TOTUM-63 for Prediabetic State

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Institute of Nutrition and Funtional Foods (INAF) - Laval University, Quebec, Canada
Prediabetic State+3 More
TOTUM-63 - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Prediabetic State
  • Obesity
  • Dysglycaemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prediabetic State

Study Objectives

35 Primary · 9 Secondary · Reporting Duration: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Week 8
Evolution of fecal and plasma bile acid profiles
Evolution of liver MRI
Evolution of metabolomics (amino acids, fatty acids and acylcarnitine species)
Evolution of metagenomic parameters (microbiota diversity)
Evolution of metagenomic parameters (microbiota richness)
Evolution of metagenomic parameters (whole metagenome shotgun sequencing)
Evolution of transcriptomics
Week 8
Evolution in kinetics of blood lipid profile
Evolution in kinetics of glucose metabolism
Evolution in kinetics of insulin secretion
Evolution of BARD score
Evolution of FIB-4 index
Evolution of HbA1c
Evolution of NAFLD fibrosis score
Evolution of Safety parameters (AST/ALT ratio)
Evolution of Safety parameters (albumin)
Evolution of Safety parameters (creatinine)
Evolution of Safety parameters (hepatic enzymes)
Evolution of adipokines
Evolution of blood lipid profile (ketones)
Evolution of blood lipid profile (lipid profile)
Evolution of blood lipid profile (oxidized-LDL)
Evolution of blood pressure
Evolution of body mass index
Evolution of complete blood count (hematocrit)
Evolution of complete blood count (hemoglobin)
Evolution of complete blood count (red and white blood cells, platelet)
Evolution of energy metabolism (energy expenditure)
Evolution of energy metabolism (respiratory quotient)
Evolution of energy metabolism (resting metabolic rate)
Evolution of fasting glycemia
Evolution of heart rate
Evolution of incretin response
Evolution of inflammatory parameters (IL6, TNFA)
Evolution of inflammatory parameters (fibrinogen)
Evolution of inflammatory parameters (hs-CRP)
Evolution of inflammatory response (IL6, TNFa)
Evolution of inflammatory response (fibrinogen)
Evolution of inflammatory response (hs-CRP)
Evolution of insulin secretion
Evolution of kinetics of incretin parameters
Evolution of satiety hormones
Evolution of waist circumference
Evolution of weight

Trial Safety

Safety Progress

1 of 3

Other trials for Prediabetic State

Trial Design

1 Treatment Group

TOTUM-63
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: TOTUM-63 · No Placebo Group · N/A

TOTUM-63
DietarySupplement
Experimental Group · 1 Intervention: TOTUM-63 · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, v2 (4 weeks of intervention), v3 (8 weeks of intervention) and v4 (8 weeks of intervention + 4 weeks of follow-up)
Closest Location: Institute of Nutrition and Funtional Foods (INAF) - Laval University · Quebec, Canada
N/AFirst Recorded Clinical Trial
1 TrialsResearching Prediabetic State
0 CompletedClinical Trials

Who is running the clinical trial?

Laval UniversityOTHER
381 Previous Clinical Trials
154,166 Total Patients Enrolled
2 Trials studying Prediabetic State
2,548 Patients Enrolled for Prediabetic State
Valbiotis Canada inc.UNKNOWN
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
35 Previous Clinical Trials
9,502 Total Patients Enrolled
ValbiotisLead Sponsor
8 Previous Clinical Trials
1,660 Total Patients Enrolled
2 Trials studying Prediabetic State
666 Patients Enrolled for Prediabetic State
Patrick Couture, MD FRCP PhDPrincipal InvestigatorLaval University
André Marette, PhDPrincipal InvestigatorLaval University
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a waist circumference of 94 cm or more for men and 80 cm or more for women.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.