Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Plant sterols 2.5 g/day
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant sterol supplementation<br>2.5 g of phytosterols in pre-dosed sticks (oral supplementation) | Dietary Supplement: Plant sterols 2.5 g/day<br>* Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation) | Dietary Supplement: Placebo<br>* Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 weeks | 
| Weight | Evaluation of the effects of the intake of phytosterols on weight in kilograms | 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 ) | 3 weeks | 
| Abdominal circumference | Evaluation of the effects of the intake of phytosterols on abdominal circumference | 3 weeks | 
| Blood pressure | Evaluation of the effects of the intake of phytosterols on blood pressure | 3 weeks |