Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) : an open-label study

Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) : an open-label study - Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061971

Enrollment

Registered

2026-06-19

Start date

2026-06-19

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Duration: 12 weeks Test product: Product containing food Administration: Consume two tablets twice daily (morning and night, in total four tablets a day) with water. *If a take is missed, it shoul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who have a past medical history of disc herniation 6. Individuals who are judged as eligible to participate in the study by the physician according to the results of X-ray examination at Scr 7. Individuals whose score of JLEQ is bad at Scr

Exclusion criteria

Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medications or foods related to the test product (particularly citrus fruits) 7. Individuals who are pregnant, lactating, or planning pregnancy during this study 8. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Design outcomes

Primary

Measure	Time frame
1. The measured values of the score of Japan Low back pain Evaluation Questionnaire (JLEQ) at 12 weeks after consumption (12w)	—

Secondary

Measure	Time frame
1. The measured values of severity of low back pain measured by Visual Analogue Scale (VAS), low back pain during the past few days, problems in daily living due to low back pain during the past few days, and general health and mental condition during the past month and others of the JLEQ at 12w 2. The measured values of pain intensity in knees measured by VAS, the score, pain and stiffness in knees, activities of daily living, social activities, and general health conditions of the Japanese Knee Osteoarthritis Measure (JKOM) at 12w 3. The measured values of pain, range of motion, muscle strength, general health, ability of daily living, and ability for sports of the Shoulder 36 at 12w 4. Individuals whose responses to each item in the JKOM, JLEQ, and Shoulder 36 improved by one or more scales at 12w 5. The measured values of high sensitivity C-reactive protein (CRP) at 12w 6. Individuals who experienced adverse events 7. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening (Scr) 8. Physical measurements, urinalysis, and peripheral blood test	—

Measure

Time frame

1. The measured values of severity of low back pain measured by Visual Analogue Scale (VAS), low back pain during the past few days, problems in daily living due to low back pain during the past few days, and general health and mental condition during the past month and others of the JLEQ at 12w 2. The measured values of pain intensity in knees measured by VAS, the score, pain and stiffness in knees, activities of daily living, social activities, and general health conditions of the Japanese Knee Osteoarthritis Measure (JKOM) at 12w 3. The measured values of pain, range of motion, muscle strength, general health, ability of daily living, and ability for sports of the Shoulder 36 at 12w 4. Individuals whose responses to each item in the JKOM, JLEQ, and Shoulder 36 improved by one or more scales at 12w 5. The measured values of high sensitivity C-reactive protein (CRP) at 12w 6. Individuals who experienced adverse events 7. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening (Scr) 8. Physical measurements, urinalysis, and peripheral blood test

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026