Polygenic Hypercholesterolaemia study: Phytosterols
Official title Food Supplement for Individuals With Polygenic Hypercholesterolaemia
ClinicalTrials.gov ID: NCT07918677
What this study is testing
- What it's testing
- Atherogenic dyslipidaemia is a key modifiable determinant of cardiovascular risk.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 75
You may be able to join if
- Male or female aged ≥ 18 years and ≤ 75 years old;
- people in primary prevention for cardiovascular diseases;
- Estimated 10-year cardiovascular risk \< 10%;
- non-HDL cholesterol between 145 and 220 mg/dL, OR
- LDL cholesterol between 115 and 190 mg/dL;
You likely can't join if
- Triglycerides \> 400 mg/dL at screening;
- Type 1 or type 2 diabetes mellitus;
- Current treatment with lipid-lowering drugs;
- Known clinically significant alterations of hepatic and/or renal function;
- Women of childbearing potential not using adequate contraceptive methods;
- Pregnancy and breastfeeding;
See the full eligibility criteria
- Male or female aged ≥ 18 years and ≤ 75 years old;
- people in primary prevention for cardiovascular diseases;
- Estimated 10-year cardiovascular risk \< 10%;
- non-HDL cholesterol between 145 and 220 mg/dL, OR
- LDL cholesterol between 115 and 190 mg/dL;
- people who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- people willing to participate in the study and having dated and signed the informed consent form.
- Triglycerides \> 400 mg/dL at screening;
- Type 1 or type 2 diabetes mellitus;
- Current treatment with lipid-lowering drugs;
- Known clinically significant alterations of hepatic and/or renal function;
- Women of childbearing potential not using adequate contraceptive methods;
- Pregnancy and breastfeeding;
- Any medical or surgical condition that could make adherence to the protocol complex or inconsistent, or could compromise subject safety or the ability to complete the study;
- Known intolerance/hypersensitivity to any component of the investigational products.
The study team makes the final eligibility decision.
Where it is enrolling
- Bologna, Italy, Italy
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, but 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bologna, Italy, Italy. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.