A confirmation study of bowel control effect by consumption of the test food

UMIN ID: UMIN000039591

Registered date:28/02/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2020/02/28
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake one capsule of the test food a day for two weeks
Intake one capsule of the control food a day for two weeks

Outcome(s)

• Primary Outcome: Defecation status (defecation frequency, defecation days, Bristol Stool Sclae)
• Secondary Outcome: *Defecation status (smell of stool, color of stool, volume of stool, exhilaration by defecation, abdominal symptoms) * Analysis of organic acids content in stool * Stool properties (pH of stool, water content of stool) * Analysis of stool ammonia * Intestinal microbiota (Analysis by sequencing of amplicons) * Incidence of adverse events and of side effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects who constantly eat seaweeds like simmered laver in sweetened soy sauce etc., or subjects who can't restrict eat them during test period. 2) Subjects who are given continuous treatment by taking medicines. 3) Subjects who intaking Food for Specified Health Uses (FOSHU), food with function claims and/or health food, those having possibility of defecation improvement or soft stool improvement, more than three days a week. 4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 6) Subjects who excessive alcohol intake. 7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 8) Subjects who have previous medical history of drug and/or food allergy. 9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 11) Males who donated over 400mL blood and/or blood components within the last three months to the current study. 12) Females who donated over 400mL blood and/or blood components within the last four months to the current study. 13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 15) Others who have been determined ineligible by principal investigator or sub-investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: KONAN CHEMICAL MANUFACTURING CO., LTD.