A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females

Not Applicable

• Conditions: Healthy adult

• Registration Number: JPRN-UMIN000026673
• Lead Sponsor: TTC Co.,Ltd.

Brief Summary

GABA significantly decreased the total non-rapid eye movement (non-REM) sleep stage 2. In stratified analysis based on stress, the total time of non-REM sleep stage 3 in the layer above the mean value of confusion-bewilderment, anger-hostility, tension-anxiety, total mood disturbance score of the Profile of Mood States 2nd edition (POMS2) were significantly increased in the GABA intake period compared to the placebo. In stratified analysis by fatigue feeling, the total time of non-REM sleep stage 3 at the time of ingesting GABA in the layer where the fatigue VAS prior to ingestion exceeded the average value significantly increased compared to placebo. Stratified analysis based on age, the total time of non-REM sleep stage 3 at the time of ingestion of GABA in the stratum above the average age was significantly increased compared to placebo.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fatigue: Fatigue VAS Sleep: OSA Sleep Inventory for Middle-Aged and Aged