Healthy adult
Conditions
Interventions
Intake the research food for 12 consecutive weeks
Intake the placebo food for 12 consecutive weeks
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 64 years old (2) The ALT level in the range from 31 to 50 U/L, and the AST level is relatively high will be considered first
Exclusion criteria
Exclusion criteria: (1) Subjects who ALT levels >= 51 U / L or AST levels >= 51 U / L or gamma-GTP levels >= 101 U / L on the preliminary examination (2) Subjects who are positive for HCV antibody or HbsAg on the preliminary examination (3) Subjects who cannot accomplish the intact inspection procedure as prescribed (4) Subjects who are judged as unsuitable for the study based on the results of the lifestyle questionnaire (5) Subjects who constantly use health food richly containing involvement ingredient (6) Subjects who constantly use supplements or drugs affecting the liver function (7) Subjects who constantly use supplements or drugs affecting the status of fatigue, mood, and sleep (8) Subjects who have serious illnesses such as diabetes, liver disease, kidney disease, heart disease, and cancer or history of those illnesses (9) Subjects having possibilities for emerging allergy related to the study (10) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (13) Subjects who intend to become pregnant or lactating during the test period (14) Subjects who habitually do intense exercise such as marathon. (15) Subjects who take constant or frequent night shifts (16) Subjects judged as unsuitable for the study by the principle investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function indexes (ALT and AST) before the study and 4, 8, and 12 weeks after using the test food | — |
Secondary
| Measure | Time frame |
|---|---|
| gamma-GTP, ALP, Fatigue VAS, Japanese short version of POMS2, OSA sleep inventory MA version at before the study and 4, 8, 12 weeks after using the test food | — |
Countries
Japan
Contacts
Public ContactKei Yasui
EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department
Outcome results
None listed