Tokyo, Dec. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060008) titled 'A Study on the Effects of the Test Food on Knee Joints in Healthy Individuals' on Dec. 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of 12 weeks of continuous intake of the test food on knee joints in healthy men and women aged 40 to under 75 who experience knee pain or discomfort but are not undergoing treatment.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will take three capsules of the test food daily for 12 weeks with water or lukewarm water.
Interventions/Control_2 - Participants will take three capsules of the placebo food daily for 12 weeks with water or lukewarm water.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key 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
Key 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
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 18 Day
Anticipated trial start date - 2026 Year 01 Month 28 Day
Last follow-up date - 2026 Year 04 Month 22 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068619
Disclaimer: Curated by HT Syndication.
