Healthy Adults
Conditions
Interventions
None listed
Sponsors
Japan Clinical Trial Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants (P) Healthy adult men and women were included. Individuals with diagnosed diseases, minors, pregnant or lactating women were excluded. Those with temporary sleep-related concerns were considered healthy if they met no exclusion criteria, but were categorized separately from those without such concerns. Sleep concerns were defined as temporary and distinct from clinical sleep disorders. Intervention (I) The intervention was oral intake of GABA-containing food products. Previous studies have employed intake durations ranging from one to twelve weeks. However, considering that prolonged supplementation may extend beyond the scope of transient sleep-related complaints and potentially influence broader physiological parameters, studies exceeding four weeks were, as a general protocol, designed with stratified cohorts to account for duration-dependent effects. All previous studies used 100 mg of GABA, which was adopted as the assumed effective dose. Studies with higher or lower doses were considered for subgroup analysis. Studies without clear dosage information were excluded. Comparison (C) The comparison was oral intake of food products without GABA. Studies containing ingredients known to affect sleep were excluded unless the amount was negligible or deemed not to influence outcomes. All qualifying studies were grouped together without further subdivision. Outcome (O) The primary outcome was improvement in sleep quality. EEG measurement was considered essential, following recommendations by the Japanese Society of Sleep Research. Additionally, subjective assessments of sleep restfulness were included, based on the Ministry of Health's "Sleep Guidelines for Health Promotion 2023." Subjective measures included the Visual Analog Scale (VAS), Pittsburgh Sleep Quality Index (PSQI), and Oguri-Shirakawa-Azumi Sleep Inventory for Middle-Aged and Aged (OSA-MA).
Exclusion criteria
Exclusion criteria: Exclude trials that do not meet the selection criteria, such as those including individuals with diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalography,VAS,Pittsburgh Sleep Quality Index,OSA-MA | — |
Countries
Japan
Contacts
Public ContactTakeshi Kaneko
Japan Clinical Trial Association N/A
Outcome results
None listed