Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil
NCT ID: NCT05460221
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-01-01
2024-09-30
Brief Summary
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Detailed Description
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The effects of an optimized oil rich in polyphenols and obtained by mixing varieties rich in said bioactive compounds (approx. 490 ppm), and a functional oil prepared with the same optimized oil and enriched with triterpenic acids obtained from the olive itself (approx. 490 ppm of polyphenols and 380 ppm of triterpenic acids). The study will be carried out in pediatric patients with high levels of untreated blood pressure, in which the effect of oils on blood pressure and their action on biomarkers of cardiovascular risk and on the intestinal microbiota will be evaluated, depending on the genotype specific to each subject. In addition, the presence of minor olive oil compounds present in the plasma will be analyzed (metabolomic analysis). In this way, at the end of the project, verified scientific information will be available on the enriched product and its effects on cardiovascular protection, and on possible mechanisms of action, as well as on its palatability and acceptance.
The general objective of this study is to evaluate the effect of a nutritional intervention with an 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.
As specific objectives will be determined:
* To evaluate the effect of olive oils on blood pressure levels
* To evaluate the effect of olive oils on the levels of other components of the metabolic syndrome.
* To evaluate the effect of olive oils on the antioxidant defense system
* To evaluate the effect of olive oils on biomarkers of cardiovascular risk, including markers of inflammation and endothelial damage.
* To evaluate the effect of olive oils on the intestinal microbiota.
* To evaluate the effect of olive oils on metabolomic changes in plasma.
* To analyze the specific genotype of each volunteer and its relationship with the clinical effects found.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Optimized oil group
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).
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.
Functional oil group
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).
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.
Control Group
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).
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
18 Years
ALL
No
Sponsors
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Complejo Hospitalario Universitario de Santiago
OTHER
Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Universidad de Granada
OTHER
Responsible Party
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María Dolores Mesa García
Professor
Principal Investigators
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MARIA DOLORES MESA GARCIA
Role: PRINCIPAL_INVESTIGATOR
Universidad de Granada
Locations
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Hospital Universitario Reina Sofia de Córdoba
Córdoba, , Spain
Universidad de Granada
Granada, , Spain
Countries
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Other Identifiers
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IDI-20190985
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MEDKIDS_HTA
Identifier Type: -
Identifier Source: org_study_id
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