Effects of dietary supplements on cholesterol levels
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
NA · IBSA Farmaceutici Italia Srl · NCT06810466
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | IBSA Farmaceutici Italia Srl (industry) |
| Locations | 1 site (Bologna, Italy) |
| Trial ID | NCT06810466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with mild hypercholesterolemia who have not achieved desired lipid levels through the Mediterranean diet.
Not a fit: Patients with existing cardiovascular disease or those at high risk for cardiovascular events may not benefit from this study.
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 performed: Previous studies have shown promising results with dietary supplements aimed at improving lipid profiles, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Bologna, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypercholesterolemia and Hyperlipidemia, Supplementation, mild hypercholesterolemia, supplement, lipid profile, dietary supplement