Healthy subjects
Conditions
Interventions
Maintenance of body temperature and intake of the test food
Maintenance of body temperature and intake of the control food
Thermal load to increase body temperature and intake of the test food
Thermal
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subject who gave written consent for participation in the research 2) Healthy male 3) Age at the time of obtaining consent is 20 to 40 years old 4) Body mass index (BMI) is 18.5 or more and less than 25 (normal weight) 5) Subject who habitually eats breakfast for 4 days or more in a week 6) Subject who does not work in shifts or night shift 7) Right-handed subject 8) Subject who does not smoke 9) Subject who can carry out the test according to the schedule and procedure specified by the researcher
Exclusion criteria
Exclusion criteria: 1) Subject who has collected 200 mL or more of whole blood within 4 weeks, or 400 mL or more of whole blood within 12 weeks, prior to the first blood collection 2) Subject whose clinical laboratory test values deviate from the normal range and are judged by the principal investigator to be ineligible for this study 3) Subject with any medical history of brain, nerve, psychiatry, circulatory system, endocrine function, or color vision deficiency who is judged by the principal investigator to be ineligible for this study 4) Subject whose rise in sublingual temperature is 1 degree Celsius or more, or less than 0.1 degree Celsius during the thermal load performed at a screening test 5) Subject whose total number of correct answers in Kraepelin test conducted at the screening test exceeds the average value plus-minus 2SD 6) Subject who cannot drink the specified amount of the test food 7) Subject who has used health foods or drugs and the principal investigator has determined that the usage affect the evaluation of the outcomes 8) Subject who is estimated inappropriate to this study by principal investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Evaluation items) Changes in the result of Uchida Kraepelin test, Stroop test, and Paced Auditory Serial Addition Test (PASAT); changes in body temperature; changes in cerebral blood flow; changes in the result of subjective evaluation questionnaire by Visual Analog Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Exploratory evaluation items) Heart rate and heart rate variability, blood glucose level, hematocrit level, and serum osmolality (Safety evaluation) Frequency of adverse events during the study, general physical findings, and vital signs | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed