Healthy volunteers
Conditions
Interventions
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 40 years or more and less than 65 years 2) Subjects who perceive fatigue sensation in daily life 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects with chronic fatigue syndrome (CFS), or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator 3) Outpatients with chronic diseases 4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue 5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation or maintaining immune function 6) Subjects who take regularly health food rich in citric acid 7) Subjects who have the possibility of developing allergic symptoms by the test food 8) 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) 9) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 11) Subjects with mental disorders such as depression, with sleep disorders requiring treatment 12) Subjects who have the plan to receive a vaccine such as the influenza vaccine or the COVID-19 vaccine from 2 weeks before to 4 weeks after the start of test food intake 13) Subjects who have the habit to do regularly vigorous exercise (e.g. marathon running) or have the plan to do so during the study 14) Subjects who have the plan to change their lifestyle (sleeping time, eating habits, etc.) significantly during the study 15) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(fatigue sensation) | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS(perceived stress, sleepiness, thirstiness, jitteriness), POMS2 Japanese version, blood test(natural killer cell activity, plasmacytoid dendritic cell activity, macrophage activity), saliva test(secretory immunoglobulin A), questionnaire on physical condition | — |
Countries
Japan
Contacts
Public ContactShinichi Kashiwagi
Soiken Inc. R&D Division
Outcome results
None listed