1.35 OR fasting glycemia ≥ 5.6 and ≤ 6.9 mmol/L OR HbA1c ≥ 5.6 and ≤ 6.4 %

Main Exclusion Criteria:

Any metabolic disorder requiring pharmacological treatment and susceptible to affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator;
Taking medication which may affect the study outcomes (or a medication modification less than 3 months prior to the study);
To have taken regularly natural health products or enriched foods susceptible to modify the parameters followed by the investigator within the 3 months prior to the study;
With a known or suspected food allergy, intolerance or hypersensitivity to any of the study products' ingredient as well as the non-medicinal ingredients of the product;
Consuming more than 4 drinks of alcohol per week;
Having a lifestyle deemed incompatible with the study according to the investigator including high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded);
Pregnant or lactating women or intending to become pregnant within the timeframe of the study;
Fasting blood triglycerides (TG) > 2.5 mmol/L;
Fasting blood LDL-C > 4.9mmol/L or non-HDL-C > 5.7 mmol/L;
Blood AST ≥ 45 U/L for men; and blood AST ≥ 35 U/L for women;
Blood ALT ≥ 60 U/L for men; and blood ALT ≥ 50 U/L for women;
Blood GGT ≥ 75 U/L for men; and blood GGT ≥ 50 U/L for women;
Blood creatinine concentration > 125 μmol/L AND Estimated Glomerular Filtration Rate (eGFR) (calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) < 60 mL/min/1.73m²;
Complete blood count (CBC) with hemoglobin < 120 g/L or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator.

Sites / Locations

Institute of Nutrition and Funtional Foods (INAF) - Laval UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOTUM-63

Arm Description

Experimental active are supplemented with TOTUM-63, taken 3 times per day.

Outcomes

Primary Outcome Measures

Evolution of blood pressure

Systolic blood pressure, diastolic blood pressure (in mmHg)

Evolution of heart rate

Heart rate (in BPM)

Evolution of weight

Weight (in kg)

Evolution of waist circumference

Waist circumference (in cm)

Evolution of body mass index

Body mass index (in kg/m2)

Evolution of fasting glycemia

Fasting glycemia (in mmol/L)

Evolution of insulin secretion

Fasting insulinemia and C-peptide (in pmol/L)

Evolution of HbA1c

Fasting HbA1c (in %)

Evolution of satiety hormones

Peptide tyrosine tyrosine (PYY), cholecystokinin (in pg/ml)

Evolution of adipokines

Adiponectin, leptin, plasminogen activator inhibitor 1 (in ng/ml)

Evolution of inflammatory response (fibrinogen)

Fibrinogen (in ng/ml)

Evolution of inflammatory response (IL6, TNFa)

Interleukin 6, tumour necrosis factor alpha (in pg/ml)

Evolution of inflammatory response (hs-CRP)

High-sensitivity C-reactive protein (in mg/L)

Evolution of incretin response

Glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 (in pg/ml)

Evolution of blood lipid profile (lipid profile)

Triglycerides, total cholesterol, HDL-C, non-HDL-C, LDL-C, free-fatty-acids (in mmol/L)

Evolution of blood lipid profile (oxidized-LDL)

Oxidized-LDL (in ng/ml)

Evolution of blood lipid profile (ketones)

Ketones (in umol/L)

Evolution of fecal and plasma bile acid profiles

Primary and secondary bile acids profiles (fecal and plasma) (in uM)

Evolution of metagenomic parameters (whole metagenome shotgun sequencing)

Whole metagenome shotgun sequencing

Evolution of metagenomic parameters (microbiota diversity)

Microbiota diversity measurements (Shannon index)

Evolution of metagenomic parameters (microbiota richness)

Microbiota richness measurements (Simpson index)

Evolution of liver MRI

Liver fat content

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)

Evolution of BARD score

BARD score (from 0 to 4, with a score of 4 resulting in a higher risk of advanced fibrosis)

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)

Evolution in kinetics of glucose metabolism

Evaluation of glucose concentrations during a 6-hours mixed-meal tolerance test (in mmol/L)

Evolution in kinetics of insulin secretion

Evaluation of blood insulin and C-peptide during a 6-hours mixed-meal tolerance test (in pmol/L)

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)

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)

Evolution of inflammatory parameters (fibrinogen)

Evaluation of fibrinogen before and after a 6-hours mixed-meal tolerance test (in ng/ml)

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)

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)

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)

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)

Evolution of energy metabolism (energy expenditure)

Evaluation of energy expenditure before and after a 6-hours mixed-meal tolerance test (in kcal/kg/h)

Secondary Outcome Measures

Evolution of Safety parameters (hepatic enzymes)

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT) (in U/L)

Evolution of Safety parameters (AST/ALT ratio)

