MedPath

Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects

Not Applicable
Conditions
Healthy Japanese subjects
Registration Number
JPRN-UMIN000048119
Lead Sponsor
ORTHOMEDICO Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Male
Target Recruitment
63
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 who have lactose intolerance 5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk) 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9. Subjects who suffer from COVID-19 10. Subjects who cannot perform the specified training 11. 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 12. 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
ean mass at 12 weeks after consumption (12w)
Secondary Outcome Measures
NameTimeMethod
Cross-sectional area of rectus abdominis muscle, cross-sectional area of abdominal oblique muscle, total cross-sectional area of rectus abdominis muscle and abdominal oblique muscle, grip strength (right hand, left hand, and both hands average), the number of times of standing up from the chair for 30 seconds, the number of times of raising upper body for 30 seconds, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass (right arm, left arm, right leg, left leg, and trunk (torso)), and muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)} at 12w
© Copyright 2025. All Rights Reserved by MedPath