Hypocholesterolemic Effect of a Phytosterol-enriched Spreadable Cream Prepared With Virgin Olive Oil

NCT ID: NCT05460208

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-31

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

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Enriched spread

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)

Group Type: EXPERIMENTAL

Enriched spread

Intervention Type: DIETARY_SUPPLEMENT

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

Control spread

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)

Group Type: PLACEBO_COMPARATOR

Control spread

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Enriched spread

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

Intervention Type: DIETARY_SUPPLEMENT

Control spread

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

María Dolores Mesa García

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARÍA DOLORES MESA GARCÍA

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Hospital Universitario Reina Sofia de Córdoba

Córdoba, , Spain

Universidad de Granada

Granada, , Spain

Countries

Spain

Other Identifiers

IDI-20190983

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MEDKIDS-Chol

Identifier Type: -

Identifier Source: org_study_id