NCT05460208

Brief Summary

This study aims to evaluate the effect of the enriched extra virgin olive oil spread in plant sterols from the olive itself and demonstrate its effect anticholesterolemic and cardioprotective in children and adolescents with hypercholesterolemia.

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 Jan 2021

Geographic Reach
1 country

2 active sites

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

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

March 7, 2022

Last Update Submit

July 14, 2022

Conditions

Hypercholesterolemia

Keywords

Virgin olive oilPlant SterolsHypercholesterolemic childrenOlive oil polyphenols

Outcome Measures

Primary Outcomes (1)

  • Hypercholesterolemia

    Assessing changes of plasma lipids levels from the baseline to the end of each treatment. The serum concentrations of total cholesterol (mg/dL), triglycerides (TG, (mg/dL)), high-density lipoprotein cholesterol (HDLc, (mg/dL)), and low-density lipoprotein cholesterol (LDLc, (mg/dL)), apolipoprotein A1 (Apo-A1, (mg/dL)) and apolipoprotein B (Apo-B, (mg/dL)) will be analyzed by spectrophotometry.

    Month 0; Month 2; Month 3; Month 5

Secondary Outcomes (12)

  • Body composition

    Month 0; Month 2; Month 3; Month 5

  • Body composition percentages

    Month 0; Month 2; Month 3; Month 5

  • Systolic blood pressure

    Month 0; Month 2; Month 3; Month 5

  • Diastolic blood pressure

    Month 0; Month 2; Month 3; Month 5

  • Oxidation biomarkers

    Month 0; Month 2; Month 3; Month 5

  • +7 more secondary outcomes

Study Arms (2)

Enriched spread

EXPERIMENTAL

Children between 20-40 kg will receive a dose of 15 g of the spread (1.2 g/d of plant sterols: 0.06-0.03 g/kg of weight/d) and those with a weight between 40-60 kg will receive two doses of 15 g of the spread (2.4 g/d of plant sterols: 0.06-0.04 g/kg of weight/d)

Dietary Supplement: Enriched spread

Control spread

PLACEBO COMPARATOR

Children between 20-40 kg will receive a dose of 15 g of the spread (1.2 g/d of plant sterols: 0.06-0.03 g/kg of weight/d) and those with a weight between 40-60 kg will receive two doses of 15 g of the spread (2.4 g/d of plant sterols: 0.06-0.04 g/kg of weight/d)

Dietary Supplement: Control spread

Interventions

Enriched spreadDIETARY_SUPPLEMENT

The experimental spread is made with a base made with 90% extra virgin olive oil to which plant sterols are added.

Enriched spread
Control spreadDIETARY_SUPPLEMENT

The control spread will be the same base spread made with extra virgin olive oil without the added plant sterols.

Control spread

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 6 and 18 years
  • Familial hypercholesterolemia
  • Acceptance to participate by signing the informed consent

You may not qualify if:

  • Children under 6 years of age
  • Absence of hypercholesterolemia
  • Children who receive some type of medication to control hypercholesterolemia, blood pressure, levels of glucose or dyslipidemia or any probiotic, which have invalid data for the variables of the present study
  • Not to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Reina Sofia de Córdoba

Córdoba, 14004, Spain

Location

Universidad de Granada

Granada, 18071, Spain

Location

Related Publications (1)

  • Garcia-Perez P, Vazquez-Aguilar A, Sanchez-Rodriguez E, Jurado-Castro JM, Pastor-Villaescusa B, Gil-Campos M, Rangel-Huerta OD, Gil A, Aguilera CM, Mesa MD, Rocchetti G, Lucini L. Chemometrics-guided plasma lipidomics insights underlying the decrease of plasma total cholesterol and LDLc in children with hypercholesterolemia following habitual intake of an EVOO-based phytosterols-enriched spreadable cream. Metabolomics. 2025 Nov 15;21(6):169. doi: 10.1007/s11306-025-02368-3.

    PMID: 41241688DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • MARÍA DOLORES MESA GARCÍA

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 7, 2022

First Posted

July 15, 2022

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)