Healthy adult
Conditions
Interventions
Intake of test food A (single serving) - washout period - placebo B (single serving)
Intake of placebo B (single serving) - washout period - test food A (single serving)
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 70 years of age. (2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who regularly consume foods containing test food ingredients. (2) Subjects who are currently consuming health foods such as foods for health uses or foods with functional claims and cannot discontinue them during participation in this trial. (3) Subjects who may be at risk of developing allergies in relation to the research. (4) Subjects with a history of treatment for malignant tumors, heart failure, or myocardial infarction. (5) Individuals undergoing treatment for chronic diseases or with a medical history. Arrhythmia, liver dysfunction, kidney dysfunction, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases. (6) Subjects who require regular medication, those currently undergoing treatment for a disease, and those with a history of severe diseases that required medication treatment. (7) Subjects with pacemakers or other implantable medical devices. (8) Subjects unable to attach devices for core body temperature measurement (chest) and peripheral temperature measurement (back of the hand), and perform tests according to procedure.hand). (9) Subjects Subjects who are judged to be unsuitable for participation in the study based on their responses to the or pre-intak.. (10) Subjects who work in shifts, night shifts, or have irregular daily schedules. (11) Subjects who participated in other clinical studies during the one-month period prior to study enrollment (pre-screening). (12) Subjects who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study period. (13) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey. (14) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deep body temperature,VAS (fatigue, sleepiness) | — |
Secondary
| Measure | Time frame |
|---|---|
| Core surface temperature, peripheral body temperature, VAS (satiety, cold sensation) | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed