A study for evaluating the effect of the intake of a GABA-containing food on stress and sleep in worker: randomized, placebo-controlled, double blind trial

Not Applicable

• Conditions: Healthy adult

• Registration Number: JPRN-UMIN000019308
• Lead Sponsor: TTC Co.,Ltd.

Brief Summary

Compared with the placebo group, the GABA group showed a significant increase the vigor-activity scale measured by POMS 2 at week 6 relative to the baseline (P=0.045).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-10
• Study Completion: 2016-02-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects who routinely use food or medicine containing of GABA 2) Subjects who performs an act for the improvement of the fatigue, the quality of the sleep and stress 3) Night and day shift worker or manual laborer 4) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor 5) Subjects who has under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome 6) Subjects who has had a diagnosis of chronic fatigue syndrome 7) Subjects who has 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 8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnair 9) Subjects having possibilities for emerging allergy related to the study 10) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 11) 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 12) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 13) Subjects who are judged as unsuitable for the study by the investigator for other reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep : PSQI Stress : POMS 2-A Short

Secondary Outcome Measures

Name	Time	Method
Sleep : AIS Fatigue : VAS