Healthy adult
Conditions
Interventions
Intake of a GABA - containing food for 2 consecutive weeks - washout period of 2 weeks - intake of placebo for 2 consecutive weeks
Intake of placebo for 2 consecutive weeks - washout period of 2 weeks
Sponsors
TTC Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female workers from 30 to 59 years of age 2) Pittsburgh sleep quality index global score is greater than or equal to 6 3) POMS 2-AS FI T score is greater than or equal to 50 and VA T score is less than or equal to 50
Exclusion criteria
Exclusion criteria: 1) Subjects who routinely use food or medicine containing of GABA 2) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep, and stress 3) Subjects who routinely intake foods that possibly affect sleep, stress, and fatigue 4) Subjects who wake after sleep onset for nocturia twice and more than twice a week 5) Subjects who have a possibility of feeling stress and affecting sleep due to abstinence 6) Subjects who have a history of hay fever 7) Night and day shift worker or manual laborer 8) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor 9) Subjects who have under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome 10) Subjects who have had a diagnosis of chronic fatigue syndrome 11) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires 13) Subjects having possibilities for emerging allergy related to the study 14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 15) 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 16) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 17) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stress: POMS 2-A Short Sleep: electroencephalography | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue: Fatigue VAS Sleep: OSA Sleep Inventory for Middle-Aged and Aged | — |
Countries
Japan
Contacts
Public ContactHiroyasu Shimada
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed