Effects of bergamot and plant sterols on cholesterol levels
Effect of Dietary Supplement Containing Bergamot and Plant Sterols Extract on Serum Lipid Profile
This study is testing whether taking bergamot fruit extract and plant sterols can help lower cholesterol levels in people with high cholesterol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istanbul Bilgi University Academic / other |
| Locations | 1 site (İstanbul) |
| Trial ID | NCT06929403 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of bergamot fruit extract and plant sterols on the serum lipid profile of individuals with dyslipidemia. Participants will be randomly assigned to receive either a cholesterol-lowering diet, supplements of bergamot with phytosterols, or a combination of both for a duration of 12 weeks. The study aims to assess changes in cholesterol levels and overall lipid profiles, utilizing statistical analyses to evaluate the effectiveness of the interventions. Ethics committee approval has been obtained, and informed consent will be collected from all participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with hyperlipidemia who are suitable for taking dietary supplements.
Not a fit: Patients with chronic liver or kidney diseases, heart failure, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural and effective method for managing cholesterol levels in patients with dyslipidemia.
How similar studies have performed: Previous studies have shown positive effects of plant sterols and bergamot on cholesterol levels, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults individuals who were diagnosed hyperlipidemia * Individuals suitable for taking supplement Exclusion Criteria: * Chronic liver disease, * Chronic kidney disease, * Heart failure, infarction or cerebrovascular disease, * Pregnant and breastfeeding women, * Severe psychiatric disorders, * Oncological diseases, * People using medications that may interact with black seed oil (anticoagulant, antihypertensive, etc.) * People using antilipidemic or anticholesterolemic medications in the last 3 months * People with citrus allergies * People who do not do heavy exercise * People using any dietary supplements * People with a known history of allergies * People who do not regularly consume alcohol * People with special dietary requirements
Where this trial is running
İstanbul
- İstanbul Bilgi University — İstanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Hande Seven Avuk — İstanbul Bilgi University
- Study coordinator: Hande Seve Avuk
- Email: dythandeseven@gmail.com
- Phone: +905303302603
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.