Status:
COMPLETED
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk
Lead Sponsor:
Valbiotis
Collaborating Sponsors:
Laval University
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions:
Prediabetic State
Dysglycemia
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief 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 i...
Detailed Description
In 2019, over 460 million adults had diabetes worldwide. Moreover, it was estimated by the International Diabetes Federation that about 700 million adults will have type 2 diabetes (T2D) by 2045. Valb...
Eligibility Criteria
Inclusion
- Main
- 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
- 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 men; and blood AST ≥ 35 U/L for women;
- Blood ALT ≥ 60 U/L for men; and blood ALT ≥ 50 U/L for women;
- Blood GGT ≥ 75 U/L for men; and blood GGT ≥ 50 U/L for women;
- Blood creatinine concentration \> 125 μmol/L AND Estimated Glomerular Filtration Rate (eGFR) (calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) \< 60 mL/min/1.73m²;
- Complete blood count (CBC) with hemoglobin \< 120 g/L or leucocytes \< 3000 /mm3 or leucocytes \> 16000 /mm3 or clinically significant abnormality according to the investigator.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05369585
Start Date
April 25 2022
End Date
April 12 2023
Last Update
November 13 2023
Active Locations (1)
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1
Institute of Nutrition and Funtional Foods (INAF) - Laval University
Québec, Canada, G1V 0A6