Effects of dietary supplements on cholesterol levels
Official title: A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia
Run by IBSA Farmaceutici Italia Srl · NCT06810466 · Data updated 2026-11-12
This study is testing if two different dietary supplements can help people with mildly high cholesterol who haven't improved with the Mediterranean diet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 69 Years |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | IBSA Farmaceutici Italia Srl Industry-sponsored |
| Locations | 1 site (Bologna, Italy) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT06810466 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with mild hypercholesterolemia who have not achieved desired lipid levels through the Mediterranean diet.
✕Probably not a fit
Patients with existing cardiovascular disease or those at high risk for cardiovascular events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the impact of two different dietary supplement formulations on the lipid profile of individuals with mild hypercholesterolemia who do not respond to the Mediterranean diet. The study involves 99 participants who will be randomly assigned to receive either one of the test products or a placebo over a 16-week period. The first 8 weeks will be a double-blind phase, followed by an open-label phase where all participants will receive the same test product. The goal is to determine if these supplements can effectively improve cholesterol levels.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for patients struggling to manage their cholesterol levels through diet alone.
How similar studies have gone: Previous studies have shown promising results with dietary supplements aimed at improving lipid profiles, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prevention of cardiovascular disease * Low cardiovascular risk (\< 5%) * Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2 * Signature of informed consent. Exclusion Criteria: * Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5) * diabetes mellitus * Taking hypolipemiants, supplements or drugs that may involve lipid metabolism * Hypertension treatment not stabilized for at least 3 months * History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease * Any medical-surgical treatment that may limit adherence to the study protocol * Pregnant and/or breastfeeding women
Where it's running
-
S. Orsola-Malpighi University Hospital
Bologna, Italy, Italy Recruiting
Study contacts
- Study coordinator: Arrigo Francesco Giuseppe Cicero, Prof.
- Email: arrigo.cicero@unibo.it
- Phone: +39 512142224
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.