Healthy adult
Conditions
Interventions
Intake of test food (single ingestion) - washing out (about 1 week) - intake of placebo (single ingestion)
Intake of placebo (single ingestion) - washing out (about 1 week) - intake of test food (sing
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 65 years of age. (2) Fasting blood glucose level is 95 mg / dL or more and less than 126 mg / dL on preliminary examination.
Exclusion criteria
Exclusion criteria: (1) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function. (2) Subjects who routinely use medicines and health foods related to blood glucose level and glucose metabolism. (3) Subjects who have possibilities for emerging allergy related to the study. (4) Subjects who have under treatment (including followup). (5) Subjects who have a history of pancreatic disease, endocrine disease (including diseases related to the thyroid gland), liver disease, gastric resection and other diseases that may cause diabetes / glucose metabolism disorders. (6) Subjects who have a disease requiring continuous medication, or serious medical history who needed medication. (7) Subjects whose clinical laboratory tests, blood pressure, and physical measurements on preliminary examination are significantly out of the standard values. (8) Subjects who have a habit of skipping food on a daily basis, or those who have an extremely irregular diet. (9) Subjects who are engaged in day / night shift work, midnight work, or irregular life habits. (10) Subjects who have been diagnosed with insomnia or sleep apnea, or who have extremely irregular sleep habits. (11) Subjects who have a habit of drinking alcohol more than 5 days in a week. (12) Subjects who have a habit of smoking. (13) Subjects who cannot take the meals provided during the study period or those who cannot take the curry and cooked rice in a completely mixed form. (14) Subjects who plan to travel abroad or domestically for more than a week during the study. (15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (16) Subjects who have participated in other clinical study within the last one month prior to the current study or have participated in other clinical studies. (17) Subjects who intend to become pregnant or lactating. (18) Subjects who are judged as unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of blood glucose level (AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial blood glucose levels, Postprandial maximum blood glucose levels, Postprandial blood insulin level, Incremental area under the curve of blood glucose level (iAUC) | — |
Countries
Japan
Contacts
Public ContactSaki Miyayama
EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section
Outcome results
None listed