MicrobiotaMITOSNCT05891977
Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults
A study testing Intervention A - Tomato paste in people with Microbiota and Cognitive Function, run by University of Barcelona at 1 site in Spain.
Trial summary
Tomatoes and tomato-based products could play an important role in modulating microbiota-gut-brain axis (MGBA) interactions due to their high content of fiber and phytochemicals. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Cognitive Function, Healthy Lifestyle
- What is being tested?
- Intervention A - Tomato paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2023to 4 Dec 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects with BMI < 30 kg/m2
- Signed informed consent
Who cannot join
- Participants with tomato allergy or intolerance
- Cardiovascular disease (cancer or diabetes)
- Mental disorders (e.g. depression, dementia, autism, etc.)
- Cardiovascular alterations in triglycerides or glucose
- Participants with body mass index (BMI) > 30 kg/m2
- Current smokers
Show all 10Show fewer
- Frequent use of corticoids, nonsteroidal anti-inflammatory drugs
- 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 or lactating 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 Sustainable Tomato Products to Improve the Microbiota-gut-brain Axis: From Farm to Fork to Health (MITOS)
Tomatoes and tomato-based products could play an important role in modulating microbiota-gut-brain axis (MGBA) interactions due to their high content of fiber and phytochemicals. Phytochemical metabolites derived from the consumption of tomato-based products can act directly as neurotransmitters in the central nervous system, crossing the blood-brain barrier, or indirectly by modulating the MGBA. These metabolites can thus alter gut bacterial composition and brain biochemistry. Therefore, researchers propose a new interventional study to assess the impact of daily tomato consumption in the organism, and to evaluate the effect on the MGBA. The final aim of this study is to spread a message of the health benefits of tomato consumption for the general population.
Read the detailed description
To evaluate the possible changes in microbiota and cognitive skills after consumption of tomato paste in a crossover randomized controlled study. Fifty healthy adults subjects (aged 40-55 years and consisting of 50% males and 50% females to assess possible sex-based responses) will be included. Participants will sign the informed consent and carry out a washout period without consuming any tomatoes or tomato-based products during 1 week. Participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (experimental intervention), and the normal diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (control intervention) during 3 months. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hours urine, feces, and saliva) will be obtained at baseline and the end of each arm of the trial.
- Conditions
- Microbiota, Cognitive Function, Healthy Lifestyle
- Being tested
- Intervention A - Tomato paste, Intervention B - Control
- Keywords
- Carotenoid, Inflammation Mediators, Preventive Medicine, Polyphenols, Tomato, Clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A - Tomato pasteOther
Participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods
Intervention B - ControlOther
Participants will consume the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods
| Study group | Role | What they receive |
|---|---|---|
| Group AB (intervention / control) | Experimental | After a 1-week washout period avoiding consumption of tomato, tomato-based products and other food sources of lycopene (watermelon, papaya, grapefruit and lycopene supplements), participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during 3 months (intervention). Then they will return to their regular dietary pattern during 3 weeks. At the beginning of the first 4 month, participants will be encouraged to move into the second phase (control), before a 1-week washout period. The second phase or control consists in following their regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during the next 3 months. Receives: Other: Intervention A - Tomato paste; Other: Intervention B - Control |
| Group BA (control / intervention) | Experimental | After a 1-week washout period avoiding consumption of tomato, tomato-based products and other food sources of lycopene (watermelon, papaya, grapefruit, and lycopene supplements), participants will start the control intervention which consists of following their regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during 3 months (control). Then they will return to their regular diet during 3 weeks. At the beginning of the first 4 month, participants will be encouraged to move into the second phase (intervention), before a 1-week washout period. The intervention consist in consuming a daily amount of 0.5 g of tomato paste / kg of body weight diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during the next 3 months. Receives: Other: Intervention A - Tomato paste; Other: Intervention B - Control |
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 tomato paste 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 (3 months)
Changes in cognitive function (executive) after each intervention with tomato paste and the control intervention.
The Wisconsin Sorting Cards Test (WSCT) will assess strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behaviour towards achieving a goal and modulating impulsive responding.
Measured: Baseline and after completed each intervention (3 months)
Changes in cognitive function (attention) after each intervention with tomato paste and the control intervention.
The d2 Test will meausure selective and sustained attention and visual scanning speed. Processing speed, rule compliance, and quality of performance will be assess in participants.
Measured: Baseline and after completed each intervention (3 months)
Changes in cognitive function (memory) after each intervention with tomato paste and the control intervention.
The face-name associative memory exam (FNAME) will assess associative memory function.Participants will be asked to remember a set of faces and the names they are paired with. After a 5-25 minute delay, participants will recall which of the faces and names they saw earlier.
Measured: Baseline and after completed each intervention (3 months)
Changes in cerebrovascular function after each intervention with tomato paste 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 (3 months)
Changes in the gut microbiota after each intervention with tomato paste 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 genomic DNA will be extracted from fecal samples using the DNeasy PowerSoil Kit. Then, microbial profiling using 16S ribosomal RNA (rRNA) sequencing will be used to study microbial communities, specially bacterial phylogeny and taxonomy.
Measured: Baseline and after completed each intervention (3 months)
Changes in the polyphenols and carotenoids and their metabolites after each intervention with tomato paste and the control intervention.
Carotenoids and 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-LTQ-Orbitrap-MS/MS and HPLC-MS/MS techniques.
Measured: Baseline and after completed each intervention (3 months)
Changes in the short-chain fatty acids in plasma and feces samples after each intervention with tomato paste 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 (3 months)
Changes in bile acids in plasma and feces samples after each intervention with tomato paste 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 (3 months)
Secondary outcomes (16)
Changes in Body mass index after each intervention with tomato paste and the control intervention.
Body mass index (kg/m^2) will be calculated after measuring weight (kg) and height (meters).
Measured: Baseline and after completed each intervention (3 months)
Changes in waist-to-hip ratio with tomato paste and the control intervention.
Waist and hip circumferences (cm) will be measured in triplicate and then combined to report waist-to-hip ratio.
Measured: Baseline and after completed each intervention (3 months)
Changes in anthropometric measurements after each intervention with tomato paste and the control intervention.
Body mass index (kg/m^2) will be calculated after measure weight (kg) and height (meters). To evaluate waist-to-hip ratio, waist and hip circumferences (cm) will be measured in triplicate.
Measured: Baseline and after completed each intervention (3 months)
Changes in body composition after each intervention with tomato paste and the control intervention.
Body fat percentage will be measured using a bioelectrical impedance analysis monitor.
Measured: Baseline and after completed each intervention (3 months)
Changes in blood pressure after each intervention with tomato paste 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 (3 months)
Changes in heart rate after each intervention with tomato paste and the control intervention.
Heart rate (bpm) will be measured with an automatic monitor in triplicate.
Measured: Baseline and after completed each intervention (3 months)
Changes in lipidic profile after each intervention with tomato paste 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 (3 months)
Changes in liver function after each intervention with tomato paste 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 (3 months)
Changes in glucose after each intervention with tomato paste and the control intervention.
Glucose (mg/dL) will be measured by molecular absorption spectrometry.
Measured: Baseline and after completed each intervention (3 months)
Changes in pro- and anti-inflammatory biomarkers after each intervention with tomato paste and the control intervention.
Cytokines (pg/mL), tumor necrosis factor α (TNF-α) (pg/mL) and C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.
Measured: Baseline and after completed each intervention (3 months)
Changes in nutrients and energy intake after each intervention with tomato paste and the control intervention.
A 7-day food recall will be used. The data will be analyzed using a software called Programa de Càlcul Nutricional Professional (PCN Pro).
Measured: Baseline and after completed each intervention (3 months)
Changes in quality of the diet after each intervention with tomato paste and the control intervention.
Participants will fill the validated questionnaire measuring adherence to the Mediterranean diet.
Measured: Baseline
Changes in physical activity after each intervention with tomato paste and the control intervention.
Physical activity will be assessed with the ActiGraph® wGT3X-BT accelerometer.
Measured: Baseline and after completed each intervention (3 months)
Changes in sleep quality after each intervention with tomato paste and the control intervention.
Sleep quality will be assessed with the ActiGraph® wGT3X-BT accelerometer.
Measured: Baseline and after completed each intervention (3 months)
Changes in quality of life after each intervention with tomato paste and the control intervention.
Quality of life will be assessed with the WHOQOL-BREF.
Measured: Baseline and after completed each intervention (3 months)
Sensory threshold and organoleptic analysis
The recognition threshold of the five basic tastes will be determined through a classical sensory analysis test, employing a battery of solutions containing the molecules of interest. This test will include an organoleptic analysis of tomato paste to evaluate its aroma, taste (including acidity, sweetness, saltiness, umami), and hedonic sensation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start25 Oct 2023
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies 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
- Intervention A: Habitual diet + consumption of low to moderate tomato or tomato products and other food sources of lycopene + 0.5 g of tomato paste / kg of body weight (experimental intervention) for 3 months. Intervention B: Habitual diet + consumption of low to moderate tomato or tomato products and other food sources of lycopene (control) for 3 months.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa M Lamuela-Raventós, University of Barcelona
- Investigators
- Rosa M Lamuela Raventós, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891977
- Sponsor's protocol ID
- PID2020-114022RB-I00
- Acronym
- MITOS
- Status last verified
- Feb 2025
- First submitted
- 17 May 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Solis R, Donat-Vargas C, Ramirez-Carrasco P, Gutierrez-Romero RM, Perez M, Castellvi M, Bosch B, Arancibia-Riveros C, Hinojosa-Moscoso A, Laredo C, Munoz-Moreno E, Ruiz-Leon AM, Casas R, Estruch R, Vallverdu-Queralt A, Corrado M, Lamuela-Raventos RM. Tomato Intake Improves Cognitive Performance and Modulates Functional Brain Networks in Healthy Adults: A Randomized Crossover Clinical Trial. Antioxidants (Basel). 2026 May 19;15(5):644. doi: 10.3390/antiox15050644.
PubMed 42193265
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Sustainable Tomato Products to Improve the Microbiota-gut-brain Axis: From Farm to Fork to Health (MITOS)
- ClinicalTrials.gov ID
- NCT05891977
- Acronym / sponsor ID
- MITOS / PID2020-114022RB-I00
- Conditions
- Microbiota, Cognitive Function, Healthy Lifestyle
- Keywords
- Carotenoid, Inflammation Mediators, Preventive Medicine, Polyphenols, Tomato, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 7 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.
Tomatoes and tomato-based products could play an important role in modulating microbiota-gut-brain axis (MGBA) interactions due to their high content of fiber and phytochemicals. Phytochemical metabolites derived from the consumption of tomato-based products can act directly as neurotransmitters in the central nervous system, crossing the blood-brain barrier, or indirectly by modulating the MGBA. These metabolites can thus alter gut bacterial composition and brain biochemistry. Therefore, researchers propose a new interventional study to assess the impact of daily tomato consumption in the organism, and to evaluate the effect on the MGBA. The final aim of this study is to spread a message of the health benefits of tomato consumption for the general population.
Detailed description
To evaluate the possible changes in microbiota and cognitive skills after consumption of tomato paste in a crossover randomized controlled study. Fifty healthy adults subjects (aged 40-55 years and consisting of 50% males and 50% females to assess possible sex-based responses) will be included. Participants will sign the informed consent and carry out a washout period without consuming any tomatoes or tomato-based products during 1 week. Participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (experimental intervention), and the normal diet plus consumption of low to moderate tomato or tomato-based products and other sources of lycopene (control intervention) during 3 months. Biological samples (plasma, peripheral blood mononuclear cells, serum, 24-hours urine, feces, and saliva) will be obtained at baseline and the end of each arm of the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention A: Habitual diet + consumption of low to moderate tomato or tomato products and other food sources of lycopene + 0.5 g of tomato paste / kg of body weight (experimental intervention) for 3 months. Intervention B: Habitual diet + consumption of low to moderate tomato or tomato products and other food sources of lycopene (control) for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Group AB (intervention / control) | Experimental | Other: Intervention A - Tomato paste, Other: Intervention B - ControlAfter a 1-week washout period avoiding consumption of tomato, tomato-based products and other food sources of lycopene (watermelon, papaya, grapefruit and lycopene supplements), participants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during 3 months (intervention). Then they will return to their regular dietary pattern during 3 weeks. At the beginning of the first 4 month, participants will be encouraged to move into the second phase (control), before a 1-week washout period. The second phase or control consists in following their regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during the next 3 months. |
| Group BA (control / intervention) | Experimental | Other: Intervention A - Tomato paste, Other: Intervention B - ControlAfter a 1-week washout period avoiding consumption of tomato, tomato-based products and other food sources of lycopene (watermelon, papaya, grapefruit, and lycopene supplements), participants will start the control intervention which consists of following their regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during 3 months (control). Then they will return to their regular diet during 3 weeks. At the beginning of the first 4 month, participants will be encouraged to move into the second phase (intervention), before a 1-week washout period. The intervention consist in consuming a daily amount of 0.5 g of tomato paste / kg of body weight diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods during the next 3 months. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult subjects with BMI < 30 kg/m2
- Signed informed consent
Key exclusion criteria (10 listed)
- Participants with tomato allergy or intolerance
- Cardiovascular disease (cancer or diabetes)
- Mental disorders (e.g. depression, dementia, autism, etc.)
