S. Orsola-Malpighi University Hospital
Bologna, 40038, Italy
NCT Number: NCT05265455
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 relation to the quality of the diet, in subjects with moderate hypercholesterolemia and low / moderate global cardiovascular risk.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Bologna, 40038, Italy
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 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks
Time frame: 3 weeks
Evaluation of the effects of the intake of phytosterols on fasting lipid profile, including the following parameters: total and LDL cholesterol, triglycerides, HDL cholesterol, plasma levels of apolipoproteinB-100.
Time frame: 3 weeks
Assessment of the relationship between the effects of the supplementation with phytosterols and the Mediterranean index of the diet assessed by using a validated food frequency questionnaire (Gnagnarella et al. Nutr Metab Cardiovasc Dis. 2018;28:1140-1147).
Time frame: 3 weeks
Evaluation of the effects of the intake of phytosterols on weight in kilograms
Time frame: 3 weeks
Evaluation of the effects of the intake of phytosterols on BMI (weight kilograms and height meters will be combined to report BMI in kg/m^2 )
Time frame: 3 weeks
Evaluation of the effects of the intake of phytosterols on abdominal circumference
Time frame: 3 weeks
Evaluation of the effects of the intake of phytosterols on blood pressure
University of Bologna
Other
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 Relation to the Quality of the Diet, in Subjects With Moderate Hypercholesterolemia and Low / Moderate Global Cardiovascular Risk
Acronym: DESCO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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