search
Back to results

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

Primary Purpose

Hypercholesterolemia, Cardiovascular Risk Factor, Dyslipidemias

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TOTUM-070
Sponsored by
Valbiotis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Moderate hypercholesterolemia, Nutrition healthcare, Plant extracts

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CIC Clermont FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOTUM-070

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline of blood LDL cholesterol concentration at 6 weeks
LDL cholesterol (Friedewald method)

Secondary Outcome Measures

Change from baseline of the fasting blood concentration of triglycerides
Triglycerides
Change from baseline of the fasting blood concentration of total cholesterol
Total cholesterol
Change from baseline of the fasting blood concentration of HDL cholesterol
HDL cholesterol
Change from baseline of the fasting blood concentration of non-HDL cholesterol
Non-HDL cholesterol
Change from baseline of the fasting blood concentration of free fatty acids
Free fatty acids
Change from baseline of the fasting blood concentration of apolipoprotein-A1
Apolipoprotein-A1
Change from baseline of the fasting blood concentration of apolipoprotein-B
Apolipoprotein-B

Full Information

First Posted
October 21, 2022
Last Updated
June 7, 2023
Sponsor
Valbiotis
Collaborators
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT05594979
Brief Title
Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valbiotis
Collaborators
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Cardiovascular Risk Factor, Dyslipidemias, Atherosclerosis, Cardio-metabolic Risk
Keywords
Moderate hypercholesterolemia, Nutrition healthcare, Plant extracts

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TOTUM-070
Arm Type
Experimental
Arm Description
Experimental active diet supplement TOTUM-070 taken 2 times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
TOTUM-070
Intervention Description
2.5-g dose of TOTUM-070 diet supplement; Four capsules per day to consume orally in two intakes
Primary Outcome Measure Information:
Title
Change from baseline of blood LDL cholesterol concentration at 6 weeks
Description
LDL cholesterol (Friedewald method)
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Secondary Outcome Measure Information:
Title
Change from baseline of the fasting blood concentration of triglycerides
Description
Triglycerides
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Title
Change from baseline of the fasting blood concentration of total cholesterol
Description
Total cholesterol
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Title
Change from baseline of the fasting blood concentration of HDL cholesterol
Description
HDL cholesterol
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Title
Change from baseline of the fasting blood concentration of non-HDL cholesterol
Description
Non-HDL cholesterol
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Title
Change from baseline of the fasting blood concentration of free fatty acids
Description
Free fatty acids
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Title
Change from baseline of the fasting blood concentration of apolipoprotein-A1
Description
Apolipoprotein-A1
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)
Title
Change from baseline of the fasting blood concentration of apolipoprotein-B
Description
Apolipoprotein-B
Time Frame
V1 (baseline) and V2 (6 weeks of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gisèle Pickering, MD, PhD
Phone
473178412
Ext
+33
Email
nmacian@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime Bargetto, MSc
Phone
517068480
Ext
+33
Email
m.bargetto@valbiotis.com
Facility Information:
Facility Name
CIC Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs