Tokyo, July 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062144) titled 'A study on the Effects of Continued Consumption of the Test Food on the Gut Microbiota' on July 14.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co. Ltd.

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

Objective: Narrative objectives1 - To evaluate the effects of 8 weeks of continuous consumption of the test food on the gut microbiota in men and women aged 20 to under 65 years. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Take 3 sachets of the test food per day (15 mL per sachet).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1.Aged 20 years or older and under 65 at the time of informed consent 2.Japanese men or women 3.Able to enter electronic diaries via smartphone or PC 4.Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent Key exclusion criteria - 1.Currently receiving outpatient treatment or medication (including Kampo) for any disease (as-needed use permitted) 2.Under dietary or exercise therapy supervised by a physician 3.Current or past history of serious disease 4.Used medications affecting the study (e.g., antibiotics, probiotics, laxatives) within 1 month before consent, or plans to use during the study 5.Planned endoscopy, barium examination, H. pylori eradication, or tooth extraction during the study 6.History of gastrointestinal diseases or surgeries affecting digestion/absorption (excluding appendectomy or hemorrhoid surgery) 7.Currently taking quasi-drugs, specified health foods, health foods, or supplements 3 or more days per week (those taking =40g pure alcohol/day) 10.Habitual excessive smoking (>=21 cigarettes/day) 11.Shift workers with night shifts 12.Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study 13.Plans for overseas travel during the study 14.Pregnant, breastfeeding, or planning pregnancy during the study 15.Participated in another clinical study within 1 month before consent, currently participating, or planning to participate during the study 16.Deemed unsuitable for participation by the principal investigator Target Size - 5

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 16 Day Anticipated trial start date - 2026 Year 09 Month 07 Day Last follow-up date - 2026 Year 11 Month 02 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071065

Disclaimer: Curated by HT Syndication.