Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059060) titled 'Exploratory Study to Evaluate the Impact of Prebiotic Intake on the Gut Microbiota and Health Status' on Sept. 11.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Meiji Holdings Co., Ltd.

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

Objective: Narrative objectives1 - To examine the effect on gut microbiota and health status by administration of oligosaccharide for 4 weeks Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral ingestion of oligosaccharide for 4 weeks Interventions/Control_2 - Oral ingestion of placebo for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Healthy adults aged 20-64 years at the time of consent 2. Persons who, after adequate explanation of the study purpose and procedures, have the capacity to consent, understand the information, and voluntarily provide informed consent to participate Key exclusion criteria - 1. History of gastric or lower gastrointestinal surgery (excluding hemorrhoid surgery and polypectomy) 2. Current serious disease affecting the liver, kidneys, heart, lungs, or gastrointestinal tract, or other organ dysfunction; diabetes mellitus; rheumatoid arthritis; neurological or psychiatric disorders; sleep disorders; chronic fatigue syndrome; or any other serious or progressive disease 3. Underwent gastric X-ray barium examination or bowel cleansing (in a clinic or at home) within 1 month prior to screening, or plans to undergo these during the study 4. Took any antibiotic at least once within 1 month prior to screening, or is taking at least weekly-or plans to take during the study-any medication that may affect the study (e.g., proton-pump inhibitors, antidiabetic drugs such as metformin, laxatives such as magnesium oxide, or ursodeoxycholic acid) 5. Current smoker within 1 month prior to consent 6. Plans for overseas travel, or trips/business travel longer than 1 week, from the date of consent until completion of the 4-week post-consent assessment 7. Average daily alcohol consumption exceeds sixty grams of ethanol 8. Irregular lifestyle due to shift or night work 9. Performing resistance training more than 4 times per week (e.g., weight training with barbells, dumbbells, or machines) 10. Presence of food allergies 11. Pregnant, lactating, or possibly pregnant 12. Any other condition judged by the principal or sub-investigator to be inappropriate for study participation Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 29 Day Anticipated trial start date - 2025 Year 09 Month 11 Day Last follow-up date - 2025 Year 11 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067555

Disclaimer: Curated by HT Syndication.