NCT05891977

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

Development of Sustainable Tomato Products to Improve the Microbiota-gut-brain Axis: From Farm to Fork to Health (MITOS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	Intervention A - Tomato paste	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
OTHER	Intervention B - Control	Participants will consume the regular diet plus consumption of low to moderate tomato or tomato-based products and lycopene containing foods

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-12-04
• Completion: 2024-12-04
• First posted: 2023-06-07
• Last updated: 2025-06-25

Locations

1 site across 1 country: Spain