Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058588) titled 'A Study on the Effects of the Test Food on Intestinal Regulation -A Randomized, Double-blind, Placebo-controlled Crossover Study-' on July 28.

Study Type: Interventional

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

Primary Sponsor: Institute - KSO Corporation

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

Objective: Narrative objectives1 - To examine the effects of test food on bowel movements and intestinal environment for four weeks. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consumption of the test food (1 pack a day, 4 weeks) -> Washout period (4 weeks) -> Consumption of the placebo food (1 pack a day, 4 weeks) Interventions/Control_2 - Consumption of the placebo food (1 pack a day, 4 weeks) -> Washout period (4 weeks) -> Consumption of the test food (1 pack a day, 4 weeks)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy subjects aged of 20-64 years 2) Subjects who defecate 3-5 times a week at the point of screening test 3) Subjects who have received sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate on good understanding, and have agreed to participate in the study in writing Key exclusion criteria - 1) Subjects who have a history, current history or undergoing medical treatment of serious kidney disease, heart disease, respiratory disease, endocrine disease or diabetes 2) Subjects who have a chronic disease and regularly use medications 3) Subjects who diagnosed with chronic constipation 4) Subjects who have a digestive disease that affects digestion and absorption or defection, or a history of surgery (excluding appendicitis) 5) Subjects who have a history or current medical history of drug dependence or alcoholism 6) Subjects who plan to take medicines that affect the intestinal environment from the time of research application until the end of the study period 7) Subjects who are taking antibiotics or antibacterial agents, or who have taken them from the time of research application 8) Subjects who have consumed health foods or supplements that are known to improve constipation or affect the intestinal environment, 3 times a week or more at the time of the screening test 9) Subjects who have reported that they are allergic to the ingredient in test foods 10) Subjects who have a habit of drinking excessively 11) Subjects who have a habit of smoking excessively 12) Subjects who are pregnant, planning to become pregnant during this study or lactating 13) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month of informed consent 14) Subjects who plan to change their existing lifestyle, eating habits or living environment during the study period 15) Subjects who had one or less meals per day at least once a week during the month prior to application for the study 16) Subjects who have donated more than 200 mL of blood and/or component blood within one month or more than 400 mL within three months of consent in this study 17) Subjects who are restricting carbohydrates or dieting 18) Subjects who are judged as ineligible to participate in this study by the principal investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 30 Day Date of IRB - 2025 Year 06 Month 05 Day Anticipated trial start date - 2025 Year 07 Month 29 Day Last follow-up date - 2025 Year 12 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066943

Disclaimer: Curated by HT Syndication.