Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)
NCT ID: NCT05265455
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-10-01
2022-06-08
Brief Summary
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Detailed Description
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The objective of this study is to evaluate the fasting lipid profile of adults with moderate hypercholesterolemia and a low/very low cardiovascular risk, after 3 weeks of supplementation with 2.5 g/day of plant sterols, vs placebo, and to assess the relationship between the effects of the supplementation and the diet.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Plant sterol supplementation
2.5 g of phytosterols in pre-dosed sticks (oral supplementation)
Plant sterols 2.5 g/day
Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks
Placebo
Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation)
Placebo
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks
Interventions
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Plant sterols 2.5 g/day
Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks
Placebo
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Triglyceride plasma levels \<200 mg / dL
* Cardiovascular risk at 10 years (according to the SCORE algorithm) \<5%.
* Signature of the informed consent form
Exclusion Criteria
* 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.
20 Years
65 Years
ALL
Yes
Sponsors
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University of Bologna
OTHER
Responsible Party
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Claudio Borghi
Professor
Locations
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S. Orsola-Malpighi University Hospital
Bologna, , Italy
Countries
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References
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Cicero AFG, Fogacci F, Giovannini M, Rizzoli E, Grandi E, D'Addato S, Borghi C. The Effect of Dietary Supplementation with Plant Sterols on Total and LDL-Cholesterol in Plasma Is Affected by Adherence to Mediterranean Diet: Insights from the DESCO Randomized Clinical Study. Nutrients. 2023 Oct 27;15(21):4555. doi: 10.3390/nu15214555.
Other Identifiers
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DESCO_2021
Identifier Type: -
Identifier Source: org_study_id
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