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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2024-12-04

Brief Summary

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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.

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Detailed Description

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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

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Microbiota Cognitive Function Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group AB (intervention / control)

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.

Group Type EXPERIMENTAL

Intervention A - Tomato paste

Intervention Type 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

Intervention B - Control

Intervention Type OTHER

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

Group BA (control / intervention)

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.

Group Type EXPERIMENTAL

Intervention A - Tomato paste

Intervention Type 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

Intervention B - Control

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes