Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil

Hypertension Clinical Trial

Official title:

Antihypertensive and Cardioprotective Clinical Evaluation of a Functional Olive Oil Enriched in Bioactive Compounds From the Olive Tree

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460221
• Other study ID #: MEDKIDS_HTA
• Secondary ID: IDI-20190985
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Universidad de Granada
• Contact: Maria Dolores Mesa-Garcia
• Phone: 958246187
• Email: mdmesa[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofia de Córdoba	Córdoba
Spain	Universidad de Granada	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Granada	Complejo Hospitalario Universitario de Santiago, Hospital Universitario Reina Sofia de Cordoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change n weight from baseline to 6 months	Change from baseline weight (kg) at 6 months. For weight assessment, a Tanita 780PMA model precision scale will be used. It will always be carried out with the patient in underwear, standing on the scale in a standard anatomical position without using any extra point of support that could modify the measurement.; Patients will be measured with the direct reading Harpenden Stadiometer with a wall-mounted indicator counter, measuring 600-2100 mm, approved by the University of London Institute of Child Health; standing on the height rod, without wearing shoes.	0 month; 3 month; 6 month
Secondary	Change on body mass index (BMI) from Baseline to 6 months	To calculate changes in BMI is necessary to determine weight (kilograms) and height (meters).; The body mass index (BMI) or Quetelet index (Weight/Height²) will be stratified according to the International reference values of Cole and Bellizi to classify obesity.	0 month; 3 month; 6 month
Secondary	Change of body composition from Baseline to 6 months	Bioimpedance test will be performed to assess changes on body composition, with emphasis on fat mass, using a Tanita 780PMA model precision scale.	0 month; 3 month; 6 month
Secondary	Dietary intake and eating habits	Assessment of changes on dietary intake will be evaluated at the beginning, 3 and 6 months after the intervention with three 24-hour reminders separated by at least one week in accordance with the EFSA recommendations for this type of study, all of them previously validated. At the beginning of the study, a questionnaire on the frequency of food consumption will be carried out.	0 month; 3 month; 6 month
Secondary	Physical activity	Assessment of changes on physical activity will be assessed at the beginning, 3 and 6 months after the intervention through the PAQ-C Physical Activity questionnaire	0 month; 3 month; 6 month
Secondary	Sedentary activities	Assessment of the level of sedentary activities will be evaluated at the beginning, 3 and 6 months after the intervention through an ad hoc questionnaire on time spent watching television and use of computers, video games and consoles, validated for young children and school children, as well as other socioeconomic determinants	0 month; 3 month; 6 month
Secondary	Hemogram	Changes on blood count will be analyzed on an automated analyzer	0 month; 3 month; 6 month
Secondary	Blood glucose	Changes on blood glucose will be analyzed by the glucose oxidase method on an automated analyzer (Roche-Hitachi Modular P and D Autoanalyser; Roche Laboratory Systems, Mannheim, Germany)	0 month; 3 month; 6 month
Secondary	Blood insulin	Changes on plasma insulin will be analyzed by radioimmunoassay (RIA) using an automated microparticle analyzer. (AxSYM; Abbott Laboratories, Abbott Park, IL, USA).	0 month; 3 month; 6 month
Secondary	Insulin resistance	Changes on insulin resistance (IR) will be calculated by homeostatic model assessment of IR (HOMA-IR).	0 month; 3 month; 6 month
Secondary	Serum triacylglycerides	Changes on serum, triglycerides will be measured using an automatic analyzer ( Roche-Hitachi Modular P and D Autoanalyser; Roche Laboratory Systems, Mannheim, Germany).	0 month; 3 month; 6 month
Secondary	Serum cholesterol	Changes on serum total cholesterol, high-density lipoprotein cholesterol (HDLc) and low-density lipoprotein cholesterol (LDLc), as well as Apoprotein A and B, and Lipoprotein A1 will be measured using an automatic analyzer ( Roche-Hitachi Modular P and D Autoanalyser; Roche Laboratory Systems, Mannheim, Germany).	0 month; 3 month; 6 month
Secondary	Endothelial function biomarkers in blood	Simultaneous detection of endothelial adhesion molecules VCAM-1, ICAM, E-selectin and myeloperoxidase will be performed in children's plasma, using MULTIPLEX assay kits and Luminex xMAP detection technology, which allows us to quantitatively determine several biomarkers using a very small amount of sample (25-50 µl of plasma or serum). The HCVD2MAG-67K kit will be used to determine the adhesion molecules.	0 month; 3 month; 6 month
Secondary	Antioxidant glutathione reductase activity in red blood cells	Assessing changes of glutathione reductase activity will be carried out using standardized spectrophotometric methods.	0 month; 3 month; 6 month
Secondary	Antioxidant glutathione peroxidase activity in red blood cells	Assessing changes of glutathione peroxidase activity will be carried out using standardized spectrophotometric methods.	0 month; 3 month; 6 month
Secondary	Antioxidant superoxide dismutase activity in red blood cells	Assessing changes of superoxide dismutase activity will be carried out using standardized spectrophotometric methods.	0 month; 3 month; 6 month
Secondary	Antioxidant catalase activity in red blood cells	Assessing changes of catalase activity will be carried out using standardized spectrophotometric methods.	0 month; 3 month; 6 month
Secondary	Antioxidant alpha-tocopherol, beta-carotene, retinol and Coenzyme Q in plasma	Assessing changes of plasma antioxidants: alpha-tocopherol, beta-carotene, retinol, and coenzyme Q will be analysed by HPLC-MS in one single inyection	0 month; 3 month; 6 month
Secondary	Urine endothelin-1	Assessing changes of endothelin-1 will be analyzed in plasma using an ELISA kit.	0 month; 3 month; 6 month
Secondary	Analysis of oxLDL in plasma	Assessing changes of oxidized LDL from the baseline to the end of each treatment, by using an ELISA kit	0 month; 3 month; 6 month
Secondary	F2-Isoprostanes in urine	Assessing changes of F2-Isoprostanes will be carried out using an ELISA kit.	0 month; 3 month; 6 month
Secondary	8-hydroxy-deoxy-Guanosine in urine	Assessing changes of 8-hydroxy-deoxy-Guanosine will be carried out using an ELISA kit.	0 month; 3 month; 6 month
Secondary	Metagenomics	Assessing changes of fecal microbiome profile from the baseline to the end of each treatment. Stool DNA will be isolated with the QIAamp DNA stool mimi kit. Amplification of variable region V3-V1 of 16S gen will be sequenced using the Illunina Next Generation Sequencing MiSeg.	0 month; 6 month
Secondary	Plasma metabolomic analysis	A liquid chromatography platform coupled to a spectrophotometer will be used mass (LC/MS) to determine metabolic profiles by targeted analyses	0 month; 6 month
Secondary	Urine metabolomic analysis	A liquid chromatography platform coupled to a spectrophotometer will be used mass (LC/MS) to determine metabolic profiles by targeted analyses	0 month; 3 month; 6 month
Secondary	Genotyping	Genotyping of the main candidate genes related to the development of arterial hypertension described in GWAS studies (ACE, ADRB1, AGT, PHACTR1, EDN1, ATP13A3) will be carried out in the Department of Biochemistry and Molecular Biology II of the University of Granada.	0 month