Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060430) titled 'Elucidation of dietary signal molecules through collection of human gastrointestinal tract contents' on Jan. 21.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kyoto university
Condition:
Condition - healthy adult volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In this study, gastric contents will be collected from humans after ingestion of a model food, and the resulting molecular profiles will be comprehensively analyzed using liquid chromatography-mass spectrometry. This approach enables the direct identification of molecules that are actually generated within the human gastrointestinal tract. Furthermore, by comparing these results with those obtained from in vitro simulated digestion experiments and analyses of gastrointestinal contents from mouse models, a more accurate evaluation and validation of digestive simulations can be achieved.
Basic objectives2 - Pharmacokinetics
Intervention:
Interventions/Control_1 - After oral ingestion of a test meal composed of protein components, upper gastrointestinal endoscopy (EGD) will be performed to collect digested gastric contents.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Participants will be recruited from among the principal investigator, co-investigators, and members affiliated with the Laboratory of Food Physiological Functions, Division of Food Science and Biotechnology, Graduate School of Agriculture, Kyoto University, who voluntarily express their willingness to participate in the study.
Key exclusion criteria - Individuals with diseases under active medical treatment will be excluded. However, individuals whose conditions are well controlled by medication will not be excluded.
Target Size - 3
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 30 Day
Anticipated trial start date - 2026 Year 03 Month 30 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069132
Disclaimer: Curated by HT Syndication.