Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil

University of Granada (UGR)

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Control group; Dietary Supplement: Optimized oil group; Dietary Supplement: Functional oil group

Study type: Interventional

Funder types: Other

Identifiers

NCT05460221

MEDKIDS_HTA

IDI-20190985 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

A clinical study of nutritional intervention, randomized, adjusted by randomization blocks that consider age and sex, and parallel duration of 6 months, in 75 subjects (25 per randomization group) is proposed. The study will be carried out at the UGC of Pediatrics of the Reina Sofía University Hospital in Córdoba, as well as at the Institute of Nutrition and Food Technology of the University of Granada.

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.

Enrollment: 50 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Optimized oil group

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Optimized oil group

Functional oil group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Functional oil group

Control Group

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Control group