Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000033446
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Kageyama M, Kobashi R, Tomobe H, Nakajima Y, Akiyoshi K, Ohmori R, Yamada A, Takahashi Y, Takara T. Effects of consumption of the test food containing glucosamine hydrochloride, methylsulfonylmethane, boswellia serrata extract, and olive extract in healthy Japanese subjects with knee joint discomfort: a randomized, double-blinded, placebo-controlled, parallel-group study. Jpn Pharmacol Ther. 2019; 47(12): 2007-2029

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-19
• Study Completion: 2019-04-20
• Results First Posted: 2020-01-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Subjects who are currently taking medications (including herbal medicines) and supplement * Particularly taking anticoagulants such as warfarin 5. Subjects who experience palpitations when they walk fast 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total score of Japanese Knee Osteoarthritis Measure (JKOM) * Compare the amount of change between screening (before consumption) and 12 weeks after consumption

Secondary Outcome Measures

Name	Time	Method
1. JKOM Assess the total score of JKOM and the scores of visual analogue scale (VAS), pain and stiffness in knees, conditions in daily life, general activities, and health conditions 2. The Japanese Orthopaedic Association score for osteoarthritic knees (JOA) Assess JOA scores (the average in both legs, right leg, and left leg) 3. Subjective symptoms related to knee pains (VAS) 4. The 30-second chair stand test Assess the number of times of standing up from the chair for 30 seconds 5. The 10-meter walking test Assesse walking speed, the number of steps, stride length, and waking rate (the number of steps per time) 6. Blood test Assess high sensitivity C-reactive protein, cleavage of type II collagen, and myoglobin *1-6 Assess the items at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change or rate of change. However, the total score of JKOM assesses only the value and rate of change at 12 weeks after consumption.