Healthy adults
Conditions
Interventions
Participants will take three capsules of the test food daily for 12 weeks with water or lukewarm water.
Participants will take three capsules of the placebo food daily for 12 weeks with water or lukew
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40 to under 75 2. Japanese men and women 3. BMI less than 30.0 kg/m^2 4. Chronic pain or discomfort in one or both knees for at least six months 5. Able to enter electronic diaries via smartphone or PC 6. Fully informed about the study and voluntarily consented electronically
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment or medication (including Kampo) for any illness 2. Used topical pain medication or analgesics within one month prior to consent or plans to use during the study 3. Under dietary or exercise therapy supervised by a physician 4. History of rheumatoid arthritis, gout, or hyperuricemia 5. Current or past serious illness 6. Receiving treatment at orthopedic pain clinics, chiropractic, osteopathic, or acupuncture clinics 7. History of knee surgery (e.g., artificial joint replacement) or requiring knee surgery 8. Plans for drug therapy for knee joints during the study 9. Intra-articular hyaluronic acid injection within two weeks prior to consent, or steroid injection within three months 10. Knee joint fracture, sprain, or related disease within the past three months 11. Regular use (>=3 times/week) of OTC drugs, quasi-drugs, health foods, supplements, or foods with health claims; participation allowed if discontinued after consent 12. Use of walking aids such as canes or supporters 13. Current or past food or drug allergies 14. Habitual excessive alcohol intake (>=40g pure alcohol/day) 15. Habitual excessive smoking (>=21 cigarettes/day) 16. Shift workers with night shifts 17. Plans to significantly change lifestyle (diet, sleep, exercise) during the study 18. Plans for overseas travel during the study 19. Pregnant, breastfeeding, or planning pregnancy during the study 20. Participation in other clinical trials, within four weeks after completion, or plans to participate after consent 21. Deemed unsuitable by the principal or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JKOM questionnaire at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| JKOM questionnaire at 4 and 8 weeks | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed