Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059224) titled 'Systematic Review on the Effects of Gamma-Aminobutyric Acid (GABA) Supplementation on Sleep Quality' on Sept. 30.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Japan Clinical Trial Association

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study was to examine whether the intake of GABA improves sleep quality in healthy adult men and women, compared to placebo intake, by administering GABA. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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). Key exclusion criteria - Exclude trials that do not meet the selection criteria, such as those including individuals with diseases.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 29 Day Anticipated trial start date - 2025 Year 09 Month 29 Day Last follow-up date - 2026 Year 09 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067466

Disclaimer: Curated by HT Syndication.