Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
Launched by UNIVERSITY OF VALENCIA · Jun 26, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The Cardiofoodsterol trial is studying whether taking a food supplement that contains plant sterols can help lower cholesterol levels in people who are overweight or obese and have certain blood sugar levels. If you're between the ages of 65 and 74 or 29 and 219, and your LDL cholesterol (the "bad" cholesterol) is higher than 115 mg/dL, you might be eligible to participate. To qualify, you should also have a Body Mass Index (BMI) between 27 and 39.9, and your blood sugar levels should be within specific ranges. However, if you're currently taking medication to lower cholesterol, smoking, drinking more than 30 grams of alcohol a day, or following certain diets, you may not be able to join the study.
If you decide to take part, you'll either receive the plant sterol supplement or a placebo (a fake supplement with no active ingredients) for comparison. This trial is currently looking for participants, and it aims to see how this supplement affects cholesterol and gut health. It's important to know that this study won't involve any medications, and it focuses on dietary changes. If you're interested in participating, you would be contributing to valuable research that could help others with similar health challenges.
Gender
ALL
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
About University Of Valencia
The University of Valencia, a prestigious institution located in Spain, is dedicated to advancing scientific knowledge and improving public health through innovative research. With a strong emphasis on interdisciplinary collaboration, the university engages in a wide array of clinical trials aimed at addressing pressing medical challenges. Its commitment to ethical standards and regulatory compliance ensures the integrity of its research initiatives, while its experienced team of researchers and clinicians work diligently to translate scientific discoveries into practical applications that benefit patients and communities. The University of Valencia is at the forefront of medical research, fostering a culture of excellence and innovation in the pursuit of better healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
Patients applied
Trial Officials
Guadalupe Garcia Llatas, Professor
Principal Investigator
University of Valencia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported