CompletedNot Applicable

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

Canada20 participantsStarted 2022-04-25

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main 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; * Fasting plasma TG ≥ 1.35 OR fasting glycemia ≥ 5.6 and ≤ 6.9 mmol/L OR HbA1c ≥ 5.6 and ≤ 6.4 % Main Exclusion Criteria: * Any metabolic disorder requiring pharmacological treatment and susceptible to affect glucose metabolism or plasma lipid levels or that might affect the study outcomes according to the investigator; * Taking medication which may affect the study outcomes (or a medication modification less than 3 months prior to the study); * To have taken regularly natural health products or enriched foods susceptible to modify the parameters followed by the investigator within the 3 months prior to the study; * With a known or suspected food allergy, intolerance or hypersensitivity to any of the study products' ingredient as well as the non-medicinal ingredients of the product; * Consuming more than 4 drinks of alcohol per week; * Having a lifestyle deemed incompatible with the study according to the investigator including high level of physical activity (defined as more than 10 hours of intense physical activity a week, walking excluded); * Pregnant or lactating women or intending to become pregnant within the timeframe of the study; * Fasting blood triglycerides (TG) \> 2.5 mmol/L; * Fasting blood LDL-C \> 4.9mmol/L or non-HDL-C \> 5.7 mmol/L; * Blood AST ≥ 45 U/L for…

What they're measuring

Evolution of blood pressure

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of heart rate

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of weight

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of waist circumference

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of body mass index

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of fasting glycemia

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of insulin secretion

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Trial details

NCT IDNCT05369585

SponsorValbiotis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-12

View on ClinicalTrials.gov More Prediabetic State trials

Who can participate

Age range30 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evolution of blood pressure

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of heart rate

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of weight

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of waist circumference

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of body mass index

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of fasting glycemia

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)

Evolution of insulin secretion

Timeframe: Baseline, V2 (4 weeks of intervention), V3 (8 weeks of intervention) and V4 (8 weeks of intervention + 4 weeks of follow-up)