Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059357) titled 'Verification study on improvement of bowel movement by 2-week intake of test food' on June 30.

Study Type: Interventional

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

Primary Sponsor: Institute - Morinaga & Co., Ltd.

Condition: Condition - N/A(healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the effect of ingestion of the test food for 2 weeks on improving stool frequency. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral ingestion of a test food for 2 weeks Interventions/Control_2 - Oral ingestion of a placebo food for 2 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1)Healthy males and females aged 20 to 64 years (2)Individuals who have a tendency towards constipation (3)Individuals who can attend on the designated day (4)Individuals whose written informed consent has been obtained Key exclusion criteria - (1)Individuals with a history of diabetes, liver, kidney, gastrointestinal, heart, respiratory, vascular, or other serious diseases (2)Individuals currently under treatment for diseases, especially internal or gastrointestinal diseases (3)Individuals with food or drug allergies (4)Individuals who are continuously receiving treatment with oral drugs (including OTC and prescription drugs) (5)Individuals who are or are possibly pregnant, or lactating (6)Individuals who have had a history of abdominal surgery within the past 5 years (7)Individuals who have been diagnosed with functional constipation, etc. at a medical institution and are under treatment, and patients who are aware of irritable bowel syndrome (8)Individuals who defecate once or twice a week (9)Individuals who do not like a test food (10)Individuals who are current smokers (11)Individuals who are currently or in the past 3 months habitually taking health foods (Including foods for specified health use and foods with functional claims) or designated quasi-drugs that are claimed to regulate intestinal function, or who plan to take them during the study (12)Individuals who are currently or in the past 3 months habitually taking Chinese medicine or supplements with intestinal-regulating ingredients (e.g., senna, aloe), or plan to do so during the study (13)Individuals who may change their lifestyle during the study period (Night shift, long travel, etc.) (14)Individuals who regularly consume excessive amounts of alcohol (For example, drinkers who consume an average of > 60 g/day of pure alcohol per week: 3 bottles(500ml) of beer) or who cannot abstain from alcohol from the day before to the day of the study (15)Obtained consent to participate in the study. Individuals who are participating in or planning to participate in another clinical study within 1 month (16)Other individuals judged by the investigator or the trustee to be inappropriate subjects for the study Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 20 Day Date of IRB - 2025 Year 08 Month 23 Day Anticipated trial start date - 2025 Year 10 Month 21 Day Last follow-up date - 2025 Year 11 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067553

Disclaimer: Curated by HT Syndication.