- Cardiovascular alterations in triglycerides or glucose
- Participants with body mass index (BMI) > 30 kg/m2
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 |
|---|---|---|
| Intervention A - Tomato pasteParticipants will consume a daily amount of 0.5 g of tomato paste / kg of body weight following the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods | Other | Group AB (intervention / control), Group BA (control / intervention) |
| Intervention B - ControlParticipants will consume the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods | Other | Group AB (intervention / control), Group BA (control / intervention) |
Primary outcome
Changes in brain-derived neurotrophic factor (BDNF) after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Serum samples will be analysed for mature BDNF using a Mature BDNF Rapid ELISA kit.
Changes in cognitive function (executive) after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
The Wisconsin Sorting Cards Test (WSCT) will assess strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behaviour towards achieving a goal and modulating impulsive responding.
Changes in cognitive function (attention) after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
The d2 Test will meausure selective and sustained attention and visual scanning speed. Processing speed, rule compliance, and quality of performance will be assess in participants.
Changes in cognitive function (memory) after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
The face-name associative memory exam (FNAME) will assess associative memory function.Participants will be asked to remember a set of faces and the names they are paired with. After a 5-25 minute delay, participants will recall which of the faces and names they saw earlier.
Changes in cerebrovascular function after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
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
Changes in the gut microbiota after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
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 genomic DNA will be extracted from fecal samples using the DNeasy PowerSoil Kit. Then, microbial profiling using 16S ribosomal RNA (rRNA) sequencing will be used to study microbial communities, specially bacterial phylogeny and taxonomy.
Changes in the polyphenols and carotenoids and their metabolites after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Carotenoids and 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-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 tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
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 tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Bile acids will be assayed using a validated liquid chromatography-mass spectrometry (LC-MS) method
16 secondary outcomes
Changes in Body mass index after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in waist-to-hip ratio with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in anthropometric measurements after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in body composition after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in blood pressure after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in heart rate after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in lipidic profile after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in liver function after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in glucose after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in pro- and anti-inflammatory biomarkers after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in nutrients and energy intake after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in quality of the diet after each intervention with tomato paste and the control intervention.
Time frame: Baseline
Changes in physical activity after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in sleep quality after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Changes in quality of life after each intervention with tomato paste and the control intervention.
Time frame: Baseline and after completed each intervention (3 months)
Sensory threshold and organoleptic analysis
Time frame: Baseline
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 25 Jun 2025.
- Derived from this study: PubMed 42193265Lopez-Solis R, Donat-Vargas C, Ramirez-Carrasco P, Gutierrez-Romero RM, Perez M, Castellvi M, Bosch B, Arancibia-Riveros C, Hinojosa-Moscoso A, Laredo C, Munoz-Moreno E, Ruiz-Leon AM, Casas R, Estruch R, Vallverdu-Queralt A, Corrado M, Lamuela-Raventos RM. Tomato Intake Improves Cognitive Performance and Modulates Functional Brain Networks in Healthy Adults: A Randomized Crossover Clinical Trial. Antioxidants (Basel). 2026 May 19;15(5):644. doi: 10.3390/antiox15050644.
- Individual participant dataSharing planned: No
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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.
Rosa M Lamuela Raventós, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention A - Tomato paste in people with Microbiota and Cognitive Function, 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 25 Jun 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 tomato paste and the control intervention. (time frame: Baseline and after completed each intervention (3 months)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891977, which also lists 1 linked publication.
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 25 Jun 2025.