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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05594979
Other study ID # VCT-015
Secondary ID 2022-A01474-39
Status Terminated
Phase N/A
First received
Last updated
Start date December 14, 2022
Est. completion date September 27, 2023

Study information

Verified date February 2024
Source Valbiotis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date September 27, 2023
Est. primary completion date September 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Main Inclusion Criteria: - Body mass index (BMI) between 18.5 and 35 kg/m² - Moderate hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain…) and not requiring immediate pharmacological lipid-lowering treatment according to the current recommendations (European Society of Cardiology /European Atherosclerosis Society, 2019) - Fasting blood LDL cholesterol level (using Friedewald estimation method) between 1.3 and 1.9 g/L - Fasting blood triglycerides level = 2.2 g/L Main Exclusion Criteria: - Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations - Suffering from an uncontrolled arterial hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg) - With a history of ischemic cardiovascular event - Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, ongoing hepatic or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease) - Fasting glucose plasma concentration > 1.26 g/L

Study Design


Intervention

Dietary Supplement:
TOTUM-070
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes

Locations

Country Name City State
France CIC Clermont Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
Valbiotis University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline of blood LDL cholesterol concentration at 6 weeks LDL cholesterol (Friedewald method) V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of triglycerides Triglycerides V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of total cholesterol Total cholesterol V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of HDL cholesterol HDL cholesterol V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of non-HDL cholesterol Non-HDL cholesterol V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of free fatty acids Free fatty acids V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of apolipoprotein-A1 Apolipoprotein-A1 V1 (baseline) and V2 (6 weeks of intervention)
Secondary Change from baseline of the fasting blood concentration of apolipoprotein-B Apolipoprotein-B V1 (baseline) and V2 (6 weeks of intervention)
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