Clinical trial NCT05460221: Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil
Official title: Antihypertensive and Cardioprotective Clinical Evaluation of a Functional Olive Oil Enriched in Bioactive Compounds From the Olive Tree
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Extra virgin olive oil
Polyphenols
Triterpenic acids
Hipertensive children
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Santiago
name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2022-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of systolic blood pressure
timeFrame: 0 month; 3 month; 6 month
measure: Change from Baseline Diastolic Blood Pressure at 6 months
timeFrame: 0 month; 3 month; 6 month
Secondary outcomes:
measure: Change n weight from baseline to 6 months
timeFrame: 0 month; 3 month; 6 month
measure: Change on body mass index (BMI) from Baseline to 6 months
timeFrame: 0 month; 3 month; 6 month
measure: Change of body composition from Baseline to 6 months
timeFrame: 0 month; 3 month; 6 month
measure: Dietary intake and eating habits
timeFrame: 0 month; 3 month; 6 month
measure: Physical activity
timeFrame: 0 month; 3 month; 6 month
measure: Sedentary activities
timeFrame: 0 month; 3 month; 6 month
measure: Hemogram
timeFrame: 0 month; 3 month; 6 month
measure: Blood glucose
timeFrame: 0 month; 3 month; 6 month
measure: Blood insulin
timeFrame: 0 month; 3 month; 6 month
measure: Insulin resistance
timeFrame: 0 month; 3 month; 6 month
measure: Serum triacylglycerides
timeFrame: 0 month; 3 month; 6 month
measure: Serum cholesterol
timeFrame: 0 month; 3 month; 6 month
measure: Endothelial function biomarkers in blood
timeFrame: 0 month; 3 month; 6 month
measure: Antioxidant glutathione reductase activity in red blood cells
timeFrame: 0 month; 3 month; 6 month
measure: Antioxidant glutathione peroxidase activity in red blood cells
timeFrame: 0 month; 3 month; 6 month
measure: Antioxidant superoxide dismutase activity in red blood cells
timeFrame: 0 month; 3 month; 6 month
measure: Antioxidant catalase activity in red blood cells
timeFrame: 0 month; 3 month; 6 month
measure: Antioxidant alpha-tocopherol, beta-carotene, retinol and Coenzyme Q in plasma
timeFrame: 0 month; 3 month; 6 month
measure: Urine endothelin-1
timeFrame: 0 month; 3 month; 6 month
measure: Analysis of oxLDL in plasma
timeFrame: 0 month; 3 month; 6 month
measure: F2-Isoprostanes in urine
timeFrame: 0 month; 3 month; 6 month
measure: 8-hydroxy-deoxy-Guanosine in urine
timeFrame: 0 month; 3 month; 6 month
measure: Metagenomics
timeFrame: 0 month; 6 month
measure: Plasma metabolomic analysis
timeFrame: 0 month; 6 month
measure: Urine metabolomic analysis
timeFrame: 0 month; 3 month; 6 month
measure: Genotyping
timeFrame: 0 month
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia de Córdoba
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
affiliation: Universidad de Granada
name: MARIA DOLORES MESA GARCIA
role: PRINCIPAL_INVESTIGATOR
References: