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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05265455
Recruitment Status : Completed
First Posted : March 3, 2022
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Claudio Borghi, University of Bologna

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Plant sterols 2.5 g/day Dietary Supplement: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : June 8, 2022
Actual Study Completion Date : June 8, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Plant sterol supplementation
2.5 g of phytosterols in pre-dosed sticks (oral supplementation)
 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 Comparator: Placebo
Placebo in pre-dosed sticks (the same matrix without plant sterols) (oral supplementation)
 Dietary Supplement: Placebo
Daily consumption of one stick (the same matrix without plant sterols) during lunch or dinner for 3 weeks


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05265455


Locations
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Italy
S. Orsola-Malpighi University Hospital
Bologna, Italy, 40038
Sponsors and Collaborators
University of Bologna
More Information
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Publications of Results:

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Responsible Party: Claudio Borghi, Professor, University of Bologna
ClinicalTrials.gov Identifier: NCT05265455    
Other Study ID Numbers: DESCO_2021
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases