MedPath

Effects of consumption of the test food on shoulder stiffness in healthy Japanese subjects

Not Applicable
Conditions
Healthy Japanese subjects
Registration Number
JPRN-UMIN000047710
Lead Sponsor
ORTHOMEDICO Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
56
Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects whose the cause of eye diseases, entropion, trichiasis, rotator cuff tear, meningitis, high astigmatism, high myopia, premature ovarian failure, tension-type headache, shoulder stiffness can be considered other than fatigue associated with VDT operation. 5. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who suffer from COVID-19 10. 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 11. 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
NameTimeMethod
1. Result of participant responding "My shoulder and neck are stiff" using subjective symptoms assessment with Likert scale after VDT (visual display terminals) load at 12 weeks after consumption (12w)
Secondary Outcome Measures
NameTimeMethod
1. Result of participant responding "My shoulder and neck are stiff" using subjective symptoms assessment with Likert scale before VDT load at 12w 2. Result of participant responding the following items using subjective symptoms assessment with Likert scale before and after VDT load at 12w: "my eyes are tired", "my eyes are painful", "my vision is blurred", "I have tears", "I have bloodshot eyes", "my vision flickers", "I have double vision", "I am annoyed", "my head feels heavy", and "I have a headache" 3. The muscular stiffness of shoulders, and HFC-1 (high frequency component) measured using the autorefkeratometer at 12w (before and after VDT load and the difference between them)
© Copyright 2025. All Rights Reserved by MedPath