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

Hypercholesterolemia Clinical Trial

— DESCO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265455
• Other study ID #: DESCO_2021
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: January 2024
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Plant sterols 2.5 g/day
Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks
• Placebo
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks

Locations

Country	Name	City	State
Italy	S. Orsola-Malpighi University Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Cicero AFG, Fogacci F, Giovannini M, Rizzoli E, Grandi E, D'Addato S, Borghi C. The Effect of Dietary Supplementation with Plant Sterols on Total and LDL-Cholesterol in Plasma Is Affected by Adherence to Mediterranean Diet: Insights from the DESCO Randomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Weight	Evaluation of the effects of the intake of phytosterols on weight in kilograms	3 weeks
Secondary	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
Secondary	Abdominal circumference	Evaluation of the effects of the intake of phytosterols on abdominal circumference	3 weeks
Secondary	Blood pressure	Evaluation of the effects of the intake of phytosterols on blood pressure	3 weeks