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

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 - A study for evaluating the effect of the intake of a GABA-containing food on stress and sleep in worker

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019308

Enrollment

Registered

2015-10-10

Start date

2015-10-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Ingestion of test food containing GABA for 12 consecutive weeks Ingestion of placebo without GABA for 12 consecutive weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females from 30 to 60 years of age 2) worker (full-time) 3) AIS score is more than 6 4) POMS 2-A FI T score is more than 50 and VA T score is less than 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Sleep : PSQI Stress : POMS 2-A Short	—

Secondary

Measure	Time frame
Sleep : AIS Fatigue : VAS	—

Countries

Japan

Contacts

Public ContactHiroyasu Shimada

TTC Co., Ltd. Clinical Research Planning Department

h.shimada@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026