Effects of consumption of the test food on the low back

Effects of consumption of the test food on the low back: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on the low back

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060800

Enrollment

Registered

2026-03-02

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Healthy Japanese

Interventions

Duration: 12 weeks The test food Duration: 12 weeks Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are concerned about the low back 6. Individuals who had no osteophytes on X-ray examination 7. Individuals whose JLEQ score is bad

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 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 are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to salmon or gelatin 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who usually use (e.g., glucosamine hydrochloride, chondroitin, collagen peptide, hyaluronic acid, or DHA / EPA) that affect the joint 10. Individuals who plan to start exercise that put intense stress on the low back 11. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measured value of the total score in the Japan low back pain evaluation questionnaire (JLEQ) at 12 weeks after intervention (12w)	—

Secondary

Measure	Time frame
1. The measured values of severity of low back pain, 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 at 12w 2. The measured values of the Japanese Orthopaedic Association (JOA) score, the subjective symptoms score, the objective findings score, the activities of daily living score, and the bladder function score at 12w 3. Improvement rate of JOA score 4. The measured value of Visual Analogue Scale (VAS) at 12w 5. Individuals who experienced adverse events 6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening 7. Physical measurements, urine test, peripheral blood test	—

Measure

Time frame

1. The measured values of severity of low back pain, 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 at 12w 2. The measured values of the Japanese Orthopaedic Association (JOA) score, the subjective symptoms score, the objective findings score, the activities of daily living score, and the bladder function score at 12w 3. Improvement rate of JOA score 4. The measured value of Visual Analogue Scale (VAS) at 12w 5. Individuals who experienced adverse events 6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening 7. Physical measurements, urine test, 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: Jul 3, 2026