Effects of consumption of the test food on the knee joint in healthy Japanese subjects
- Conditions
- Healthy subjects (Intended indications and effects: Improvement in discomfort of the knee joint)
- Registration Number
- JPRN-jRCT1030230376
- Lead Sponsor
- Takara Tsuyoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects who have agreed to participate and are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption; Scr)
6. The top 68 subjects with high Japanese Knee Osteoarthritis Measure (JKOM) score at Scr among those who have agreed to participate and meet inclusion criteria No.1~5 and 7 without meeting any of exclusion criteria
7. Subjects who are judged as eligible to participate in the study by the physician
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, or any other heart disease
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatoid arthritis, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take Foods for Specified Health Uses, or Foods with Functional Claims
5. Subjects who are taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
9. Subjects who usually use Foods for Specified Health Uses, or Foods with Functional Claims that affect the knee joint {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide}
10. Subjects who engage in strenuous physical activity {e.g. ball sports (such as soccer, baseball, basketball), jogging, running, skiing, snowboarding} that places a load on the joints
11. Subjects who use a cane or joint support, or may use them during this trial
12. Subjects who are judged as ineligible to participate in this study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method