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Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult wome

Not Applicable
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000039587
Lead Sponsor
HUMA R&D CORP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
30
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1)Primary efficacy assessment VAS questionnaire
Secondary Outcome Measures
NameTimeMethod
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
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