Healthy NutritionHEVOOCNCT05898113
Effect of the Intake of Corbella Extra Virgin Olive Oil on the Microbiota-gut-brain Axis in Healthy Adults (HEVOOC)
A study testing EXTRA VIRGIN OLIVE OIL and OLIVE OIL LOW POLYPHENOL in people with Healthy Nutrition, run by University of Barcelona at 1 site in Spain.
Trial summary
The consumption of the improved extra virgin olive oil (EVOO) of the Corbella variety could have a beneficial effect on the microbiota-intestine-brain axis (MGBA). Olive oil contains polyphenols that are not present in other oils, notably oleocanthal and oleacein, which behave similarly to ibuprofen and have a… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- EXTRA VIRGIN OLIVE OIL and OLIVE OIL LOW POLYPHENOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2023to 24 Nov 2023
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult with Body mass index (BMI) < 30 kg/m2
- Signed informed consent
Who cannot join
- Any chronic disease (e.g. cardiovascular disease, cancer or diabetes)
- Mental disorders (e.g. depression, dementia, autism, etc.)
- Cardiovascular alterations in cholesterol,triglycerides, glucose, etc.
- Current smokers
- Repeated use of antibiotics
- Frequent use of corticoids, nonsteroidal anti-inflammatory drugs
Show all 10Show fewer
- Repeated use of vitamins
- Volunteers with extreme eating habits (i.e. Atkins diet, very high protein diets, etc.)
- Excessive alcohol consumption (>30 g/d for males and >20 g/d for females),
- Pregnant, lactating, and postmenopausal women
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.
Barcelona, Barcelona, 08028
About this study
Official title: Development of Oil with Healthy Properties Based on Corbella Olive Variety (HEVOOC)
The consumption of the improved extra virgin olive oil (EVOO) of the Corbella variety could have a beneficial effect on the microbiota-intestine-brain axis (MGBA). Olive oil contains polyphenols that are not present in other oils, notably oleocanthal and oleacein, which behave similarly to ibuprofen and have a protective effect on some neurodegenerative diseases. The polyphenols of the oil present prebiotic characteristics, at the level of the intestinal microbiota, which metabolizes them forming bioactive metabolites that can have a modulating effect on the MGBA, improving brain health. In this study, the researchers seek to identify the benefits of the consumption of Corbella variety EVOO on MGBA in healthy participants. The overall benefit of the study would be to achieve knowledge that would allow its future applicability to prevent and improve certain diseases and in general contribute to optimal health.
Read the detailed description
To evaluate possible effects on MGBA, a randomized, controlled, crossover nutritional trial will be conducted. Thirty healthy adult participants (between 18 and 35 years of age, with 50% male and 50% female) will be included according to the estimated sample size. Participants will consume a daily amount of 0.7 g Corbella EVOO/kg body weight plus their normal diet (experimental intervention) and 0.7 g refined olive oil (ROO)/kg body weight plus their normal diet (control intervention) for 1 month. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hour urine, feces and saliva) will be obtained at baseline and at the end of each trial arm.
- Conditions
- Healthy Nutrition
- Being tested
- EXTRA VIRGIN OLIVE OIL, OLIVE OIL LOW POLYPHENOL
- Keywords
- Extra virgin olive oil, Microbiota, Polyphenol, MGBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXTRA VIRGIN OLIVE OILOther
Participants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked
OLIVE OIL LOW POLYPHENOLOther
Participants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked
| Study group | Role | What they receive |
|---|---|---|
| EXTRA VIRGIN (intervention / control) | Experimental | After a 3-day run in period avoiding EVOO consumption, participants will consume a daily amount of 0.7 g EVOO / kg body weight in addition to their usual diet for 1 months. They will then have 4 weeks with their usual diet and another 3-day run in period before starting the control intervention, which consists of following their usual diet plus 0.7 g olive oil low of polyphenol (OOLP)/ kg body weight daily for one month. Receives: Other: EXTRA VIRGIN OLIVE OIL; Other: OLIVE OIL LOW POLYPHENOL |
| LOW POLYPHENOL (control/intervention) | Experimental | After a 3-day run-in period avoiding EVOO consumption, participants will consume a daily amount of 0.7 g of OOLP/ kg body weight in addition to their usual diet for 1 month. Then, they will have 4 weeks with their usual diet and another run in period of 3 days before starting the intervention which consists of following their usual diet plus 0.7 g of EVOO / kg body weight daily for one month. Receives: Other: EXTRA VIRGIN OLIVE OIL; Other: OLIVE OIL LOW POLYPHENOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain-derived neurotrophic factor (BDNF) after each intervention with EVOO and the control intervention.
Serum samples will be analysed for mature BDNF using a Mature BDNF Rapid ELISA kit.
Measured: Baseline and after completed each intervention (1 month)
Changes in the gut microbiota after each intervention with EVOO and the control intervention.
Fecal samples will be collected by the volunteers using a system for easy self-collection and stabilization of microbial DNA for gut microbiome profiling (OMNIgene - GUT). The extraction of genomic DNA from fecal samples will be carried out utilizing the DNeasy Power Kit. Subsequently, microbial profiling will employ 16 S ribosomal RNA (rRNA) sequencing to investigate microbial communities, with a specific focus on bacterial phylogeny and taxonomy.
Measured: Baseline and after completed each intervention (1 month)
Changes in the polyphenols and their metabolites after each intervention with EVOO and the control intervention.
Polyphenols and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using high performance liquid chromatography (HPLC) - Linear Trap Quadrupole (LTQ) Orbitrap-MS/MS and HPLC-MS/MS techniques.
Measured: Baseline and after completed each intervention (1 month)
Changes in carotenoids and their metabolites after each intervention with EVOO and the control intervention.
Carotenoids and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using high performance liquid chromatography (HPLC) - Linear Trap Quadrupole (LTQ) Orbitrap-MS/MS and HPLC-MS/MS techniques.
Measured: Baseline and after completed each intervention (1 month)
Changes in the short-chain fatty acids in plasma and feces samples after each intervention with EVOO and the control intervention.
After acidifying the fecal samples with formic acid, a quantification of short-chain fatty acids will be performed using gas chromatography by direct injection according to previously described methodology (Zhao et al., 2006).
Measured: Baseline and after completed each intervention (1 month)
Changes in bile acids in plasma and feces samples after each intervention with EVOO and the control intervention.
Bile acids will be assayed using a validated liquid chromatography-mass spectrometry (LC-MS) method
Measured: Baseline and after completed each intervention (1 month)
Changes in cerebrovascular function after each intervention with EVOO and the control intervention.
Cerebrovascular function will be measured using functional magnetic resonance imaging (FMRI), a non-invasive method for assessing brain activity. FMRI maps blood oxygenation levels in the brain and estimates changes in the blood flow that depends on metabolic function and is correlated with specific brain region activities
Measured: Baseline and after completed each intervention (1 month)
Secondary outcomes (17)
Changes in body weight after each intervention with EVOO and the control intervention.
Body weight in kilograms (kg)
Measured: Baseline and after completed each intervention (1 month)
Changes in body mass index (BMI) after each intervention with EVOO and the control intervention.
BMI will be calculated as body weight (kg) divided by height (m). Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and after completed each intervention (1 month)
Changes in hip circumference after each intervention with EVOO and the control intervention.
It will be measured with a tape-measure in triplicate, in centimeters (cm)
Measured: Baseline and after completed each intervention (1 month)
Changes in waist circumference after each intervention with EVOO and the control intervention.
It will be measured with a tape-measure in triplicate, in centimeters (cm)
Measured: Baseline and after completed each intervention (1 month)
Changes in body composition after each intervention with EVOO and the control intervention.
Body fat percentage will be measured using a bioelectrical impedance analysis monitor.
Measured: Baseline and after completed each intervention (1 month)
Changes in blood pressure after each intervention with EVOO and the control intervention.
Diastolic and systolic blood pressure will be measured by a blood pressure monitor in triplicate.
Measured: Baseline and after completed each intervention (1 month)
Changes in heart rate after each intervention with EVOO and the control intervention.
Heart rate (bpm) will be measured with an automatic monitor in triplicate.
Measured: Baseline and after completed each intervention (1 month)
Changes in lipidic profile after each intervention with EVOO and the control intervention.
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mg/dL) will be measured by molecular absorption spectrometry.
Measured: Baseline and after completed each intervention (1 month)
Changes in liver function after each intervention with EVOO and the control intervention.
Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and albumin will be assayed by immunoenzymatic methods.
Measured: Baseline and after completed each intervention (1 month)
Changes in glucose after each intervention with EVOO and the control intervention.
Glucose (mg/dL) will be measured by molecular absorption spectrometry.
Measured: Baseline and after completed each intervention (1 month)
Assessing variations in inflammatory biomarkers post-intervention for both EVOO treatments and the control group.
Cytokines (pg/mL) will be assayed by immunoenzymatic methods.
Measured: Baseline and after completed each intervention (1 month)
Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
Tumor necrosis factor α (TNF-α) (pg/mL) will be assayed by immunoenzymatic methods.
Measured: Baseline and after completed each intervention (1 month)
Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.
Measured: Baseline and after completed each intervention (1 month)
Changes in nutrients and energy intake after each intervention with EVOO and the control intervention.
A 7-day food recall will be used. The data will be analyzed using a software called Professional Nutritional Calculation Program (PCN Pro)
Measured: Baseline and after completed each intervention (1 month)
Changes in quality of the diet after each intervention with EVOO and the control intervention.
Participants will fill the validated Mediterranean Diet Adherence Screener (MEDAS) questionnaire used in the PREDIMED study. This questionnaire has been validated for the Spanish population and assesses adherence to the Mediterranean diet.The MEDAS score can range from 0 to 17 and higher scores mean better outcome.
Measured: Baseline and after completed each intervention (1 month)
Changes in physical activity after each intervention with EVOO and the control intervention.
Physical activity will be assessed with the ActiGraph® wGT3X-BT accelerometer
Measured: Baseline and after completed each intervention (1 month)
Changes in sleep quality after each intervention with EVOO and the control intervention
Sleep quality will be assessed with the ActiGraph® wGT3X-BT accelerometer.
Measured: Baseline and after completed each intervention (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start19 Jun 2023
- Primary completion10 Aug 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1. EXPERIMENTAL: Extra virgin olive oil (EVOO): should add 0.7 g of Corbella EVOO/ kg body weight to their usual diet per day, either raw or cooked, for one month 2. CONTROL: Olive oil low in polyphenols (OOLP): should add 0.7 g of OOLP/ kg body weight to their usual diet per day, either raw or cooked, for one month
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Responsible party
- Principal investigator, Rosa M Lamuela-Raventós, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898113
- Sponsor's protocol ID
- ID-20210929
- Acronym
- HEVOOC
- Status last verified
- Mar 2025
- First submitted
- 17 May 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Development of Oil with Healthy Properties Based on Corbella Olive Variety (HEVOOC)
- ClinicalTrials.gov ID
- NCT05898113
- Acronym / sponsor ID
- HEVOOC / ID-20210929
- Conditions
- Healthy Nutrition
- Keywords
- Extra virgin olive oil, Microbiota, Polyphenol, MGBA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 12 Jun 2023 (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 consumption of the improved extra virgin olive oil (EVOO) of the Corbella variety could have a beneficial effect on the microbiota-intestine-brain axis (MGBA). Olive oil contains polyphenols that are not present in other oils, notably oleocanthal and oleacein, which behave similarly to ibuprofen and have a protective effect on some neurodegenerative diseases. The polyphenols of the oil present prebiotic characteristics, at the level of the intestinal microbiota, which metabolizes them forming bioactive metabolites that can have a modulating effect on the MGBA, improving brain health. In this study, the researchers seek to identify the benefits of the consumption of Corbella variety EVOO on MGBA in healthy participants. The overall benefit of the study would be to achieve knowledge that would allow its future applicability to prevent and improve certain diseases and in general contribute to optimal health.
Detailed description
To evaluate possible effects on MGBA, a randomized, controlled, crossover nutritional trial will be conducted. Thirty healthy adult participants (between 18 and 35 years of age, with 50% male and 50% female) will be included according to the estimated sample size. Participants will consume a daily amount of 0.7 g Corbella EVOO/kg body weight plus their normal diet (experimental intervention) and 0.7 g refined olive oil (ROO)/kg body weight plus their normal diet (control intervention) for 1 month. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hour urine, feces and saliva) will be obtained at baseline and at the end of each trial arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. EXPERIMENTAL: Extra virgin olive oil (EVOO): should add 0.7 g of Corbella EVOO/ kg body weight to their usual diet per day, either raw or cooked, for one month 2. CONTROL: Olive oil low in polyphenols (OOLP): should add 0.7 g of OOLP/ kg body weight to their usual diet per day, either raw or cooked, for one month
| Arm | Type | Receives |
|---|---|---|
| EXTRA VIRGIN (intervention / control) | Experimental | Other: EXTRA VIRGIN OLIVE OIL, Other: OLIVE OIL LOW POLYPHENOLAfter a 3-day run in period avoiding EVOO consumption, participants will consume a daily amount of 0.7 g EVOO / kg body weight in addition to their usual diet for 1 months. They will then have 4 weeks with their usual diet and another 3-day run in period before starting the control intervention, which consists of following their usual diet plus 0.7 g olive oil low of polyphenol (OOLP)/ kg body weight daily for one month. |
| LOW POLYPHENOL (control/intervention) | Experimental | Other: EXTRA VIRGIN OLIVE OIL, Other: OLIVE OIL LOW POLYPHENOLAfter a 3-day run-in period avoiding EVOO consumption, participants will consume a daily amount of 0.7 g of OOLP/ kg body weight in addition to their usual diet for 1 month. Then, they will have 4 weeks with their usual diet and another run in period of 3 days before starting the intervention which consists of following their usual diet plus 0.7 g of EVOO / kg body weight daily for one month. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult with Body mass index (BMI) < 30 kg/m2
- Signed informed consent
Key exclusion criteria (10 listed)
- Any chronic disease (e.g. cardiovascular disease, cancer or diabetes)
- Mental disorders (e.g. depression, dementia, autism, etc.)
- Cardiovascular alterations in cholesterol,triglycerides, glucose, etc.
- Current smokers
- Repeated use of antibiotics
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 |
|---|---|---|
| EXTRA VIRGIN OLIVE OILParticipants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked | Other | EXTRA VIRGIN (intervention / control), LOW POLYPHENOL (control/intervention) |
| OLIVE OIL LOW POLYPHENOLParticipants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked | Other | EXTRA VIRGIN (intervention / control), LOW POLYPHENOL (control/intervention) |
Primary outcome
Changes in brain-derived neurotrophic factor (BDNF) after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Serum samples will be analysed for mature BDNF using a Mature BDNF Rapid ELISA kit.
Changes in the gut microbiota after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Fecal samples will be collected by the volunteers using a system for easy self-collection and stabilization of microbial DNA for gut microbiome profiling (OMNIgene - GUT). The extraction of genomic DNA from fecal samples will be carried out utilizing the DNeasy Power Kit. Subsequently, microbial profiling will employ 16 S ribosomal RNA (rRNA) sequencing to investigate microbial communities, with a specific focus on bacterial phylogeny and taxonomy.
Changes in the polyphenols and their metabolites after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Polyphenols and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using high performance liquid chromatography (HPLC) - Linear Trap Quadrupole (LTQ) Orbitrap-MS/MS and HPLC-MS/MS techniques.
Changes in carotenoids and their metabolites after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Carotenoids and their metabolites derived from intestinal gut microbiota will be identified and quantified in human plasma, urine, feces, and saliva samples using high performance liquid chromatography (HPLC) - Linear Trap Quadrupole (LTQ) Orbitrap-MS/MS and HPLC-MS/MS techniques.
Changes in the short-chain fatty acids in plasma and feces samples after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
After acidifying the fecal samples with formic acid, a quantification of short-chain fatty acids will be performed using gas chromatography by direct injection according to previously described methodology (Zhao et al., 2006).
Changes in bile acids in plasma and feces samples after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Bile acids will be assayed using a validated liquid chromatography-mass spectrometry (LC-MS) method
Changes in cerebrovascular function after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Cerebrovascular function will be measured using functional magnetic resonance imaging (FMRI), a non-invasive method for assessing brain activity. FMRI maps blood oxygenation levels in the brain and estimates changes in the blood flow that depends on metabolic function and is correlated with specific brain region activities
17 secondary outcomes
Changes in body weight after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in body mass index (BMI) after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in hip circumference after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in waist circumference after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in body composition after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in blood pressure after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in heart rate after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in lipidic profile after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in liver function after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in glucose after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Assessing variations in inflammatory biomarkers post-intervention for both EVOO treatments and the control group.
Time frame: Baseline and after completed each intervention (1 month)
Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in inflammatory biomarkers after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in nutrients and energy intake after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in quality of the diet after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in physical activity after each intervention with EVOO and the control intervention.
Time frame: Baseline and after completed each intervention (1 month)
Changes in sleep quality after each intervention with EVOO and the control intervention
Time frame: Baseline and after completed each intervention (1 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 Healthy Nutrition
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXTRA VIRGIN OLIVE OIL and OLIVE OIL LOW POLYPHENOL in people with Healthy Nutrition, run by University of Barcelona at 1 site 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 2 inclusion and 10 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 1 site 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. 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 in brain-derived neurotrophic factor (BDNF) after each intervention with EVOO and the control intervention. (time frame: Baseline and after completed each intervention (1 month)). The study lists 7 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.