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

Overseen By Annie Bouchard-Mercier, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Valbiotis

Must not be taking: Metabolic disorder drugs

Disqualifiers: Metabolic disorders, Alcohol, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that could affect the study outcomes, or have changed medications in the last 3 months. If you are on such medications, you may need to stop them to participate.

Research Team

André Marette, PhD

Principal Investigator

Laval University

Patrick Couture, MD FRCP PhD

Principal Investigator

Laval University

Eligibility Criteria

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;

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TOTUM-63, a mix of 5 plant extracts, three times per day for 8 weeks

8 weeks

3 visits (in-person) at Baseline, V2, and V3

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at V4

Treatment Details

Interventions

• TOTUM-63

Participant Groups

Group I: TOTUM-63 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Valbiotis

Lead Sponsor

Trials

13

Recruited

2,000+

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Collaborator

Trials

37

Recruited

9,700+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Valbiotis Canada inc.

Collaborator

Trials

2

Recruited

90+