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Completed

NCT Number: NCT05265455

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. Orsola-Malpighi University Hospital

Bologna, 40038, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plant sterols 2.5 g/day

Dietary Supplement

Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks

Placebo

Dietary Supplement

Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks

Primary outcomes

  1. Fasting lipid profile

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. Mediterranean index of the diet assessed by validated FFQ

    Time frame: 3 weeks

    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).

  2. Weight

    Time frame: 3 weeks

    Evaluation of the effects of the intake of phytosterols on weight in kilograms

  3. BMI

    Time frame: 3 weeks

    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 )

  4. Abdominal circumference

    Time frame: 3 weeks

    Evaluation of the effects of the intake of phytosterols on abdominal circumference

  5. Blood pressure

    Time frame: 3 weeks

    Evaluation of the effects of the intake of phytosterols on blood pressure

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study 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

Acronym: DESCO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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