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

University of Barcelona

Status: Completed

Conditions: Cognitive Function; Healthy Lifestyle; Microbiota

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05891977

PID2020-114022RB-I00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Group AB (intervention / control)

Experimental group

Description:

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.

Treatment:

Other: Intervention A - Tomato paste

Other: Intervention B - Control

Group BA (control / intervention)

Experimental group

Description:

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.

Treatment:

Other: Intervention A - Tomato paste

Other: Intervention B - Control