Verification study of Bowel Movement Improvement by Amazake Consumption

UMIN ID: UMIN000036196

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2018/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

190g of Amazake using the lees and rice koji, 1 bottle per day
190g of hot water, 1 cup per day

Outcome(s)

• Primary Outcome: number of bowel movements per day, amount of stools, strength of odor, state of the stool, sensation after defecation per bowel movement.
• Secondary Outcome: number of tablets of the magnesium carbonate which ingested per day

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude criteria: 1) Person who have symptoms other than mild constipation 2) Person who is no history of visits for the past 3 months 3) Person who have some factor that the examining physician can not judge the affect to the study 4) Person who may be allergic to the test food ingredients 5) Person who regularly drink sweet sake (manufacturer is not matter) 6) Person who plan pregnancy, lactation or pregnancy possibility and pregnancy during the study period 7) Person with alcoholism or other mental disorders 8) Person who may change lifestyle during the examination period (night work, long trips, etc.) 9) Person who are planning to take health functional food or supplement food during the test period 10) Person who received treatment with hospitalization within the past 6 months 11) Person who are currently participating in other clinical trials, or person who have not passed three months after participating in other clinical trials 12) Person who the study doctor judged as inappropriate for this study

Related Information

• Primary Sponsor: Morinaga & CO., LTD.
• Source(s) of Monetary Support: Morinaga & CO., LTD.