TOTUM-63 for Obesity

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a plant-based supplement called TOTUM-63 affects heart health and gut bacteria in individuals who are overweight or obese. Participants will take TOTUM-63 three times daily to determine its impact on cardiometabolic health, including blood sugar and cholesterol levels. It suits those who have been overweight with a stable weight recently and meet specific waist measurements or blood sugar levels. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on natural supplements for heart health.

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.

Is there any evidence suggesting that TOTUM-63 is likely to be safe for humans?

Research has shown that TOTUM-63 is safe and easy to take. In several studies, participants using TOTUM-63 reported no major side effects. Other trials tested the treatment and found no serious health problems. Made from plant extracts, TOTUM-63 helps control blood sugar levels without causing low blood sugar. Overall, evidence suggests that TOTUM-63 is both safe and user-friendly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for cardio-metabolic risk, which often focus on medication or lifestyle changes like diet and exercise, TOTUM-63 is a unique approach that leverages a natural, plant-based composition. Researchers are excited about TOTUM-63 because it targets cardio-metabolic health using a novel mechanism of action, potentially offering a more holistic and side-effect-free option compared to the standard pharmaceuticals. This treatment is taken three times a day, which might integrate well with daily routines, making it easier for people to adhere to the regimen.

What evidence suggests that TOTUM-63 might be an effective treatment for cardiometabolic health in overweight-obese individuals?

Research has shown that TOTUM-63, a blend of plant extracts, may improve heart and metabolic health. In studies, TOTUM-63 significantly lowered fasting blood sugar levels in individuals with prediabetes or early-stage type 2 diabetes over six months. This reduction means it decreased blood sugar levels after fasting. Additionally, participants experienced smaller increases in blood sugar after consuming carbohydrates. These findings suggest that TOTUM-63 may help manage blood sugar levels, which is crucial for those at risk of diabetes and heart issues. Participants in this trial will take TOTUM-63 three times per day to further evaluate its effects. ^{1 2 3 4 6}

Who Is on the Research Team?

André Marette, PhD

Principal Investigator

Laval University

Patrick Couture, MD FRCP PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TOTUM-63

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796323/

TOTUM‐63, a plant‐based polyphenol‐rich extract, improves ... Our results show that the supplementation of TOTUM‐63 for 6 months reduced FPG in individuals with prediabetes or early stage newly diagnosed untreated T2D ...

2. biospace.com biospace.com/valbiotis-sa-valbiotis-presents-the-full-results-of-the-phase-ii-iii-reverse-it-study-impressive-efficacy-of-totum-63-against-prediabetes-and-the-early-stages-of-type-2-diabetes-a-first-for-a-non-drug-active-substance

Impressive Efficacy of TOTUM•63 Against Prediabetes and ... The REVERSE-IT study has met its primary endpoint: TOTUM•63 reduced fasting blood glucose at 6 months versus placebo, on both a 3-intake/day and ...

3. investisseurs.valbiotis.com investisseurs.valbiotis.com/en/totum-63/

TOTUM•63: for the management of prediabetes and early ... The REVERSE-IT study has met its primary endpoint: TOTUM•63 reduced fasting blood glucose at 6 months versus placebo, on both a 3-intake/day and a 2-intake/day ...

4. finance.yahoo.com finance.yahoo.com/news/valbiotis-sa-valbiotis-presents-full-162000234.html

Valbiotis Presents the Full Results of the Phase II/III ... The REVERSE-IT study has met its primary endpoint: TOTUM&bull;63 reduced fasting blood glucose at 6 months versus placebo, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8285600/

Effects of Totum-63 on glucose homeostasis and ... Glycemia following carbohydrate ingestion was significantly reduced (T30 and T45 min) after supplementation, compared to before supplementation.

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.14817?SeriesKey=14631326&af=R&content=articlesChapters&countTerms=true&mi=wdexcv&sortBy=Earliest&target=default

TOTUM‐63, a plant‐based polyphenol‐rich extract, improves ... A pilot exploratory study showed that TOTUM-63 has good safety and tolerability profiles, and beneficial effects on postprandial glucose ...