Tokyo, March 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061055) titled 'Effects of continuous intake of test food on intestinal microbiota and dietary habits' on March 25.

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 exploratorily evaluate the effects of 4-week continuous intake of test food on intestinal microbiota and dietary habits in adults (18 to 64 years old). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake 15g of test food (syrup containing kestose and inulin) daily for 4 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate. 2. Persons who are Japanese aged 18 to 64 years old at the time of consent. 3. Persons who do not have intestinal diseases (including those judged as not needing immediate treatment). Key exclusion criteria - 1. Persons who may develop abdominal pain due to materials containing kestose or inulin. 2. Persons who are currently diagnosed with small or large intestinal diseases (including inflammatory bowel disease (IBD)), or have a history of or scheduled for small or large intestinal resection. 3. Persons who are diagnosed with malignant tumors, or receiving treatment for serious diseases (cranial nerve, heart, kidney, diabetes, or thyroid dysfunction), or have a history of serious diseases such as liver disease (excluding diseases judged by the principal investigator to have no impact on the evaluation of this study, such as treatment for hypertension). 4. Persons who consume a large amount of alcohol (60 g or more per day in terms of alcohol). 5. Persons who are allergic to the test food. 6. Persons who usually consume a large amount of the test food. 7. Persons who regularly use medicines or functional foods (specified health foods, functional foods, and functional nutrition foods) that may affect the intestinal environment. 8. Persons who participated in other studies within one month before the start of the study, or those who plan to participate in other studies after consenting to this study. 9. Persons who are judged as inappropriate by the principal investigator. 10. Persons who are pregnant, breastfeeding, or planning/hoping to become pregnant during the study period. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 20 Day Anticipated trial start date - 2026 Year 03 Month 26 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069860

Disclaimer: Curated by HT Syndication.