NCT05265455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

November 24, 2021

Last Update Submit

January 29, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mediterranean index of the diet assessed by validated FFQ

    3 weeks

  • Weight

    3 weeks

  • BMI

    3 weeks

  • Abdominal circumference

    3 weeks

  • Blood pressure

    3 weeks

Study Arms (2)

Plant sterol supplementation

EXPERIMENTAL

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

Dietary Supplement: Plant sterols 2.5 g/day

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Plant sterols 2.5 g/dayDIETARY_SUPPLEMENT

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

Plant sterol supplementation
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, 40038, Italy

Location

Related 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 Randomized Clinical Study. Nutrients. 2023 Oct 27;15(21):4555. doi: 10.3390/nu15214555.

    PMID: 37960208RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2021

First Posted

March 3, 2022

Study Start

October 1, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)