An interventional study of Placebo and Combined Dietary Supplement (Normolip® colesterolo) in Polygenic Hypercholesterolaemia, sponsored by ESI. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by ESI · Not applicable, Interventional, and Treatment
Atherogenic dyslipidaemia is a key modifiable determinant of cardiovascular risk. Non-HDL-C provides a comprehensive estimate of atherogenic cholesterol burden. In primary prevention, adults with polygenic hypercholesterolaemia often require dietary and lifestyle interventions, but these may not yield sufficient lipid improvements.
This study evaluates the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, versus placebo, on non-HDL-C change in adults with polygenic hypercholesterolaemia. The three-arm design assesses the primary placebo-controlled comparison and the incremental effect of the combined formulation.
Secondary analyses explore changes in lipid fractions and inflammatory indices. An open-label extension evaluates changes through 12 weeks. The goal is to provide evidence for well-tolerated adjunctive options for lipid management.
Atherogenic dyslipidaemia is a major modifiable determinant of cardiovascular risk in primary prevention. Although low-density lipoprotein cholesterol (LDL-C) is a key therapeutic target, non-high-density lipoprotein cholesterol (non-HDL-C) provides a more comprehensive estimate of atherogenic cholesterol burden because it includes cholesterol carried by all apoB-containing lipoproteins, including remnant lipoproteins. For this reason, non-HDL-C is a clinically relevant endpoint, particularly in individuals with mixed lipid patterns.
In routine practice, many adults present with a lipid phenotype consistent with polygenic hypercholesterolaemia, characterized by moderately elevated LDL-C and/or non-HDL-C in the absence of monogenic familial hypercholesterolaemia. In these subjects, especially when overall cardiovascular risk is low-to-moderate and pharmacological lipid-lowering therapy is not indicated or is deferred, lifestyle and dietary measures represent first-line management. However, lifestyle interventions may be insufficient to achieve meaningful lipid improvements in all individuals, supporting the need for well-tolerated adjunctive approaches suitable for real-world use.
Plant sterols (phytosterols) reduce intestinal cholesterol absorption and have demonstrated lipid-lowering effects. Additional natural compounds such as bergamot and artichoke extracts have been proposed to provide complementary actions on lipid metabolism, potentially enhancing the overall improvement in atherogenic cholesterol when combined with phytosterols. Nevertheless, comparative evidence directly benchmarking phytosterols alone versus a combined formulation and versus placebo under rigorous double-blind conditions is limited.
This study is designed to evaluate, in adults with polygenic hypercholesterolaemia in primary prevention, the efficacy of a combined nutraceutical (phytosterols + bergamot dry extract + artichoke dry extract) and phytosterols alone, compared with placebo, on change in non-HDL-C after 6 weeks of double-blind treatment. The three-arm design allows assessment of the primary placebo-controlled comparison and the incremental effect versus phytosterols alone. Secondary analyses will explore changes across the three arms in lipid fractions and selected inflammatory and liver-related indices (including hsCRP, RCII, LAP, HSI and FLI).
An open-label extension in which all participants receive the combined nutraceutical for a further 6 weeks is included to describe changes through 12 weeks and to characterize response patterns according to the initial randomized allocation under conditions closer to routine clinical use.
ESI is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weeks 0-6: placebo, 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily.
Other: Placebo · Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo)
Weeks 0-6: phytosterols, 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily.
Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo) · Dietary Supplement: Phytosterols
Weeks 0-6: combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily. Weeks 6-12: open-label combined dietary supplement (Normolip® colesterolo), 2 tablets orally once daily.
Dietary Supplement: Combined Dietary Supplement (Normolip® colesterolo)
Participants will take two tablets orally once daily, preferably with a main meal, during Phase 1 (weeks 0-6). Placebo tablets are matched in appearance, packaging, and labelling to the active study products.
Participants will take two tablets orally once daily, preferably with a main meal. During Phase 1 (weeks 0-6), this intervention is administered according to randomization (Normolip® colesterolo). During Phase 2 (weeks 6-12), all participants will receive the combined dietary supplement (Normolip® colesterolo) in an open-label extension. Each tablet contains 800 mg plant sterols, 170 mg bergamot dry extract (standardized to 36% flavanones; corresponding to naringin 61.2 mg), and 50 mg artichoke dry extract (standardized to 2.5% caffeoylquinic acids as chlorogenic acid; corresponding to chlorogenic acid 1.25 mg).
Participants will take two tablets orally once daily, preferably with a main meal, during Phase 1 (weeks 0-6). Each tablet contains 800 mg of plant sterols.
Change from baseline in non-HDL cholesterol at 6 weeks (Day 42)
Change in non-HDL cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing combined nutraceutical versus placebo.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in total cholesterol at 6 weeks (Day 42)
Change in plasma total cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in HDL-C at 6 weeks (Day 42)
Change in plasma HDL cholesterol (HDL-C) from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in triglycerides at 6 weeks (Day 42)
Change in plasma triglycerides from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in LDL-C at 6 weeks (Day 42)
Change in plasma LDL cholesterol (LDL-C) from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in remnant cholesterol at 6 weeks (Day 42)
Change in plasma remnant cholesterol from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in high-sensitivity C-reactive protein (hsCRP) at 6 weeks (Day 42)
Change in plasma hsCRP from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Remnant Cholesterol Inflammatory Index (RCII) at 6 weeks (Day 42)
Change in RCII from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Lipid Accumulation Product (LAP) at 6 weeks (Day 42)
Change in LAP from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Hepatic Steatosis Index (HSI) at 6 weeks (Day 42)
Change in HSI from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change from baseline in Fatty Liver Index (FLI) at 6 weeks (Day 42)
Change in FLI from baseline (T0) to end of double-blind treatment (T1, Day 42), comparing the three treatment arms.
Time frame: Baseline (T0) to 6 weeks (T1, Day 42)
Change in non-HDL cholesterol during open-label extension (Day 42 to Day 84)
Change in non-HDL cholesterol from end of double-blind phase (T1, Day 42) to end of open-label extension (T2, Day 84), when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses will be stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in total cholesterol during open-label extension (Day 42 to Day 84)
Change in plasma total cholesterol from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in HDL-C during open-label extension (Day 42 to Day 84)
Change in plasma HDL-C from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in triglycerides during open-label extension (Day 42 to Day 84)
Change in plasma triglycerides from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in LDL-C during open-label extension (Day 42 to Day 84)
Change in plasma LDL-C from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in remnant cholesterol during open-label extension (Day 42 to Day 84)
Change in plasma remnant cholesterol from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in hsCRP during open-label extension (Day 42 to Day 84)
Change in plasma hsCRP from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in RCII during open-label extension (Day 42 to Day 84)
Change in Remnant Cholesterol Inflammatory Index (RCII) from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in LAP during open-label extension (Day 42 to Day 84)
Change in Lipid Accumulation Product (LAP) from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in HSI during open-label extension (Day 42 to Day 84)
Change in Hepatic Steatosis Index (HSI) from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
Change in FLI during open-label extension (Day 42 to Day 84)
Change in Fatty Liver Index (FLI) from T1 (Day 42) to T2 (Day 84) during open-label extension when all participants receive the combined nutraceutical (2 tablets/day). Descriptive analyses stratified by initial randomized group.
Time frame: Day 42 (T1) to Day 84 (T2)
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Studies of the drug tested here: Phytosterols
ESI