AST/ALT ratio

Evolution of Safety parameters (albumin)

Albumin (in g/L)

Evolution of Safety parameters (creatinine)

Creatinine (in umol/L)

Evolution of complete blood count (red and white blood cells, platelet)

Red blood cells, white blood cells, platelet (in cells/mm3)

Evolution of complete blood count (hemoglobin)

Hemoglobin (in g/L)

Evolution of complete blood count (hematocrit)

Hematocrit (in %)

Evolution of transcriptomics

RNA sequencing

Evolution of metabolomics (amino acids, fatty acids and acylcarnitine species)

Evolution of amino acids, fatty acids and acylcarnitine species (in uM)

Full Information

NCT ID

NCT05369585

First Posted

April 5, 2022

Last Updated

May 5, 2022

Sponsor

Valbiotis

Collaborators

Laval University, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Valbiotis Canada inc.

1. Study Identification

Unique Protocol Identification Number

NCT05369585

Brief Title

Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk

Official Title

An Open-label, Single Arm, Clinical Trial to Explore the Consumption Effects of TOTUM-63 on Metabolic Signatures, Microbiome, Energy Metabolism and Post-prandial Nutrient Processing in Individuals at Increased Cardio-metabolic Risk

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2022 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Valbiotis

Collaborators

Laval University, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Valbiotis Canada inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetic State, Dysglycemia, Overweight and Obesity

Keywords

Dysglycemia, Prediabetes, Diabetes risk, Cardio-metabolic risk, Diet supplement, Plant extracts, Polyphenols, Microbiota, Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open-label, single center, single arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TOTUM-63

Arm Type

Experimental

Arm Description

Experimental active are supplemented with TOTUM-63, taken 3 times per day.

Intervention Type

Dietary Supplement

Intervention Name(s)

TOTUM-63

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evolution of blood pressure

Description

Systolic blood pressure, diastolic blood pressure (in mmHg)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of heart rate

Description

Heart rate (in BPM)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of weight

Description

Weight (in kg)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of waist circumference

Description

Waist circumference (in cm)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of body mass index

Description

Body mass index (in kg/m2)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of fasting glycemia

Description

Fasting glycemia (in mmol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of insulin secretion

Description

Fasting insulinemia and C-peptide (in pmol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of HbA1c

Description

Fasting HbA1c (in %)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of satiety hormones

Description

Peptide tyrosine tyrosine (PYY), cholecystokinin (in pg/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of adipokines

Description

Adiponectin, leptin, plasminogen activator inhibitor 1 (in ng/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of inflammatory response (fibrinogen)

Description

Fibrinogen (in ng/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of inflammatory response (IL6, TNFa)

Description

Interleukin 6, tumour necrosis factor alpha (in pg/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of inflammatory response (hs-CRP)

Description

High-sensitivity C-reactive protein (in mg/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of incretin response

Description

Glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 (in pg/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of blood lipid profile (lipid profile)

Description

Triglycerides, total cholesterol, HDL-C, non-HDL-C, LDL-C, free-fatty-acids (in mmol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of blood lipid profile (oxidized-LDL)

Description

Oxidized-LDL (in ng/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of blood lipid profile (ketones)

Description

Ketones (in umol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of fecal and plasma bile acid profiles

Description

Primary and secondary bile acids profiles (fecal and plasma) (in uM)

Time Frame

Baseline and V3 (8 weeks of intervention)

Title

Evolution of metagenomic parameters (whole metagenome shotgun sequencing)

Description

Whole metagenome shotgun sequencing

Time Frame

Baseline and V3 (8 weeks of intervention)

Title

Evolution of metagenomic parameters (microbiota diversity)

Description

Microbiota diversity measurements (Shannon index)

Time Frame

Baseline and V3 (8 weeks of intervention)

Title

Evolution of metagenomic parameters (microbiota richness)

Description

Microbiota richness measurements (Simpson index)

Time Frame

Baseline and V3 (8 weeks of intervention)

Title

Evolution of liver MRI

Description

Liver fat content

Time Frame

Baseline and V3 (8 weeks of intervention)

Title

Evolution of FIB-4 index

Description

FIB-4 index (FIB-4 index < 1.45 in the context of steatosis allows the exclusion of a clinically significant fibrosis)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of BARD score

Description

BARD score (from 0 to 4, with a score of 4 resulting in a higher risk of advanced fibrosis)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of NAFLD fibrosis score

Description

NAFLD fibrosis score (< -1.455 low fibrosis probability; -1.455 to 0.676 intermediate score; > 0.676 high probability of fibrosis)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution in kinetics of glucose metabolism

Description

Evaluation of glucose concentrations during a 6-hours mixed-meal tolerance test (in mmol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution in kinetics of insulin secretion

