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

Primary Purpose

Hypercholesterolemia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Plant sterols 2.5 g/day
Placebo
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • S. Orsola-Malpighi University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Plant sterol supplementation

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Weight
Evaluation of the effects of the intake of phytosterols on weight in kilograms
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 )
Abdominal circumference
Evaluation of the effects of the intake of phytosterols on abdominal circumference
Blood pressure
Evaluation of the effects of the intake of phytosterols on blood pressure

Full Information

First Posted
November 24, 2021
Last Updated
February 22, 2022
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT05265455
Brief Title
Diet and Plant Sterols in the Control of Cholesterolemia (DESCO)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plant sterol supplementation
Arm Type
Experimental
Arm Description
2.5 g of phytosterols in pre-dosed sticks (oral supplementation)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation)
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant sterols 2.5 g/day
Intervention Description
Daily consumption of one stick (2.5 g of plant sterols) during lunch or dinner for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks
Primary Outcome Measure Information:
Title
Fasting lipid profile
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Mediterranean index of the diet assessed by validated FFQ
Description
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).
Time Frame
3 weeks
Title
Weight
Description
Evaluation of the effects of the intake of phytosterols on weight in kilograms
Time Frame
3 weeks
Title
BMI
Description
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 )
Time Frame
3 weeks
Title
Abdominal circumference
Description
Evaluation of the effects of the intake of phytosterols on abdominal circumference
Time Frame
3 weeks
Title
Blood pressure
Description
Evaluation of the effects of the intake of phytosterols on blood pressure
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arrigo Cicero, MD
Phone
++39512142224
Email
arrigo.cicero@unibo.it
Facility Information:
Facility Name
S. Orsola-Malpighi University Hospital
City
Bologna
ZIP/Postal Code
40038
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arrigo FG Cicero, MD, PhD
Phone
++39 512142224
Email
arrigo.cicero@unibo.it
First Name & Middle Initial & Last Name & Degree
Arrigo FG Cicero, MD, PhD
Phone
++39 3498558017
Email
afgcicero@gmail.com

12. IPD Sharing Statement

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

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