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

NCT05369585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-13

No results posted yet for this 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.

Conditions

  • Prediabetic State
  • Dysglycemia
  • Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

TOTUM-63

5-g per day dose of TOTUM-63 supplement, a mix of 5 plant extracts. Daily dose for 8 weeks followed by a 4 weeks follow-up period without supplementation.

Sponsors & Collaborators

  • Laval University

    collaborator OTHER

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

    collaborator OTHER

  • Valbiotis Canada inc.

    collaborator UNKNOWN

  • Valbiotis

    lead INDUSTRY

Principal Investigators

  • André Marette, PhD · Laval University

  • Patrick Couture, MD FRCP PhD · Laval University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2023-04-12
Completion
2023-04-12

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369585 on ClinicalTrials.gov