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

University of Bologna

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Plant sterols 2.5 g/day; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05265455

DESCO_2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Plant sterol supplementation

Experimental group

Description:

2.5 g of phytosterols in pre-dosed sticks (oral supplementation)

Treatment:

Dietary Supplement: Plant sterols 2.5 g/day

Placebo

Placebo Comparator group

Description:

Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation)

Treatment:

Dietary Supplement: Placebo