Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891977
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-05-17
Brief Title:
Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults
Sponsor:
University of Barcelona
Organization:
University of Barcelona
Study Overview
Official Title:
Development of Sustainable Tomato Products to Improve the Microbiota-gut-brain Axis From Farm to Fork to Health MITOS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITOS
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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None