Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058389) titled 'Evaluation of the effect of test food intake on the intestinal environment in healthy adults' on July 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - BIOSIS Lab. Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of beverages containing oligosaccharides and inulin on the intestinal environment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Take one serving of the test food daily

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate 2.Persons who are male or female and 18 years old or more at the time of obtaining consent 3.Persons who do not have intestinal diseases (including those who are judged not to require immediate treatment) Key exclusion criteria - 1.Persons who may experience stomach pain when eating foods containing oligosaccharides 2.Persons who have been diagnosed with a gastrointestinal disease (gastrointestinal disease accompanied by gastrointestinal inflammation, such as inflammatory bowel disease (IBD)), those who have previously undergone gastrointestinal surgery, and those who will require gastrointestinal surgery in the future 3.Persons who regularly use materials containing oligosaccharides (3 days or more per week) or have regularly used them within one month prior to the pre-test 4.Persons who have been diagnosed with malignant tumors, are currently receiving treatment for cranial nerve disorders, heart disease, kidney disease, diabetes, or thyroid dysfunction, or have a history of other serious illnesses, excluding illnesses like hypertension, which principal investigator determined will not affect the evaluation of the research 5.Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey) 6.Persons who are at risk of developing allergies related to the test foods 7.Persons who are judged unsuitable as research subjects based on their responses to a background survey 8.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 9.Persons who are judged to be ineligible by the principal investigator Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 04 Day Date of IRB - 2025 Year 07 Month 04 Day Anticipated trial start date - 2025 Year 07 Month 07 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066756

Disclaimer: Curated by HT Syndication.