Clinical trial NCT05265455: Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: TREATMENT

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 relation to the quality of the diet, in subjects with moderate hypercholesterolemia and low / moderate global cardiovascular risk.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Fasting lipid profile
timeFrame: 3 weeks
Secondary outcomes:
measure: Mediterranean index of the diet assessed by validated FFQ
timeFrame: 3 weeks
measure: Weight
timeFrame: 3 weeks
measure: BMI
timeFrame: 3 weeks
measure: Abdominal circumference
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
Study officials:
References:
citation: 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.