Exploratory study on the intestinal regulating effects of test food intake using responder determinatio

Not Applicable

• Conditions: Healthy male/female adults

• Registration Number: JPRN-UMIN000052376
• Lead Sponsor: Metagen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-02
• Last Update Posted: 17 October 2023
• Study Completion: 2024-03-18

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Subjects who are taking food for specified health use, foods with functional claims, health foods, or supplements that may affect the intestinal environment and have been unable to discontinue them since the time of obtaining consent. (2)Subjects who have a plan or who have taken medication within a month before the pre-test start, which would affect the intestinal environment. (3)Subjects who had undergone appendectomy. (4)Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent. (5)Subjects who take excessive alcohol. (6)Smoker (7)Subjects having an irregular life rhythm with irregular shift work or midnight. (8)Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial. (9)Subjects whose roomer is planning to join this trial. (10)Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (11)Pregnant, possibly pregnant, or lactating women. (12)Subjects who are allergic to medicines and test foods. Subjects who donated their blood components, and/or whole blood as below (13)all subjects: 200 mL within a month (14)males: 400 mL within the last 3 months (15)females: 400 mL within the last 4 months to this trial. Subjects whose collected blood volume within the last 12 months would reach to the following criteria after adding the blood collection in this study; (16)males: 1,200 mL (17) females: 800 mL (18) Others who have been determined ineligible by the principal/sub investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Defecation frequency

Secondary Outcome Measures

Name	Time	Method
1. Defecation status 2. Abdominal symptoms at times other than defecation 3. CAS-MT 4. Gut microbiota 5. Gut metabolites