The effects of test food intake on improving defecation

UMIN ID: UMIN000050375

Registered date:19/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2023/03/10
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of test food A for 4 weeks
Ingestion of test food B for 4 weeks
Ingestion of placebo food for 4 weeks

Outcome(s)

• Primary Outcome: Defecation status(number of defecation, days of defecation, form of feces, amount of feces) The Japanese Version of the Constipation Assessment Scale (CAS-MT)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects with a history of diabetes, liver, kidney, digestive, heart, respiratory diseases, peripheral neuropathy, and other serious illness (2) Subjects with diseases currently being treated (3) Subjects who are allergic to food and drugs (4) Subjects who are continuously treated by taking medicines (including OTC and prescription drugs) (excluding external preparation such as compresses and hair growth agents) (5) Pregnant (including those who may be pregnant) or lactating female subjects (6) Subjects who cannot stop taking healthy foods with intestinal regulating action (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (7) Subjects with consuming too much alcohol or not abstaining from alcohol from the day before the test to the day of the test (8) Subjects who are participating in or will participate in other clinical trials at the start of this study. (9) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Related Information

• Primary Sponsor: Miura Clinic, Medical Corporation Kanonkai
• Source(s) of Monetary Support: Morinaga & Co.,Ltd.