Healthy adults
Conditions
Interventions
Participants will take one sachet of the test food daily with water for 12 weeks.
Participants will take one sachet of the placebo food daily with water for 12 weeks.
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to under 65 at consent. 2. Able to enter study diary via smartphone or PC. 3. Fully informed of the study purpose and research content, able to consent, and voluntarily agreed in writing to participate.
Exclusion criteria
Exclusion criteria: 1. History or presence of serious diseases: malignancy, respiratory, hepatic, renal, cardiac, pulmonary, gastrointestinal (including history of surgery affecting digestion/absorption), hematologic, endocrine, metabolic disorders, drug/alcohol dependence, psychiatric disorders. 2. Currently receiving treatment for any disease with medication or Kampo (as-needed drugs excluded). 3. BMI >=30.0 kg/m^2. 4. History or presence of drug or food allergies. 5. Severe anemia. 6. History of adverse reactions to blood sampling, vasovagal response, or difficulty with blood draws. 7. Pregnant, planning pregnancy during the study, or breastfeeding. 8. Heavy smokers (>=21 cigarettes/day). 9. Average daily alcohol intake >40 g (pure alcohol). 10. Unable to discontinue over-the-counter drugs, quasi-drugs, foods with health claims, or supplements during the study. 11. Scheduled for endoscopy, barium study, H. pylori eradication, or tooth extraction during the study. 12. Scheduled for vaccination during the study. 13. Women who donated >=400 mL blood within 16 weeks, men within 12 weeks, or anyone who donated >=200 mL within 4 weeks prior to consent. 14. Night shift/rotating workers, manual laborers, or those with irregular lifestyles, or likely to change lifestyle during the study. 15. Receiving physician-supervised exercise, dietary, or health guidance. 16. Participating in other studies involving food, drugs, cosmetics, or had participated in another clinical study within 4 weeks before consent. 17. Deemed unsuitable by the principal investigator based on background, physical findings, interview, vital signs, or lab results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, side effects, physical examinations (body measurements, blood pressure, pulse), clinical tests (hematology, biochemistry, urinalysis), and physician interviews | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed