Clinical trial NCT05460208: Hypocholesterolemic Effect of a Phytosterol-enriched Spreadable Cream Prepared With Virgin Olive Oil
Official title: Hypocholesterolemic and Cardioprotective Clinical Evaluation of a Spreadable Cream Prepared With Virgin Olive Oil Enriched in Phytosterols and Bioactive Compounds From Olives in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Virgin olive oil
Plant Sterols
Hypercholesterolemic children
Olive oil polyphenols
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
name: Maimónides Biomedical Research Institute of Córdoba
First posted: 2022-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: A clinical study of nutritional intervention, randomized with double blind, adjusted by randomization blocks that consider age and sex, and crossover of 2 months duration each period, with 1-month washout period, in 50 subjects (25 per randomization group). The study will be carried out in the Reina Sofía Universitary Hospital of Córdoba, as well as at the Institute of Nutrition and Food Technology of the University of Granada.

The effects of the enriched spread in patients on the lipid profile will be evaluated plasma and its action on biomarkers of cardiovascular risk and on the microbiota intestinal depending on the specific genotype of each subject. In addition, the presence of minor olive oil compounds present in plasma (metabolomic analysis). In this way, at the end of the project, scientific information will be available contrasted on the enriched product and its effects on cardiovascular protection, in addition to its palatability and acceptance.

The main objective is 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.

As specific objectives will be determined:

* To evaluate the effect of the enriched spread on the plasmatic concentrations of total cholesterol, LDLc and other parameters of the lipid profile
* To evaluate the effect of the enriched spread on the oxidative status of LDL plasmatic
* To evaluate the effect of the enriched spread on the antioxidant defense system
* To evaluate the effect of the enriched spread on biomarkers of cardiovascular risk, including inflammatory and endothelial damage markers
* To evaluate the effect of the enriched spread on the intestinal microbiota.
* To evaluate the effect of the enriched spread on the metabolomic changes in plasma.
* To analyze the specific genotype of each volunteer

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hypercholesterolemia
timeFrame: Month 0; Month 2; Month 3; Month 5
Secondary outcomes:
measure: Body composition
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Body composition percentages
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Systolic blood pressure
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Diastolic blood pressure
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Oxidation biomarkers
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Enzymatic antioxidant status
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Non-enzymatic antioxidant status
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Endothelial function status
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Endothelial damage
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Fecal microbiome
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Plasma metabolomic analysis
timeFrame: Month 0; Month 2; Month 3; Month 5
measure: Urine metabolomic analysis
timeFrame: Month 0; Month 2; Month 3; Month 5
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia de Córdoba
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
affiliation: Universidad de Granada
name: MARÍA DOLORES MESA GARCÍA
role: PRINCIPAL_INVESTIGATOR
References: