HypertensionNCT05460221
Antihypertensive and Cardioprotective Evaluation of a Functional Olive Oil
A study testing Optimized oil group and Functional oil group in people with Hypertension, run by Universidad de Granada at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Optimized oil group and Functional oil group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Reina Sofia de Córdoba
Córdoba, 14004
Universidad de Granada
Granada, 18071
About this study
Official title: Antihypertensive and Cardioprotective Clinical Evaluation of a Functional Olive Oil Enriched in Bioactive Compounds From the Olive Tree
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Optimized oil group, Functional oil group, Control group
- Keywords
- Extra virgin olive oil, Polyphenols, Triterpenic acids, Hipertensive children
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized oil groupDietary 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 groupDietary 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 groupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0 month; 3 month; 6 month
Secondary outcomes (26)
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.
Measured: 0 month; 3 month; 6 month
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.
Measured: 0 month; 3 month; 6 month
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.
Measured: 0 month; 3 month; 6 month
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.
Measured: 0 month; 3 month; 6 month
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
Measured: 0 month; 3 month; 6 month
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
Measured: 0 month; 3 month; 6 month
Hemogram
Changes on blood count will be analyzed on an automated analyzer
Measured: 0 month; 3 month; 6 month
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)
Measured: 0 month; 3 month; 6 month
Blood insulin
Changes on plasma insulin will be analyzed by radioimmunoassay (RIA) using an automated microparticle analyzer. (AxSYM; Abbott Laboratories, Abbott Park, IL, USA).
Measured: 0 month; 3 month; 6 month
Insulin resistance
Changes on insulin resistance (IR) will be calculated by homeostatic model assessment of IR (HOMA-IR).
Measured: 0 month; 3 month; 6 month
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).
Measured: 0 month; 3 month; 6 month
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).
Measured: 0 month; 3 month; 6 month
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.
Measured: 0 month; 3 month; 6 month
Antioxidant glutathione reductase activity in red blood cells
Assessing changes of glutathione reductase activity will be carried out using standardized spectrophotometric methods.
Measured: 0 month; 3 month; 6 month
Antioxidant glutathione peroxidase activity in red blood cells
Assessing changes of glutathione peroxidase activity will be carried out using standardized spectrophotometric methods.
Measured: 0 month; 3 month; 6 month
Antioxidant superoxide dismutase activity in red blood cells
Assessing changes of superoxide dismutase activity will be carried out using standardized spectrophotometric methods.
Measured: 0 month; 3 month; 6 month
Antioxidant catalase activity in red blood cells
Assessing changes of catalase activity will be carried out using standardized spectrophotometric methods.
Measured: 0 month; 3 month; 6 month
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
Measured: 0 month; 3 month; 6 month
Urine endothelin-1
Assessing changes of endothelin-1 will be analyzed in plasma using an ELISA kit.
Measured: 0 month; 3 month; 6 month
Analysis of oxLDL in plasma
Assessing changes of oxidized LDL from the baseline to the end of each treatment, by using an ELISA kit
Measured: 0 month; 3 month; 6 month
F2-Isoprostanes in urine
Assessing changes of F2-Isoprostanes will be carried out using an ELISA kit.
Measured: 0 month; 3 month; 6 month
8-hydroxy-deoxy-Guanosine in urine
Assessing changes of 8-hydroxy-deoxy-Guanosine will be carried out using an ELISA kit.
Measured: 0 month; 3 month; 6 month
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.
Measured: 0 month; 6 month
Plasma metabolomic analysis
A liquid chromatography platform coupled to a spectrophotometer will be used mass (LC/MS) to determine metabolic profiles by targeted analyses
Measured: 0 month; 6 month
Urine metabolomic analysis
A liquid chromatography platform coupled to a spectrophotometer will be used mass (LC/MS) to determine metabolic profiles by targeted analyses
Measured: 0 month; 3 month; 6 month
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.
Measured: 0 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Santiago, Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Principal investigator, María Dolores Mesa García, Universidad de Granada
- Investigators
- MARIA DOLORES MESA GARCIA, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460221
- Sponsor's protocol ID
- MEDKIDS_HTA
- Other IDs
- IDI-20190985
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive and Cardioprotective Clinical Evaluation of a Functional Olive Oil Enriched in Bioactive Compounds From the Olive Tree
- ClinicalTrials.gov ID
- NCT05460221
- Acronym / sponsor ID
- MEDKIDS_HTA
- Conditions
- Hypertension
- Keywords
- Extra virgin olive oil, Polyphenols, Triterpenic acids, Hipertensive children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Santiago, Hospital Universitario Reina Sofia de Cordoba
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Optimized oil group | Active comparator | Dietary Supplement: Optimized oil groupEach 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). |
| Functional oil group | Experimental | Dietary Supplement: Functional oil groupEach 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). |
| Control Group | Placebo comparator | Dietary Supplement: Control groupEach 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). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized oil groupThis 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. | Dietary supplement | Optimized oil group |
| Functional oil groupThis 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. | Dietary supplement | Functional oil group |
| Control groupThis 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. | Dietary supplement | Control Group |
Primary outcome
Changes of systolic blood pressure
Time frame: 0 month; 3 month; 6 month
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.
Change from Baseline Diastolic Blood Pressure at 6 months
Time frame: 0 month; 3 month; 6 month
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.
26 secondary outcomes
Change n weight from baseline to 6 months
Time frame: 0 month; 3 month; 6 month
Change on body mass index (BMI) from Baseline to 6 months
Time frame: 0 month; 3 month; 6 month
Change of body composition from Baseline to 6 months
Time frame: 0 month; 3 month; 6 month
Dietary intake and eating habits
Time frame: 0 month; 3 month; 6 month
Physical activity
Time frame: 0 month; 3 month; 6 month
Sedentary activities
Time frame: 0 month; 3 month; 6 month
Hemogram
Time frame: 0 month; 3 month; 6 month
Blood glucose
Time frame: 0 month; 3 month; 6 month
Blood insulin
Time frame: 0 month; 3 month; 6 month
Insulin resistance
Time frame: 0 month; 3 month; 6 month
Serum triacylglycerides
Time frame: 0 month; 3 month; 6 month
Serum cholesterol
Time frame: 0 month; 3 month; 6 month
Endothelial function biomarkers in blood
Time frame: 0 month; 3 month; 6 month
Antioxidant glutathione reductase activity in red blood cells
Time frame: 0 month; 3 month; 6 month
Antioxidant glutathione peroxidase activity in red blood cells
Time frame: 0 month; 3 month; 6 month
Antioxidant superoxide dismutase activity in red blood cells
Time frame: 0 month; 3 month; 6 month
Antioxidant catalase activity in red blood cells
Time frame: 0 month; 3 month; 6 month
Antioxidant alpha-tocopherol, beta-carotene, retinol and Coenzyme Q in plasma
Time frame: 0 month; 3 month; 6 month
Urine endothelin-1
Time frame: 0 month; 3 month; 6 month
Analysis of oxLDL in plasma
Time frame: 0 month; 3 month; 6 month
F2-Isoprostanes in urine
Time frame: 0 month; 3 month; 6 month
8-hydroxy-deoxy-Guanosine in urine
Time frame: 0 month; 3 month; 6 month
Metagenomics
Time frame: 0 month; 6 month
Plasma metabolomic analysis
Time frame: 0 month; 6 month
Urine metabolomic analysis
Time frame: 0 month; 3 month; 6 month
Genotyping
Time frame: 0 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA DOLORES MESA GARCIA principal investigator
Universidad de Granada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized oil group and Functional oil group in people with Hypertension, run by Universidad de Granada at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of systolic blood pressure (time frame: 0 month; 3 month; 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.