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

Sponsor

Valbiotis (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05594979

Collaborator

University Hospital, Clermont-Ferrand (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Cardiovascular Risk Factor Dyslipidemias Atherosclerosis Cardio-metabolic Risk	Dietary Supplement: TOTUM-070	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 total cholesterol [V1 (baseline) and V2 (6 weeks of intervention)]
Total cholesterol
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 non-HDL cholesterol [V1 (baseline) and V2 (6 weeks of intervention)]
Non-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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,

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