None
Conditions
Interventions
Effectiveness of 4-week intake of test food compared with placebo control
Effectiveness of 4-week intake of test food compared with baseline
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject who meets all the conditions in a screening test 1)Healthy males and females aged from 30 to 60 years (bounds included) 2) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subject having the chronic fatigue syndrome(CFS) , or subject deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3) Subject having a medical history of chest pain or syncope 4) Subject having an abnormality in the electrocardiogram 5)Subject having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations 6)Subjects who take regularly medical supplies or quasi-drugs which having the efficacy on recovery of fatigue or nutrition disorder at physical fatigue 7) Subjects who take regularly the highly-concentrated oxygen water 8) Subject having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 9)Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 10)Female subjects who is pregnant or lactating, or intending to become pregnant during the study 11)Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| analysis of the intestinal microflora, NK cell activity, physical performance tests(10-second high power test, physical working capacity test), autonomic nervous system function(spectrum analysis a-a interval of accelerated plethysmography), skin function tests | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale(VAS), urinary 8-isoprostane | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed