Actively Recruiting
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Led by Institut Pasteur de Lille · Updated on 2025-03-25
35
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who are either pre-menopausal using effective non-estrogenic contraception for at least 2 cycles or menopausal without estrogenic hormone replacement therapy
- LDL cholesterol greater than 1.3 g/L
- Stable eating habits, physical activity, and weight for at least 3 months before the study
- Willing to maintain lifestyle habits during the study
- Agree to follow study requirements
- Signed informed consent form
- Social security insured
You will not qualify if you...
- Taking any hypolipidemic or anti-dyslipidemic treatment such as statins, ezetimibe, cholestyramine, fibrates
- Triglycerides level greater than 4 g/L
- Need for immediate statin treatment
- Require immediate dietary intervention or have fluctuating eating behavior
- Diabetic (treated or untreated)
- Unstable treatment or new treatment initiation during study that may affect study evaluations
- Use of cholesterol or triglyceride affecting supplements in the last 3 months (phytosterols, red yeast rice, beta-glucans >3 g/day, probiotics)
- Severe chronic conditions incompatible with study (digestive diseases, kidney failure, heart disease, immunodeficiency, tumors, blood diseases)
- Severe eating disorders (anorexia, bulimia, binge eating)
- Pregnant, planning pregnancy, or breastfeeding
- Health or treatments judged incompatible with study by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NutrInvest - Institut Pasteur de Lille
Lille, Nord, France, 59019
Actively Recruiting
Research Team
C
Coralie Berthier, PhD
CONTACT
F
Frédéric Batteux, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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