Clinical trial NCT05594979: Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypercholesterolemia
Cardiovascular Risk Factor
Dyslipidemias
Atherosclerosis
Cardio-metabolic Risk
Keywords: Moderate hypercholesterolemia
Nutrition healthcare
Plant extracts
Lead sponsor: Valbiotis
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2022-10-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline of blood LDL cholesterol concentration at 6 weeks
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
Secondary outcomes:
measure: Change from baseline of the fasting blood concentration of triglycerides
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
measure: Change from baseline of the fasting blood concentration of total cholesterol
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
measure: Change from baseline of the fasting blood concentration of HDL cholesterol
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
measure: Change from baseline of the fasting blood concentration of non-HDL cholesterol
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
measure: Change from baseline of the fasting blood concentration of free fatty acids
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
measure: Change from baseline of the fasting blood concentration of apolipoprotein-A1
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
measure: Change from baseline of the fasting blood concentration of apolipoprotein-B
timeFrame: V1 (baseline) and V2 (6 weeks of intervention)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CIC Clermont Ferrand
Study officials:
References: