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

Last updated: January 29, 2024
Sponsor: University of Bologna
Overall Status: Completed

Phase

N/A

Condition

Hypercholesterolemia

Treatment

Placebo

Plant sterols 2.5 g/day

Clinical Study ID

NCT05265455
DESCO_2021
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Total cholesterol plasma levels between 200 and 240 mg/dL and/or LDL cholesterollevels 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

Exclusion Criteria:

  • Subjects in secondary prevention for cardiovascular diseases or with a globalcardiovascular 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 2months
  • Alterations in thyroid, hepatic or renal function (transaminases greater than 3 timesthe maximum values; glomerular filtration rate <30ml / min), muscle diseases, even ifsubclinical
  • Obesity (BMI> 30)
  • Any medical or surgical condition that could make the patient's adherence to the studyprotocol complex or inconstant.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
June 08, 2022

Study 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.

Connect with a study center

  • S. Orsola-Malpighi University Hospital

    Bologna, 40038
    Italy

    Site Not Available

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