Description

Evaluation of blood insulin and C-peptide during a 6-hours mixed-meal tolerance test (in pmol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution in kinetics of blood lipid profile

Description

Evaluation of triglycerides, total cholesterol, HDL-C, non-HDL-C and LDL-C during a 6-hours mixed-meal tolerance test (in mmol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of kinetics of incretin parameters

Description

Evaluation of glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 during a 2-hours mixed-meal tolerance test (in pg/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of inflammatory parameters (fibrinogen)

Description

Evaluation of fibrinogen before and after a 6-hours mixed-meal tolerance test (in ng/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of inflammatory parameters (IL6, TNFA)

Description

Evaluation of interleukin 6, tumour necrosis factor alpha before and after a 6-hours mixed-meal tolerance test (in pg/ml)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of inflammatory parameters (hs-CRP)

Description

Evaluation high-sensitivity C-reactive protein before and after a 6-hours mixed-meal tolerance test (in mg/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of energy metabolism (respiratory quotient)

Description

Evaluation of respiratory quotient before and after a 6-hours mixed-meal tolerance test (in carbon dioxide (CO2) eliminated / dioxygen (O2) consumed)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of energy metabolism (resting metabolic rate)

Description

Evaluation of resting metabolic rate before and after a 6-hours mixed-meal tolerance test (in kcal/day)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of energy metabolism (energy expenditure)

Description

Evaluation of energy expenditure before and after a 6-hours mixed-meal tolerance test (in kcal/kg/h)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Secondary Outcome Measure Information:

Title

Evolution of Safety parameters (hepatic enzymes)

Description

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT) (in U/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of Safety parameters (AST/ALT ratio)

Description

AST/ALT ratio

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of Safety parameters (albumin)

Description

Albumin (in g/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of Safety parameters (creatinine)

Description

Creatinine (in umol/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of complete blood count (red and white blood cells, platelet)

Description

Red blood cells, white blood cells, platelet (in cells/mm3)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of complete blood count (hemoglobin)

Description

Hemoglobin (in g/L)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of complete blood count (hematocrit)

Description

Hematocrit (in %)

Time Frame

Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Title

Evolution of transcriptomics

Description

RNA sequencing

Time Frame

Baseline and V3 (8 weeks of intervention)

Title

Evolution of metabolomics (amino acids, fatty acids and acylcarnitine species)

Description

Evolution of amino acids, fatty acids and acylcarnitine species (in uM)

Time Frame

Baseline and V3 (8 weeks of intervention)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Body mass index (BMI) between ≥ 27 and < 40 kg/m2 kg/m²; Waist circumference > 94 cm for men and > 80 cm for women; Weight stable within ± 5% in the last three months; Fasting plasma TG ≥ 1.35 OR fasting glycemia ≥ 5.6 and ≤ 6.9 mmol/L OR HbA1c ≥ 5.6 and ≤ 6.4 % Main Exclusion Criteria: Any metabolic disorder requiring pharmacological treatment and susceptible to affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator; Taking medication which may affect the study outcomes (or a medication modification less than 3 months prior to the study); To have taken regularly natural health products or enriched foods susceptible to modify the parameters followed by the investigator within the 3 months prior to the study; With a known or suspected food allergy, intolerance or hypersensitivity to any of the study products' ingredient as well as the non-medicinal ingredients of the product; Consuming more than 4 drinks of alcohol per week; Having a lifestyle deemed incompatible with the study according to the investigator including high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded); Pregnant or lactating women or intending to become pregnant within the timeframe of the study; Fasting blood triglycerides (TG) > 2.5 mmol/L; Fasting blood LDL-C > 4.9mmol/L or non-HDL-C > 5.7 mmol/L; Blood AST ≥ 45 U/L for men; and blood AST ≥ 35 U/L for women; Blood ALT ≥ 60 U/L for men; and blood ALT ≥ 50 U/L for women; Blood GGT ≥ 75 U/L for men; and blood GGT ≥ 50 U/L for women; Blood creatinine concentration > 125 μmol/L AND Estimated Glomerular Filtration Rate (eGFR) (calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) < 60 mL/min/1.73m²; Complete blood count (CBC) with hemoglobin < 120 g/L or leucocytes < 3000 /mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Annie Bouchard-Mercier, PhD

Phone

+1 418-656-2131

Ext

407492

annie.bouchard@valbiotis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maxime Bargetto, MSc

Phone

+33 5 17 06 84 80

m.bargetto@valbiotis.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

André Marette, PhD

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Patrick Couture, MD FRCP PhD

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Nutrition and Funtional Foods (INAF) - Laval University

City

Quebec

ZIP/Postal Code

G1V 0A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julie Marois, MSc

Phone

+1 418-656-2131

Ext

405764

julie.marois@fsaa.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk

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