Healthy volunteer
Conditions
Interventions
Ingestion of supplement for eight weeks.
Ingestion of placebo for eight weeks.
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged 30 to 60 years at that time of study participation agreement. 2)Subject who are feeling fatigue nearly every day. 3)Weekday workers (Monday to Friday or Monday to Saturday service). 4)Subjects who were evaluated "fatigue" >=50 and "vigor" <=50 of T score in subscale of POMS Japanese version. 5)Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing. 6)Subjects who were deemed appropriate to participate in the study by the investigator.
Exclusion criteria
Exclusion criteria: 1)Subjects who are undergoing medication suffer from some sort of disease. 2)Subjects who are during pregnancy or lactation, and possibility of pregnancy during the study period. 3)Subjects who have alimentary allergy. 4)Subjects who have a intake habit of continued medicines, quasi-drugs, food with health claims (food for specified health use), health foods and supplements such currently or within the past three months, furthermore going to their intake during the study period. 5)Subjects who have previous history or present illness of cardiovascular disease, nephritis, hepatitis, pancreatitis, and so on. 6)Subjects who have previous history of serious disability of liver, kidney, heart, lung, blood, and so on. 7)Subjects who have comorbidity and previous history of digestive system. 8)Subjects who have diagnosis history or strongly suspected of insomnia, sleep apnea syndrome, depression and menopause. 9)Subjects who have diagnosis history of chronic fatigue syndrome or idiopathic chronic fatigue. 10)Subjects who systolic blood pressure is 140 mmHg or more, or diastolic blood pressure is greater than or equal to 90 mmHg at rest. 11)Subjects who are ingesting alcohol in excessive (alcohol in terms of 60 g or more per day). 12)Subjects who are planning to travel abroad or more than three days and two -nights of travel during the study period. 13)Subjects who are a blood donation of more than 200 mL in the past one month, or more than 400 mL in the past three months. 14)Subjects who are participating in other clinical trial or three months has not elapsed after joining other clinical trials. 15)Subjects who were deemed inappropriate to participate in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue sensation (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| POMS Japanese version Blood concentration of MDA-LDL and CoQ10 oxidation rate | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. Representative Director
Outcome results
None listed