Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults

NCT05891977 | Completed DMC

• 1 other identifier: PID2020-114022RB-I00
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Microbiota; Cognitive Function; Healthy Lifestyle

Keywords

Carotenoid; Inflammation Mediators; Preventive Medicine; Polyphenols; Tomato; Clinical trial

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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

  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.

  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.

  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).

  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

  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.

  Baseline and after completed each intervention (3 months)

• Changes in waist-to-hip ratio with tomato paste and the control intervention.

  Baseline and after completed each intervention (3 months)

• Changes in anthropometric measurements after each intervention with tomato paste and the control intervention.

  Baseline and after completed each intervention (3 months)

• Changes in body composition after each intervention with tomato paste and the control intervention.

  Baseline and after completed each intervention (3 months)

• Changes in blood pressure after each intervention with tomato paste and the control intervention.

  Baseline and after completed each intervention (3 months)

Study Arms (2)

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.

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.

Other: Intervention A - Tomato paste; Other: Intervention B - Control

Interventions

Intervention A - Tomato paste OTHER

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

Group AB (intervention / control); Group BA (control / intervention)

Intervention B - Control OTHER

Participants will consume the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods

Group AB (intervention / control); Group BA (control / intervention)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subjects with BMI \< 30 kg/m2
• Signed informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.

Barcelona, Barcelona, 08028, Spain

Location

Study Officials

• Rosa M Lamuela Raventós, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 7, 2023
• Study Start: October 25, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)