- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05369585
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Annie Bouchard-Mercier, PhD
- Phone Number: 407492 +1 418-656-2131
- Email: annie.bouchard@valbiotis.com
Study Contact Backup
- Name: Maxime Bargetto, MSc
- Phone Number: +33 5 17 06 84 80
- Email: m.bargetto@valbiotis.com
Study Locations
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-
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Quebec, Canada, G1V 0A6
- Recruiting
- Institute of Nutrition and Funtional Foods (INAF) - Laval University
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Contact:
- Julie Marois, MSc
- Phone Number: 405764 +1 418-656-2131
- Email: julie.marois@fsaa.ulaval.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TOTUM-63
Experimental active are supplemented with TOTUM-63, taken 3 times per day.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of blood pressure
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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)
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Evolution of waist circumference
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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)
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Evolution of body mass index
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
Body mass index (in kg/m2)
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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)
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Evolution of fasting glycemia
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Fasting glycemia (in mmol/L)
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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 insulin secretion
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Fasting insulinemia and C-peptide (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)
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Evolution of HbA1c
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
Peptide tyrosine tyrosine (PYY), cholecystokinin (in pg/ml)
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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)
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Evolution of adipokines
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
Adiponectin, leptin, plasminogen activator inhibitor 1 (in ng/ml)
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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)
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Evolution of inflammatory response (fibrinogen)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Fibrinogen (in ng/ml)
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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)
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Evolution of inflammatory response (IL6, TNFa)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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)
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Evolution of inflammatory response (hs-CRP)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
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Evolution of incretin response
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 (in pg/ml)
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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)
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Evolution of blood lipid profile (lipid profile)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Triglycerides, total cholesterol, HDL-C, non-HDL-C, LDL-C, free-fatty-acids (in mmol/L)
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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)
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Evolution of blood lipid profile (oxidized-LDL)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Oxidized-LDL (in ng/ml)
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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)
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Evolution of blood lipid profile (ketones)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Ketones (in umol/L)
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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)
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Evolution of fecal and plasma bile acid profiles
Time Frame: Baseline and V3 (8 weeks of intervention)
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Primary and secondary bile acids profiles (fecal and plasma) (in uM)
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Baseline and V3 (8 weeks of intervention)
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Evolution of metagenomic parameters (whole metagenome shotgun sequencing)
Time Frame: Baseline and V3 (8 weeks of intervention)
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Whole metagenome shotgun sequencing
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Baseline and V3 (8 weeks of intervention)
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Evolution of metagenomic parameters (microbiota diversity)
Time Frame: Baseline and V3 (8 weeks of intervention)
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Microbiota diversity measurements (Shannon index)
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Baseline and V3 (8 weeks of intervention)
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Evolution of metagenomic parameters (microbiota richness)
Time Frame: Baseline and V3 (8 weeks of intervention)
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Microbiota richness measurements (Simpson index)
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Baseline and V3 (8 weeks of intervention)
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Evolution of liver MRI
Time Frame: Baseline and V3 (8 weeks of intervention)
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Liver fat content
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Baseline and V3 (8 weeks of intervention)
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Evolution of FIB-4 index
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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FIB-4 index (FIB-4 index < 1.45 in the context of steatosis allows the exclusion of a clinically significant fibrosis)
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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)
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Evolution of BARD score
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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BARD score (from 0 to 4, with a score of 4 resulting in a higher risk of advanced fibrosis)
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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)
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Evolution of NAFLD fibrosis score
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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NAFLD fibrosis score (< -1.455 low fibrosis probability; -1.455 to 0.676 intermediate score; > 0.676 high probability of fibrosis)
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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)
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Evolution in kinetics of glucose metabolism
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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)
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Evolution in kinetics of insulin secretion
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Evaluation of blood insulin and C-peptide during a 6-hours mixed-meal tolerance test (in pmol/L)
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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 in kinetics of blood lipid profile
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Evaluation of triglycerides, total cholesterol, HDL-C, non-HDL-C and LDL-C during a 6-hours mixed-meal tolerance test (in mmol/L)
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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)
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Evolution of kinetics of incretin parameters
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Evaluation of glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 during a 2-hours mixed-meal tolerance test (in pg/ml)
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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 inflammatory parameters (fibrinogen)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
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Evolution of energy metabolism (respiratory quotient)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Evaluation of respiratory quotient before and after a 6-hours mixed-meal tolerance test (in carbon dioxide (CO2) eliminated / dioxygen (O2) consumed)
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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 energy metabolism (resting metabolic rate)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Evaluation of resting metabolic rate before and after a 6-hours mixed-meal tolerance test (in kcal/day)
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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)
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Evolution of energy metabolism (energy expenditure)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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Evaluation of energy expenditure before and after a 6-hours mixed-meal tolerance test (in kcal/kg/h)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evolution of Safety parameters (hepatic enzymes)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
|
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)
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Evolution of complete blood count (hematocrit)
Time Frame: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)
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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
Time Frame: Baseline and V3 (8 weeks of intervention)
|
RNA sequencing
|
Baseline and V3 (8 weeks of intervention)
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Evolution of metabolomics (amino acids, fatty acids and acylcarnitine species)
Time Frame: Baseline and V3 (8 weeks of intervention)
|
Evolution of amino acids, fatty acids and acylcarnitine species (in uM)
|
Baseline and V3 (8 weeks of intervention)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Couture, MD FRCP PhD, Laval University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-408 (Other Identifier: CERUL)
- 255926 (Other Identifier: Health Canada)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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