Effect of Daily Intake of AU-1705 on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Not Applicable

• Conditions: Healthy adults

• Registration Number: JPRN-UMIN000036092
• Lead Sponsor: Hokkaido Information University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Study Completion: 2019-06-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders. 2. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication. 3. Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 7. Subjects with severe anemia. 8. Pre- or post-menopausal women complaining of obvious physical changes. 9. Subjects who are at risk of having allergic reactions to drugs or foods, especially gelatin and/or soybean. 10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect intestinal environment. 11. Subjects who have used as needed or continued to use antibiotics within 4 weeks prior to screening test. 12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 14. Pregnant or lactating women or women who expect to be pregnant during this study. 15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota diversity at 4 weeks after beginning the intake of test food.

Secondary Outcome Measures

Name	Time	Method
Blood BDNF, blood catecholamine, IFN-gamma, fecal mucin, the Japanese version of constipation assessment scale MT version (CAS-MT), self-rating depression scale (SDS), VAS questionnaire.