Male/female adults
Conditions
Interventions
Consumption of the test food (1 bottle [150 g] per day) for 4 weeks
Consumption of the placebo food (1 bottle [150 g] per day) for 4 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy men and women aged 20 to below 65 years at the time of consent acquisition. 2. Subjects who feel fatigued even after resting during daily activities. 3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims (such as GABA, imidazole peptides, reduced coenzyme Q10, L-theanine, citric acid, etc.), or health supplements (including those that might affect the study) three or more times per week and cannot stop consumption from the time of consent. 2. Subjects who are taking medications (such as Alinamin A, Chocola BB, etc.) that might affect the study and cannot restrict their use during the study period. 3. Subjects with excessive alcohol intake. 4. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials. 5. Subjects engaged in physical labor or those who regularly perform excessive physical exercise. 6. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 7. Females who are pregnant or lactating, and females who could become pregnant during trial period. 8. Subjects with allergies to medications and/or food. 9. Subjects who donated blood or component (200 mL) within the last 1 months. 10. Subjects who donated his blood (400 mL) within the last 3 months. 11. Subjects who donated her blood (400 mL) within the last 4 months. 12. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study. 13. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study. 14. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Questionnaire: Visual Analog Scale (VAS) for overall fatigue, physical fatigue, and mental fatigue Profile of Mood States 2nd Edition (POMS2) Short Form (Japanese version) Quality of Life Questionnaire: SF-36 (Short Form Health Survey) | — |
Secondary
| Measure | Time frame |
|---|---|
| Accelerated Pulse Wave Antioxidant Tests: Blood d-ROMs (diacron-Reactive Oxygen Metabolites) Blood BAP (Biological Antioxidant Potential) Blood MDA (Malondialdehyde) by TBARS (2-Thiobarbituric Acid Reactive Substances) Urinary 8-OHdG (8-Hydroxy-2'-deoxyguanosine) Saliva Tests: Cortisol Chromogranin A | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed