Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Healthy Japanese female aged 40 years or older and younger than 70 years at the time of the informed consent. 2.Subject who feels tired on a daily basis. 3.Subject who usually takes three meals a day. 4.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Heavy drinker 2.Subject who has strong exercise habits. 3.Subject who has experienced chest pain or abnormal pulse at rest. 4.Subject who frequently has palpitations, shortness of breath, lightheadedness, dizziness or loss of consciousness. 5.A family member who has died suddenly for unknown reasons. 6.Subject who has been diagnosed as having problems with the legs. 7.Subject who is receiving the rheumatism treatment. 8.Subject with a history of knee surgery or disease, or who regularly use of cane. 9.Subject with severe hay fever symptoms affecting fatigue. 10.Subject whose protein intake is restricted by a doctor (including mild restrictions). 11.Subject who is taking medication or under medical treatment because of some serious disease. 12.Subject who is under exercise therapy or dietetic therapy. 13.Subject who has an allergy for test food(27 items: milk, soy). 14.Subject who has or had a history of either medicine or alcohol dependence syndrome. 15.Subject who has or had a history of mental illness (depression) or sleep disturbance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Primary efficacy assessment VAS questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 2)Secondary evaluation of effectiveness POMS2 shortened version,body composition,shuttle stamina walk test 3)Safety evaluation Vital signs,biochemical tests, hematological tests,adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed