Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
Study NCT ID:
NCT06894251
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Sponsor:
Institut Pasteur de Lille
Organization:
Study Overview
Official Title:
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIPIGUARD
Brief Summary:
The goal of this clinical trial is to observe a decrease in plasma LDL cholesterol concentration of 10% (or 0.20g/L) in subjects with untreated moderate hypercholesterolemia after 3 months of consumption of the Limicol®-NG food supplement, compared with a historical placebo group
Detailed Description:
The objective is to evaluate the effect of the Limicol®-NG food supplement during the 3 months of taking it (after 1 and 3 months of consumption versus T0) and comparison versus placebo history of the evolution over time (from 0 to 3 months) of the following parameters:
* Weight,
* BMI,
* Waist circumference,
* Systolic and diastolic blood pressures,
* Resting heart rate.
* Fasting blood sugar
* LDL cholesterol
* Non-HDL cholesterol (NHC)
* Total cholesterol (TC)
* HDL cholesterol
* Triglycerides (TG)
* LDL/HDL and TC/HDL ratios,
* Safety parameters measured from blood samples at VS and V2: ASAT, ALAT, Gamma-GT, Creatine Kinase, Lactate DeHydrogenase, Bilirubin, Creatinine, and Urea.
* Weight,
* BMI,
* Waist circumference,
* Systolic and diastolic blood pressures,
* Resting heart rate.
* Fasting blood sugar
* LDL cholesterol
* Non-HDL cholesterol (NHC)
* Total cholesterol (TC)
* HDL cholesterol
* Triglycerides (TG)
* LDL/HDL and TC/HDL ratios,
* Safety parameters measured from blood samples at VS and V2: ASAT, ALAT, Gamma-GT, Creatine Kinase, Lactate DeHydrogenase, Bilirubin, Creatinine, and Urea.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: