Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059471) titled 'A systematic review of the role of gamma-aminobutyric acid (GABA) in alleviating temporary mental stress' on Oct. 20.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - FANCL Corporation

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

Objective: Narrative objectives1 - The objective of this study is to verify whether gamma-aminobutyric acid (GABA) has the function of alleviating temporary mental stress. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - P: Participant The subjects were healthy adults (those who are not suffering from any diseases, excluding those under 18 years old, pregnant women, and lactating women).

I: Intervention (food) characteristics Continuous intake of gamma-aminobutyric acid (GABA), Unlimited dosage forms, shapes and amounts.

C: Comparison group Placebo or a similar food that did not contain gamma-aminobutyric acid (GABA).

O: Evaluation items Main outcomes: Brain waves, heart rate variability, stress-related substances in saliva (cortisol, alpha-amylase, chromogranin A) Secondary outcomes: subjective evaluation (POMS, VAS, etc) In this SR, we will use the value at the time of assessment provided in each document, unless otherwise specified or unknown, in order to avoid multiplicity issues, we will use the value at the time of the last intervention. Furthermore, if a single study had multiple assessment time points, results from all reported assessment time points were used.

S: Research design The research designs used in the literature were randomized parallel group controlled trials (RCTPs), randomized crossover trials (RCTCOs), and quasi-randomized controlled trials (quasi-RCTs). In addition, the languages of presentation were documents written in Japanese and English. As a general rule, the presentation format will be an original paper, and papers in the form of short reports or summaries will also be accepted if the content can be specified. Abstracts of academic conference presentations (conference minutes) were excluded because their descriptive content was considered insufficient. There was no question as to whether or not the journal in which the article was published had been peer-reviewed. To avoid publication bias, we also included studies with results published in clinical trial registry databases. Regarding gray literature, we decided to use doctoral theses, reports from government agencies, think tanks, etc. whose detailed contents could be identified. Key exclusion criteria - The literature which does not meet the key inclusion criteria will be excluded.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 20 Day Last follow-up date - 2025 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068023

Disclaimer: Curated by HT Syndication.