Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 20 to under 65 2. Japanese men and women 3. BMI less than 30.0 kg/m^2 4. Able to enter electronic diaries via smartphone or PC 5. Provided written informed consent after receiving a full explanation of the study and voluntarily agreeing to participate
Exclusion criteria
Exclusion criteria: 1. Currently receiving outpatient treatment or medication (including Kampo) for any illness 2. Under physician-supervised dietary or exercise therapy 3. Current or past history of serious disease 4. Currently taking over-the-counter drugs, quasi-drugs, Foods for Specified Health Uses, Foods with Functional Claims, health foods, or supplements (except those who can discontinue use after consent and during the study) 5. Current or past drug or food allergies 6. Excessive alcohol consumption (>=40g pure alcohol/day) 7. Heavy smoking (>=21 cigarettes/day) 8. Shift workers with night shifts 9. Planning major lifestyle changes (diet, sleep, exercise, etc.) during the study 10. Planning overseas travel during the study period 11. Pregnant, breastfeeding, or planning pregnancy during the study 12. Participated in another clinical study within one month prior to consent, currently participating, or planning to participate during the study 13. Deemed unsuitable for participation by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Physical examination (weight, BMI) -Physiological assessments (blood pressure, pulse) -Blood tests (hematology, blood biochemistry) -Urinalysis -Incidence of adverse events and side effects | — |
Countries
Japan
Contacts
IMEQRD Co., Ltd. Planning and Sales Department