NCT06481020 Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
| NCT ID | NCT06481020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2024-05-21 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values \> 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.
Eligibility 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
Contact & Investigator
Guadalupe Garcia Llatas, Professor
PRINCIPAL INVESTIGATOR
University of Valencia
Frequently Asked Questions
Who can join the NCT06481020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06481020 currently recruiting?
Yes, NCT06481020 is actively recruiting participants. Contact the research team at guadalupe.garcia@uv.es for enrollment information.
Where is the NCT06481020 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06481020 clinical trial?
NCT06481020 is sponsored by University of Valencia. The principal investigator is Guadalupe Garcia Llatas, Professor at University of Valencia. The trial plans to enroll 42 participants.