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Plant Extracts
TOTUM-63 for Prediabetes
N/A
Waitlist Available
Led By Patrick Couture, MD FRCP PhD
Research Sponsored by Valbiotis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body mass index (BMI) between ≥ 27 and < 40 kg/m2 kg/m²;
Waist circumference > 94 cm for men and > 80 cm for women;
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
Study Summary
This trial will study the effects of a plant extract blend on weight, gut health, and metabolism in overweight and obese people.
Eligible Conditions
- Prediabetes
- Hyperglycemia or Hypoglycemia
- Obesity
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
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)
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evolution in kinetics of blood lipid profile
Evolution in kinetics of glucose metabolism
Evolution in kinetics of insulin secretion
+32 moreSecondary outcome measures
Evolution of Safety parameters (AST/ALT ratio)
Evolution of Safety parameters (albumin)
Evolution of Safety parameters (creatinine)
+6 moreTrial 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?
ValbiotisLead Sponsor
11 Previous Clinical Trials
1,917 Total Patients Enrolled
Laval UniversityOTHER
416 Previous Clinical Trials
172,256 Total Patients Enrolled
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecOTHER
36 Previous Clinical Trials
9,722 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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