Verification of the effects of test foods on the intestinal environment

UMIN ID: UMIN000047742

Registered date:12/05/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2022/05/13
• Target sample size: 20
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional
• Intervention(s): Oral intake of test food (4 weeks)

Outcome(s)

• Primary Outcome: Bifidobacteria, good bacteria
• Secondary Outcome: Other intestinal environment data

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male
• Exclude criteria: 1) Those with a history or current condition (disease) of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease 2) Persons who are currently undergoing treatment for a serious illness. 3) Persons with food allergies or those who are at risk of developing allergies related to the tested food 4) Who are regularly using medicines or quasi-drugs that may affect the test items. 5) Persons who regularly use health foods (food for specified health use, nutritional supplements, functional foods, supplements, etc.) that may affect the test items. 6) Persons who are unable to discontinue the intake of pharmaceuticals (excluding intravenous medication), quasi-drugs, or health foods (food for specified health uses, nutritional supplements, foods with functional claims, supplements, etc.) from the time of obtaining consent to the completion of the study. 7) Persons who are unable to restrict or discontinue foods (including alcohol) that affect the data 8) Who are currently participating in a clinical trial or have participated in another clinical trial within the past 3 months from the date of obtaining consent 9) Who plan to participate in other clinical trials during the study period 10) Who are unable to maintain their daily lifestyle. 11) Who have difficulty consuming the study food as directed 12) Other subjects who are judged by the investigator to be unsuitable for the study.

Related Information

• Primary Sponsor: APO PLUS STATION CO., LTD.
• Source(s) of Monetary Support: ANGFA Co.,Ltd.