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

Valbiotis

Status: Terminated

Conditions: Dyslipidemias; Hypercholesterolemia; Cardio-metabolic Risk; Cardiovascular Risk Factor; Atherosclerosis

Treatments: Dietary Supplement: TOTUM-070

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05594979

VCT-015

2022-A01474-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

TOTUM-070

Experimental group

Description:

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

Treatment:

Dietary Supplement: TOTUM-070