Clinical trial NCT05891977: Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults
Official title: Development of Sustainable Tomato Products to Improve the Microbiota-gut-brain Axis: From Farm to Fork to Health (MITOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Cognitive Function
Healthy Lifestyle
Keywords: Carotenoid
Inflammation Mediators
Preventive Medicine
Polyphenols
Tomato
Clinical trial
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in brain-derived neurotrophic factor (BDNF) after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in cognitive function (executive) after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in cognitive function (attention) after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in cognitive function (memory) after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in cerebrovascular function after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in the gut microbiota after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in the polyphenols and carotenoids and their metabolites after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in the short-chain fatty acids in plasma and feces samples after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in bile acids in plasma and feces samples after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
Secondary outcomes:
measure: Changes in Body mass index after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in waist-to-hip ratio with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in anthropometric measurements after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in body composition after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in blood pressure after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in heart rate after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in lipidic profile after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in liver function after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in glucose after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in pro- and anti-inflammatory biomarkers after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in nutrients and energy intake after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in quality of the diet after each intervention with tomato paste and the control intervention.
timeFrame: Baseline
measure: Changes in physical activity after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in sleep quality after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Changes in quality of life after each intervention with tomato paste and the control intervention.
timeFrame: Baseline and after completed each intervention (3 months)
measure: Sensory threshold and organoleptic analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.
Study officials:
affiliation: University of Barcelona
name: Rosa M Lamuela Raventós, PhD
role: PRINCIPAL_INVESTIGATOR
References: