Healthy VolunteerLIPIGUARDNCT06894251
Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
A study testing LIMICOL® NG in people with Healthy Volunteer, run by Institut Pasteur de Lille at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- LIMICOL® NG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- Agreeing to follow the constraints generated by the study;
- Having signed the informed consent form;
- Social security insured.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
NutrInvest - Institut Pasteur de Lille
Lille, Nord, 59019
Frédéric Batteux, MD, 3.20.87.73.16 ext. +33, frederic.batteux@pasteur-lille.fr
Coralie Berthier, PhD, 3.20.87.73.33 ext. +33, coralie.berthier@pasteur-lille.fr
About this study
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
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- LIMICOL® NG
- Keywords
- Prevention, Food supplement, Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIMICOL® NGDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: LIMICOL® NG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %).
Measured: To baseline at 3 months
Secondary outcomes (12)
Weight
Anthropometric parameters: weight (unit: kg)
Measured: 0 month (baseline), 1 month, 3 months
Body Mass Index
Anthropometric parameters: determined Body Mass Index (unit: kg/m²)
Measured: 0 month (baseline), 1 month, 3 months
Waist circumference
Waist circumference (unit: cm)
Measured: 0 month (baseline), 1 month, 3 months
Blood pressure
Hemodynamic parameters: Systolic blood pressure (unit: mm Hg) and Diastolic blood pressure (unit: mm Hg)
Measured: 0 month (baseline), 1 month, 3 months
Heart rate
Hemodynamic parameters: Heart rate (unit: Pul/min)
Measured: 0 month (baseline), 1 month, 3 months
Fasting glycemia
Carbohydrate metabolism: Fasting glycemia (unit: g/l)
Measured: 0 month (baseline), 1 month, 3 months
Lipid metabolism
Total cholesterol, HDL, LDL, non-HDL, Triglycerides, LDL/HDL ratio and TC/HDL ratio (unit: g/l)
Measured: 0 month (baseline), 1 month, 3 months
Hepatic metabolism
Creatinine, bilirubin (unit: mg/dl)
Measured: 0 month (baseline), 1 month, 3 months
Transaminases
Hepatic metabolism: ASAT/ALAT, GGT (unit: UI/l)
Measured: 0 month (baseline), 1 month, 3 months
Renal metabolism (Urea)
Renal metabolism: Urea (unit: mg/dl)
Measured: 0 month (baseline), 1 month, 3 months
Renal metabolism (Creatinine Phophoskinase)
Renal metabolism: CPK (unit : UI/l)
Measured: 0 month (baseline), 1 month, 3 months
Renal metabolism (Lactate Deshydrogenase)
Renal metabolism: LDH (unit : UI/l)
Measured: 0 month (baseline), 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start10 Mar 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Group receiving the food supplement
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coralie BERTHIER, Institut Pasteur de Lille
- Investigators
- Frédéric Batteux, MD, Principal investigator, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894251
- Sponsor's protocol ID
- 2024-A01916-41
- Acronym
- LIPIGUARD
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of LIMICOL®-NG on Plasma LDL-cholesterol Concentration in Subjects with Moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT06894251
- Acronym / sponsor ID
- LIPIGUARD / 2024-A01916-41
- Conditions
- Healthy Volunteer
- Keywords
- Prevention, Food supplement, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Group receiving the food supplement
| Arm | Type | Receives |
|---|---|---|
| Food supplement group | Experimental | Dietary Supplement: LIMICOL® NGTwo 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For women
- 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;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIMICOL® NGAll 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. | Dietary supplement | Food supplement group |
Primary outcome
Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol
Time frame: To baseline at 3 months
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 %).
12 secondary outcomes
Weight
Time frame: 0 month (baseline), 1 month, 3 months
Body Mass Index
Time frame: 0 month (baseline), 1 month, 3 months
Waist circumference
Time frame: 0 month (baseline), 1 month, 3 months
Blood pressure
Time frame: 0 month (baseline), 1 month, 3 months
Heart rate
Time frame: 0 month (baseline), 1 month, 3 months
Fasting glycemia
Time frame: 0 month (baseline), 1 month, 3 months
Lipid metabolism
Time frame: 0 month (baseline), 1 month, 3 months
Hepatic metabolism
Time frame: 0 month (baseline), 1 month, 3 months
Transaminases
Time frame: 0 month (baseline), 1 month, 3 months
Renal metabolism (Urea)
Time frame: 0 month (baseline), 1 month, 3 months
Renal metabolism (Creatinine Phophoskinase)
Time frame: 0 month (baseline), 1 month, 3 months
Renal metabolism (Lactate Deshydrogenase)
Time frame: 0 month (baseline), 1 month, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric Batteux, MD principal investigator
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIMICOL® NG in people with Healthy Volunteer, run by Institut Pasteur de Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coralie Berthier, PhD (3 20 87 73 33 ext. +33, coralie.berthier@pasteur-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution over time (from 0 to 3 months) of the plasma concentration of LDL cholesterol (time frame: To baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.