Healthy adult
Conditions
Interventions
Single dose of 200 mL of the test food
Single dose of 400 mL of the test food
Single dose of 600 mL of the test food
Single dose of 200 mL of the placebo food
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy adult males aged >= 20 and < 40 years (2) Subjects with a BMI of 18.5 kg/m2 or higher but less than 25.0 kg/m2 at the time of the baseline assessment (3) Subjects judged to be healthy based on baseline assessment results (4) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: (1) Subjects receiving treatment with any therapeutic drug (2) Subjects following diet and exercise therapy under a physician's supervision (3) Subjects with a current serious illness (4) Subjects with a history of gastrointestinal surgery (excluding appendectomy) or gastrointestinal disorders (5) Subjects with a smoking habit (6) Subjects regularly using medications, quasi-drugs, or health foods (e.g., FOSHU, foods with functional claims, supplements) three or more times weekly (7) Subjects adhering to dietary restrictions such as low-carbohydrate, low-protein, or ketogenic diets (8) Subjects with a history of food or drug allergies (9) Subjects participating in other clinical studies, or who completed another clinical study within one month prior to enrollment (10) Subjects who underwent blood sampling of more than 200 mL or 400 mL within one month prior to study start (11) Subjects who work in shifts, work late at night, and have an irregular daily rhythm (12) Subjects who tested positive for infection in screening performed upon admission for hospitalization (13) Subjects who are judged to be unsuitable for participation in the study based on their responses to the lifestyle questionnaire (14) Subjects deemed ineligible for participation based on baseline assessment results (15) Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ketone bodies fractionation | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary ketone bodies, blood glucose, venous blood gas analysis (pH, PO2, PCO2, HCO3-, BE) | — |
Countries
Japan
Contacts
Public ContactSaki Fukuchi
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed