Healthy adults
Conditions
Interventions
Intake 2 packages of test food a day for 8 days. Rest 4 weeks. Intake 2 packages of control food a day for 8 days.
Intake 2 packages of control food a day for 8 days. Rest 4 weeks. Intake 2 packages o
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females of Japanese aged 20 to 64 years old. (2) Subjects who don't have exercise habituation on a daily basis. (3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Exclusion criteria
Exclusion criteria: Subjects who 1)are given continuous treatment by taking medicines. 2)ingest food for specified health use, functional foods, health foods and supplements (rich containing proteins, peptides and/or amino acids) more than 3 days a week. 3)use medicines that possibly have the influence for fatigue feeling more than 3 days a week. Subjects who ingest food for specified health use, functional foods, health foods and/or supplements those possibly have the influence for fatigue feeling more than 3 days a week. 4)are pregnant or lactating, and females who could become pregnant or lactating during test period. 5)have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ) containing history of surgical operations. 6)excessive alcohol intake. 7)smoke 8)have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 9)have previous medical history of drug and/or food allergy (especially to wheat and/or to soy bean). 10)are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 11)donated over 200mL blood and/or blood components within the last one month to the current study. 12)donated over 400mL blood and/or blood components within the last three month to the current study. And 13)Females who donated over 400mL blood and/or blood components within the last four month to the current study. 14)Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 15)Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (16)Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Visual Analog Scale questionnaire of fatigue feeling (before exercise load, just after exercise load finished, 30 min after exercise load finished, 60 min after exercise load finished and a day after exercise load finished) 2.Blood biochemical test (CPK) 3.Plasma TGF-beta concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Plasma cytokine concentration (IL-6, TNF-alfa) 2.NK-cell activity 3.Blood amino acid concentration (Gln, BCAA, Trp) 4.Blood biochemical test (AST, ALT, LDH, gamma-GTP, BUN, CRE) 5.Borg scale questionnaire (before exercise load, just after exercise load finished) 6.POMS short version (before exercise load, 60 min after exercise load finished) 7.Incidence rate of adverse events and side effects 8.Others (body weight, BMI, blood pressure and systolic blood pressure, diastolic blood pressure and pulse rate) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Planning and Sales Department
Outcome results
None listed