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

Atherosclerosis Clinical Trial

— OLALIP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05594979
• Other study ID #: VCT-015
• Secondary ID: 2022-A01474-39
• Status: Terminated
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: September 27, 2023

Study information

• Verified date: February 2024
• Source: Valbiotis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 27, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Risk Factor
• Dyslipidemias
• Hypercholesterolemia

Intervention

Dietary Supplement:
• TOTUM-070
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes

Locations

Country	Name	City	State
France	CIC Clermont Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Valbiotis	University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of blood LDL cholesterol concentration at 6 weeks	LDL cholesterol (Friedewald method)	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of triglycerides	Triglycerides	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of total cholesterol	Total cholesterol	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of HDL cholesterol	HDL cholesterol	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of non-HDL cholesterol	Non-HDL cholesterol	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of free fatty acids	Free fatty acids	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of apolipoprotein-A1	Apolipoprotein-A1	V1 (baseline) and V2 (6 weeks of intervention)
Secondary	Change from baseline of the fasting blood concentration of apolipoprotein-B	Apolipoprotein-B	V1 (baseline) and V2 (6 weeks of intervention)