Status:
COMPLETED
Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)
Lead Sponsor:
University of Bologna
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
DESCO is a randomized clinical trial, controlled against placebo, performed to evaluate the effect of a phytosterol-based product (2.5 g/day), after 3 weeks of intake, on the lipid profile, also in re...
Detailed Description
This is a randomized, placebo-controlled, double-blind, monocentric cross over clinical study conducted in Italy. The objective of this study is to evaluate the fasting lipid profile of adults with m...
Eligibility Criteria
Inclusion
- Total cholesterol plasma levels between 200 and 240 mg/dL and/or LDL cholesterol levels between 130 and 160 mg/dL
- Triglyceride plasma levels \<200 mg / dL
- Cardiovascular risk at 10 years (according to the SCORE algorithm) \<5%.
- Signature of the informed consent form
Exclusion
- Subjects in secondary prevention for cardiovascular diseases or with a global cardiovascular risk (according to the SCORE algorithm) \> 5% at 10 years
- Triglyceride plasma levels \>200 mg / dL
- Decompensated diabetes
- Alcoholism
- Food allergy
- Recent intake of functional foods or supplements for cholesterol control
- Intake of lipid-lowering drugs or drugs affecting lipid metabolism in the last 2 months
- Alterations in thyroid, hepatic or renal function (transaminases greater than 3 times the maximum values; glomerular filtration rate \<30ml / min), muscle diseases, even if subclinical
- Obesity (BMI\> 30)
- Any medical or surgical condition that could make the patient's adherence to the study protocol complex or inconstant.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05265455
Start Date
October 1 2021
End Date
June 8 2022
Last Update
January 31 2024
Active Locations (1)
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1
S. Orsola-Malpighi University Hospital
Bologna, Italy, 40038