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

U

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

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

Trial contacts and locations

1

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Central trial contact

Arrigo Cicero, MD

Data sourced from clinicaltrials.gov

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