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Official title Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
ClinicalTrials.gov ID: NCT06894251
What this study is testing
- What it's testing
- 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
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- For women
- If pre-menopausal: effective non-estrogenic contraception established for at least 2 cycles, to be maintained during the study,
- If menopausal: without estrogenic Hormone Replacement Therapy (HRT)
- LDL cholesterol \>1.3 g/L (according to Friedewald calculation);
- Having stable eating habits, a level of physical activity and a weight for at least 3 months before the start of the study;
You likely can't join if
- people receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
- people presenting triglyceridemia \> 4g/L (Friedewald)
- Subject requiring immediate treatment with statin
- Subject requiring immediate dietary intervention or having fluctuating eating behavior
- Diabetic people treated or not with medication
- people with unstable treatment (for less than three months), or requiring the implementation of treatment during the study which, according to the...
See the full eligibility criteria
- For women
- If pre-menopausal: effective non-estrogenic contraception established for at least 2 cycles, to be maintained during the study,
- If menopausal: without estrogenic Hormone Replacement Therapy (HRT)
- LDL cholesterol \>1.3 g/L (according to Friedewald calculation);
- Having stable eating habits, a level of physical activity and a weight for at least 3 months before the start of the study;
- Agreeing to maintain their lifestyle habits throughout the duration of the study;
- Agreeing to follow the constraints generated by the study;
- Having signed the informed consent form;
- Social security insured.
- people receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
- people presenting triglyceridemia \> 4g/L (Friedewald)
- Subject requiring immediate treatment with statin
- Subject requiring immediate dietary intervention or having fluctuating eating behavior
- Diabetic people treated or not with medication
- people with unstable treatment (for less than three months), or requiring the implementation of treatment during the study which, according to the investigator, could interfere with the evaluation of the study criteria...
- people who have consumed in the last 3 months food supplements or functional foods that could impact cholesterol or TG levels (phytosterol, phytostanol, red yeast rice, policosanols, beta-glucans at a dose greater than...
- people suffering from a severe chronic condition deemed incompatible with the study by the investigator (serious digestive pathologies, renal failure, coronary pathology, immunodeficiency, heart failure, rhythm...
- Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating disorder)
- Pregnant woman or planning to become pregnant during the study period or breastfeeding
- Whose state of health or concomitant treatments are judged by the principal investigator or a qualified co-investigator to be incompatible with the proper conduct of the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Lille, Nord, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, Nord, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.