Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil

NCT05460221 | Completed

• 2 other identifiers: MEDKIDS_HTAIDI-20190985
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Extra virgin olive oil; Polyphenols; Triterpenic acids; Hipertensive children

Outcome Measures

Primary Outcomes (2)

• Changes of systolic blood pressure

  Changes on systolic blood pressure will be measured at the beginning, 3 and 6 months after the intervention. It will be measured in a sitting position and after 5 minutes of rest, using an OMRON HEM 705 CP device, with the cuff adapted to each child, on the left arm. Systolic and diastolic blood pressure will be measured in duplicate, and the mean of both measurements will be recorded, in millimeters of mercury.

  0 month; 3 month; 6 month

• Change from Baseline Diastolic Blood Pressure at 6 months

  Changes on systolic and diastolic blood pressure will be measured at the beginning, 3 and 6 months after the intervention. It will be measured in a sitting position and after 5 minutes of rest, using an OMRON HEM 705 CP device, with the cuff adapted to each child, on the left arm. Systolic and diastolic blood pressure will be measured in duplicate, and the mean of both measurements will be recorded, in millimeters of mercury.

  0 month; 3 month; 6 month

Secondary Outcomes (26)

• Change n weight from baseline to 6 months

  0 month; 3 month; 6 month

• Change on body mass index (BMI) from Baseline to 6 months

  0 month; 3 month; 6 month

• Change of body composition from Baseline to 6 months

  0 month; 3 month; 6 month

• Dietary intake and eating habits

  0 month; 3 month; 6 month

• Physical activity

  0 month; 3 month; 6 month

Study Arms (3)

Optimized oil group

ACTIVE COMPARATOR

Each participant will consume 25 mL/day during 6 months of an Optimized extra virgin olive oil obtained by mixing different varieties of oils rich in bioactive compounds (it contains approx. 490 ppm of bioactive compounds).

Dietary Supplement: Optimized oil group

Functional oil group

EXPERIMENTAL

Each participant will consume 25 mL/day during 6 months of a Functional olive oil prepared with the same Optimized oil and enriched with triterpenic acids obtained from the olive tree (approx. 490 ppm of polyphenols and 380 ppm of triterpenic acids).

Dietary Supplement: Functional oil group

Control Group

PLACEBO COMPARATOR

Each participant will consume 25 mL/day during 6 months of a Control extra virgin olive oil prepared from the same Optimized oil washed to eliminate bioactive compounds (approx. 125 ppm of polyphenols).

Dietary Supplement: Control group

Interventions

Optimized oil group DIETARY_SUPPLEMENT

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.

Optimized oil group

Functional oil group DIETARY_SUPPLEMENT

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.

Functional oil group

Control group DIETARY_SUPPLEMENT

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.

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 6 and 18 years Percentile levels compatible with arterial hypertension or very high risk (SBP and/or DBP over P90) Without previous medication for hypertension Acceptance to participate by signing the informed consent

You may not qualify if:

• Children under 6 years of age Absence of hypertension Children who require or receive some type of medication to control blood pressure, glucose levels or dyslipidemia or any probiotic Not to sign the informed consent.

Sponsors & Collaborators

• Universidad de Granada: lead
• Complejo Hospitalario Universitario de Santiago: collaborator
• Hospital Universitario Reina Sofia de Cordoba: collaborator

Study Sites (2)

Hospital Universitario Reina Sofia de Córdoba

Córdoba, 14004, Spain

Location

Universidad de Granada

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• MARIA DOLORES MESA GARCIA

  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: PARALLEL
• 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, 2022
• Primary Completion: December 31, 2023
• Study Completion: September 30, 2024
• Last Updated: April 1, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)