Healthy subjects
Conditions
Interventions
Test foods consumption for 12 weeks.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese men and women aged 45 to 65 years old at the time of informed consent. 2)Subject who is worried about muscle weakness. 3)Subject who can measure physical fitness. 4)Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing. 5)Subject who can continuously take the test food for 12 weeks during the test period. 6)Subject who is judged not to be sick by the interview with the investigator.
Exclusion criteria
Exclusion criteria: 1)Subject who is currently undergoing medication or outpatient treatment due to some serious illness or knee or low back pain. 2) Heavy drinkers. 3)Subject who has suffered severe damage to the locomotorium such as fractures, tendon ruptures, and pulled muscle in the last year. 4)Subject who has experienced strong chest pain or abnormal pulse at rest. 5)Subject who uses a pacemaker or artificial joints. 6)Subject who frequently has palpitation, shortness of breath, lightheadedness, dizziness or loss of consciousness. 7)Subject diagnosed with leg and waist disorders. 8)Subject who has a history of knee surgery, has a disease, or uses a cane on a daily basis. 9)Subject who has high-intensity exercise habits. 10)Subject who is under exercise therapy or diet therapy. 11)Subject who has an allergy for test food. 12)Subject who has or had a history of either medicine or alcohol dependence syndrome. 13)Subject who has or had a history of mental illness (ex. depression) or sleep disturbance. 14)Subject who has irregular work rhythms such as working at night and shift work. 15)Subject who has extremely irregular lifestyle such as eating and sleeping.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body composition (skeletal muscle mass, basal metabolic rate, protein mass, body fat mass, body weight, BMI, muscle mass, body fat percentage, upper limb muscle mass, trunk muscle mass, leg muscle mass, body water content) | — |
Secondary
| Measure | Time frame |
|---|---|
| Special blood test (TNF-alpha, IL-6), Chalder Fatigue Scale, VAS questionnaire, subjective symptom questionnaire, motor ability test (lower limb muscle strength, grip strength, eye-opening one-leg standing test, 6-minute walk test, 6-m walk test, 2 steps test, 10 times chair stand-up test) | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed