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Plant Extracts

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

N/A
Waitlist Available
Led By André Marette, PhD
Research Sponsored by Valbiotis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, v2 (4 weeks of intervention), v3 (8 weeks of intervention) and v4 (8 weeks of intervention + 4 weeks of follow-up)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests TOTUM-63, a mix of five plant extracts, on overweight and obese individuals. It aims to improve heart and metabolic health by helping the body manage energy, process nutrients, and maintain a healthy gut bacteria balance.

Eligible Conditions
  • Incretin Hormones in Polycystic Ovary Syndrome
  • Obesity
  • Prediabetes
  • Hyperglycemia or Hypoglycemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, v2 (4 weeks of intervention), v3 (8 weeks of intervention) and v4 (8 weeks of intervention + 4 weeks of follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, v2 (4 weeks of intervention), v3 (8 weeks of intervention) and v4 (8 weeks of intervention + 4 weeks of follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evolution in kinetics of blood lipid profile
Evolution in kinetics of glucose metabolism
Evolution in kinetics of insulin secretion
+32 more
Secondary study objectives
Evolution of Safety parameters (AST/ALT ratio)
Evolution of Safety parameters (albumin)
Evolution of Safety parameters (creatinine)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TOTUM-63Experimental Treatment1 Intervention
Experimental active are supplemented with TOTUM-63, taken 3 times per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TOTUM-63
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,715 Total Patients Enrolled
ValbiotisLead Sponsor
12 Previous Clinical Trials
1,997 Total Patients Enrolled
Laval UniversityOTHER
434 Previous Clinical Trials
178,618 Total Patients Enrolled
Valbiotis Canada inc.UNKNOWN
1 Previous Clinical Trials
70 Total Patients Enrolled
André Marette, PhDPrincipal InvestigatorLaval University
2 Previous Clinical Trials
110 Total Patients Enrolled
Patrick Couture, MD FRCP PhDPrincipal InvestigatorLaval University
~6 spots leftby Dec 2025
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