A human study fo r evaluating effectiveness and safety o f Agastache rugo se extracts and exercise o n muscle mass and muscle functio n - Applicatio n o f research design based o n big data/artificial intelligence virtual bo dy system
- Conditions
- Not Applicable
- Registration Number
- KCT0006633
- Lead Sponsor
- Ewha Womens University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1) Subject who voluntarily agree to participate and signs informed consent form
2) Aged more than 50 years and less than 75 years, women and men
1)Subjects who cannot participate in resistance exercise program
2)Subject diagnosed with the following diseases
-Renal disease (serum creatinine > 2.0 mg/dL)
-Liver disease(AST or ALT = 3 times the normal upper limit)
-Low hemoglobin(male <11.0 g/dL, female < 10.0 g/dL), platelet count < 75 x103/µL
-Uncontrolled diabetes(HbA1c > 7.0% or frequent hypoglycemia)
-Uncontrolled hypertension (SBP > 150 mmHg or DBP > 90 mmHg)
-Subjects with a history of cardiovascular disease within 3 months of their first visit (cardiomyopathy, angina, heart failure, heart valve disease, stroke, etc.)
-Subjects with damage or disease that affects walking within 6 months of their first fisit ( lower limb fracture, disruptive joint stenosis, severe osteoarthritis, spinal damage, etc.)
-Subjects with cancer history within 5 years of their first visit
-Lung disease ((pneumonia under treatment, pneumonia, chronic obstructive disease), rheumatoid arthritis that requires treatment, telegraphic immune disease, AIDS, alcoholism, dementia, mental illness
3)Subject who has taken oriental medicine or medication that affects muscle function or continuously consumed health functional foods within 2 months of their first visit
-Anabolic steroid (oxandralone, stanozolol), whole body corticosteroids
-Abdrigeb(norethindrone acetate, megestrol acetate, high-dose tibolone), anti-androgen and anti-estrogen(e.g., tamoxifen)
-Recombinant human growth hormone (rhGH), Growth hormone receptor antagonists
-Foods or health functional foods that affect fitness, muscle mass, muscle function improvement: omija extract, protein and amino acid supplements (creatine, rucine, etc.)
4)BMI<18.5 or BMI>30
5)Subject whose muscle mass exceeds the standard range.
6)Subject who participated in aerobics or resistance exercise continuously within 6 months of their first visit
7)Subject whose daily protein intake is significantly higher than Koreans' recommended intake.
8)Subject with hypersensitivity to components contained in the test food or test food
9)Participation in other human study within 1 month before the first visit
10)Subject who has difficult to handle smartphone or computer
11)Any condition that the principal investigator believes may put the subjects at under risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body composition;Body and muscle function - Short physical performance battery,Timed Get Up and Go Test, Six Minute Walk Distance, strength of grasp, Plantar pressure distribution
- Secondary Outcome Measures
Name Time Method biochemical index;metabolomics, transcriptomics