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

An Open-label, Single Center, Single Arm, Clinical Trial to Assess the Consumption Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk

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.

Study Overview

• Status: Terminated
• Conditions: Atherosclerosis; Dyslipidemias; Hypercholesterolemia; Cardiovascular Risk Factor; Cardio-metabolic Risk
• Intervention / Treatment: Dietary supplement: TOTUM-070

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CIC Clermont Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOTUM-070; Experimental active diet supplement TOTUM-070 taken 2 times per day	Dietary supplement: TOTUM-070; 2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of blood LDL cholesterol concentration at 6 weeks	LDL cholesterol (Friedewald method)	V1 (baseline) and V2 (6 weeks of intervention)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Valbiotis
• Collaborators: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Moderate hypercholesterolemia; Nutrition healthcare; Plant extracts
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Atherosclerosis
• Other Study ID Numbers: VCT-015; 2022-A01474-39 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No