Healthy Volunteers
Conditions
Interventions
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects whose age of 40 years or more and less than 65 years 2) Subjects who were evaluated 40 or more in T score of "fatigue-inertia" in subscale of POMS2 short version 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects having the chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3) Subjects having a medical history of chest pain or syncope 4) Subjects deemed unsuitable in the electrocardiogram by the investigator 5) Subjects having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations 6) Subjects who have the possibility of developing allergic symptoms by the test food 7) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue 8) Subjects who take regularly supplements of protein or amino acid drink 9) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 10) Subjects 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) 11) Subjects who took part in another clinical study within 1 month prior to the start of the present study or who is currently taking part in another clinical study 12) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 13) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS (fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Chalder fatigue scale, T score of "fatigue-inertia" in subscale of POMS2 short version, Performance test (10-second high power test) after 4-week intake | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. Representative Director
Outcome results
None listed