Effects of plant sterols on cholesterol and cardiovascular health
Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population
This study tests if taking a daily plant sterol supplement can lower cholesterol levels and improve heart health in overweight or obese people with high LDL cholesterol who aren't on any cholesterol medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT06481020 on ClinicalTrials.gov |
What this trial studies
This study evaluates the potential cholesterol-lowering effects of a daily intake of a plant sterol-containing food supplement in overweight or obese individuals with elevated LDL-cholesterol levels. Participants will be randomly assigned to receive either the plant sterol supplement or a placebo, and their LDL-cholesterol serum levels will be monitored over the course of the study. The research aims to understand how plant sterols may influence cardiovascular risk factors, inflammation, and gut microbiota. The study focuses on individuals who are not currently on cholesterol-lowering medications and have specific metabolic profiles.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese individuals with LDL-cholesterol levels greater than 115 mg/dL who are not on cholesterol-lowering medications.
Not a fit: Patients currently on cholesterol-lowering medications, smokers, or those with certain gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological approach to lowering cholesterol and reducing cardiovascular risk in overweight and obese patients.
How similar studies have performed: Previous studies have shown beneficial effects of plant sterols on cholesterol levels, indicating that this approach has been tested with some success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI: 27-29.9 or 30-39.9 * Plasmatic glucose: \< 100mg/dl or 100-125mg/dl * Glycosylated hemoglobin: \< 5.7 or 5.7-6.4 * LDL cholesterol \> 115mg/dL * Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges. Exclusion Criteria: * Subjects on cholesterol-lowering pharmacological treatment * Smokers * Alcohol consumption above 30 g/day * Pregnant or lactating women * Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances) * Diseases of the gastrointestinal tract * Antibiotic, hormonal or anabolic treatment * Participants consuming foods enriched with PS or food supplements that contain PS * Participants who follow specialist weight loss diets, vegans or vegetarians
Where this trial is running
Valencia
- Hospital Universitario y Politécnico La Fe de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Guadalupe Garcia Llatas, Professor — University of Valencia
- Study coordinator: Guadalupe Garcia Llatas, Professor
- Email: guadalupe.garcia@uv.es
- Phone: +34 963543766
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.