Healthy volunteers
Conditions
Interventions
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females aged from 30 to 60 years (bounds included) 2) Subject whose total score of Chalder Fatigue Scale is 21 or more 3) 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 food allergy (gelatin) 4) Subject having a medical history of chest pain or syncope 5) Subject having an abnormality in the electrocardiogram 6) Subject having a subjective symptom of low back pain, arthralgia or lumbar hernia, disease of lower limbs, palpitations 7) Subject who regularly takes medicine or quasi-drugs having the efficacy on recovery of fatigue or nutrition disorder at physical fatigue 8) Subject who regularly takes processed food containing ingredients known to attenuate fatigue sensation 9) Subject who regularly takes food containing large amounts of carotenoid 10) 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) 11) 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 12) Female subject who is pregnant or lactating, or intending to become pregnant during the study 13) Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (VAS), Chalder Fatigue Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Advanced trail making test (ATMT), 10-second high power test, spectrum analysis a-a interval of accelerated plethysmography, POMS 2 Adult Short, OSA sleep inventory MA version, oxidative stress markers, safety evaluation | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed