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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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
S. Orsola-Malpighi University Hospital
Bologna, Italy
Fasting lipid profile
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
Mediterranean index of the diet assessed by validated FFQ
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
Weight
Evaluation of the effects of the intake of phytosterols on weight in kilograms
Time frame: 3 weeks
BMI
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
Abdominal circumference
Evaluation of the effects of the intake of phytosterols on abdominal circumference
Time frame: 3 weeks
Blood pressure
Evaluation of the effects of the intake of phytosterols on blood pressure
Time frame: 3 weeks
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