Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level

UMIN ID: UMIN000039159

Registered date:18/01/2020

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Diabetes mellitus
• Date of first enrollment: 2020/01/18
• Target sample size: 2
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A sucrose tolerance test is conducted at intervals of 3 days or more under physiological saline intake(single ingestion 10mL) and lactic acid bacteria #Ef-1 strain intake(heat-sterilized bacteria at 80 degree centigrade, single ingestion 10mL).

Outcome(s)

• Primary Outcome: Postprandial blood glucose levels Area under the curve(AUC) of postprandial blood glucose levels
• Secondary Outcome: Postprandial insulin levels

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects using medical products due to any illness 2) Subjects with a current or past medical history that may affect the test results 3) Subjects who could cause allergic symptoms related to the test products 4) Subjects who regularly use health foods or supplements that may affect glucose metabolism 5) Subjects who have used any drugs within one week prior to the current clinical trial 6) Subjects who have participated in other clinical trials within the last four weeks prior to the current clinical trial 7) Subjects who are judged by the investigator to be inappropriate for participation in this study

Related Information

• Primary Sponsor: Yotsuya Medical Cube
• Secondary Sponsor: Pharmaspur Inc.
• Source(s) of Monetary Support: Genome Pharmaceuticals Institute Co.,Ltd.