Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk

Not Applicable

Terminated

• Conditions: Hypercholesterolemia; Cardiovascular Risk Factor; Dyslipidemias; Atherosclerosis; Cardio-metabolic Risk
• Interventions: Dietary Supplement: TOTUM-070

• Registration Number: NCT05594979
• Lead Sponsor: Valbiotis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-26
• Study Start: 2022-12-14
• Primary Completion: 2023-09-06
• Study Completion: 2023-09-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOTUM-070	TOTUM-070	Experimental active diet supplement TOTUM-070 taken 2 times per day

Primary Outcome Measures

Name	Time	Method
Change from baseline of blood LDL cholesterol concentration at 6 weeks	V1 (baseline) and V2 (6 weeks of intervention)	LDL cholesterol (Friedewald method)

Secondary Outcome Measures

Name	Time	Method
Change from baseline of the fasting blood concentration of total cholesterol	V1 (baseline) and V2 (6 weeks of intervention)	Total cholesterol
Change from baseline of the fasting blood concentration of apolipoprotein-A1	V1 (baseline) and V2 (6 weeks of intervention)	Apolipoprotein-A1
Change from baseline of the fasting blood concentration of apolipoprotein-B	V1 (baseline) and V2 (6 weeks of intervention)	Apolipoprotein-B
Change from baseline of the fasting blood concentration of non-HDL cholesterol	V1 (baseline) and V2 (6 weeks of intervention)	Non-HDL cholesterol
Change from baseline of the fasting blood concentration of triglycerides	V1 (baseline) and V2 (6 weeks of intervention)	Triglycerides
Change from baseline of the fasting blood concentration of HDL cholesterol	V1 (baseline) and V2 (6 weeks of intervention)	HDL cholesterol
Change from baseline of the fasting blood concentration of free fatty acids	V1 (baseline) and V2 (6 weeks of intervention)	Free fatty acids

Trial Locations

Locations (1)

CIC Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France