Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil

Summary

The general objective of this study is to evaluate the effect of a nutritional intervention with an extra virgin olive oil (EVOO) rich in bioactive compounds (polyphenols) and a functional oil of adequate organoleptic quality, prepared with the same EVOO rich in polyphenols and also enriched in triterpenic acid compounds from the olive itself, and demonstrate its antihypertensive and cardioprotective effect in children and adolescents (between 6-18 years) at risk of untreated hypertension.

Conditions

• Hypertension

Interventions

DIETARY_SUPPLEMENT

Optimized oil group

This is a controlled parallel study. The patient will receive 25 mL/day of three different types of olive oils with different amouns of bioactive compounds from the olive tree, that must be consumed throughout the day at breakfast or snack (depending on the habits of each child). The doses that they do not take must be returned to the hospital staff to assess adherence to the intervention. The families will receive the same type of oil so that they can cook with it during the study period. The control oil will be the same extra virgin olive oil washed to decrease bioactive components (approx. 125 ppm). The intervention will take place for 6 months.

DIETARY_SUPPLEMENT

Functional oil group

This is a controlled parallel study. The patient will receive 25 mL/day of three different types of olive oils with different amouns of bioactive compounds from the olive tree, that must be consumed throughout the day at breakfast or snack (depending on the habits of each child). The doses that they do not take must be returned to the hospital staff to assess adherence to the intervention. The families will receive the same type of oil so that they can cook with it during the study period. The control oil will be the same extra virgin olive oil washed to decrease bioactive components (approx. 125 ppm). The intervention will take place for 6 months.

DIETARY_SUPPLEMENT

Control group

This is a controlled parallel study. The patient will receive 25 mL/day of three different types of olive oils with different amouns of bioactive compounds from the olive tree, that must be consumed throughout the day at breakfast or snack (depending on the habits of each child). The doses that they do not take must be returned to the hospital staff to assess adherence to the intervention. The families will receive the same type of oil so that they can cook with it during the study period. The control oil will be the same extra virgin olive oil washed to decrease bioactive components (approx. 125 ppm). The intervention will take place for 6 months.

Sponsors & Collaborators

• Complejo Hospitalario Universitario de Santiago

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Universidad de Granada

  lead OTHER

Principal Investigators

• MARIA DOLORES MESA GARCIA · Universidad de Granada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-12-31

Completion

2024-09-30

Countries

• Spain

Study Locations