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

Last updated: March 31, 2025
Sponsor: University of Barcelona
Overall Status: Completed

Phase

N/A

Condition

Brain Function

Treatment

Intervention A - Tomato paste

Intervention B - Control

Clinical Study ID

NCT05891977
PID2020-114022RB-I00
  • Ages 40-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy adult subjects with BMI < 30 kg/m2

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Intervention A - Tomato paste
Phase:
Study Start date:
October 25, 2023
Estimated Completion Date:
December 04, 2024

Study 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.

Connect with a study center

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

    Barcelona, 08028
    Spain

    Site Not Available

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