Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.

UMIN ID: UMIN000045463

Registered date:17/09/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult male
• Date of first enrollment: 2021/09/21
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1 grains of the test product daily oral intake for 4 weeks.
2 grains of the test product daily oral intake for 4 weeks.
4 grains of the test product daily oral intake for 4 weeks.

Outcome(s)

• Primary Outcome: Area under the curve of blood glucose level (AUC), Area under the rising curve of blood glucose level (IAUC) Evaluate at points of 4 week of intake period.
• Secondary Outcome: Area under the curve of insulin level (AUC), Area under the rising curve of insulin level (IAUC), insulinogenic index, Fasting blood glucose level, HbA1c Evaluate at points of 4 week of intake period.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male
• Exclude criteria: (1) Subjects who regularly use functional foods or supplements containing omega-3 fatty acids such as DHA, EPA, and Alpha-linolenic acid. (2) Subjects who regularly use functional foods or supplements containing algae (e.g., aurantiochytrium, euglena, spirulina, greenbug, etc.) (3) Subjects who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect blood glucose metabolism. (4) Subjects who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease). (5) Subjects who have a disease under treatment, or a serious or pre-existing disease that requires medication. (6) Subjects with diseases that may cause diabetes or abnormalities in glucose metabolism, and subjects with a history of such diseases (e.g., pancreatic diseases, endocrine disorders, gastrectomy) (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination before intake. (9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires. (11) Subjects who have donated of blood within 1 month before beginning pre-inspection. (12) Subjects who are judged as unsuitable for the study by the investigator for other reason.

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: Sea Act Co., LTD