Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia

NCT06894251 | Recruiting

• 1 other identifier: 2024-A01916-41
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteer

Keywords

Prevention; Food supplement; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol

  Historical placebo comparison of the evolution over time (from 0 to 3 months) of plasma LDL cholesterol concentration measured according to the Friedwald method (in g/L and %).

  To baseline at 3 months

Secondary Outcomes (12)

• Weight

  0 month (baseline), 1 month, 3 months

• Body Mass Index

  0 month (baseline), 1 month, 3 months

• Waist circumference

  0 month (baseline), 1 month, 3 months

• Blood pressure

  0 month (baseline), 1 month, 3 months

• Heart rate

  0 month (baseline), 1 month, 3 months

Study Arms (1)

Food supplement group

EXPERIMENTAL

Two tablets of Limicol®-NG per day (1 during or after breakfast and 1 during or after dinner) Food supplements are consumed during 3 months by healthy volunteers

Dietary Supplement: LIMICOL® NG

Interventions

LIMICOL® NG DIETARY_SUPPLEMENT

All subjects will consume 2 tablets per day during the entire intervention period, i.e. 12 weeks between V0 and V2, distributed as follows: 1 tablet in the morning at the end of or after breakfast (no taking on an empty stomach) and 1 tablet in the evening during dinner. If a dose is missed, 2 tablets can be taken at the next dose.

Food supplement group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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;
• 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.

You may not qualify if:

• Subjects receiving hypolipidemic or anti-dyslipidemic treatment (statin, ezetimibe, cholestyramine, fibrate, etc.)
• Subjects presenting triglyceridemia \> 4g/L (Friedewald)
• Subject requiring immediate treatment with statin
• Subject requiring immediate dietary intervention or having fluctuating eating behavior
• Diabetic subjects treated or not with medication
• Subjects 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 (efficacy: LDL, TG, HDL, blood sugar, blood pressure, weight; safety: markers of liver, muscle or kidney function)
• Subjects 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 3 g/day, probiotics)
• Subjects 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 disorders, progressive tumor pathology, blood disease)
• 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.

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Frédéric Batteux, MD

  Institut Pasteur de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coralie Berthier, PhD

CONTACT

3 20 87 73 33; coralie.berthier@pasteur-lille.fr

Frédéric Batteux, MD

CONTACT

3.20.87.73.16; frederic.batteux@pasteur-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group receiving the food supplement

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 25, 2025
• Study Start: March 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

FR (1)