一项含γ-氨基丁酸和茶氨酸饼干对睡眠质量影响的随机对照研究

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关键词 γ -氨基丁酸;茶氨酸;睡眠障碍;饼干;随机对照研究;有效睡眠时长;临床疗效;安全性

A Randomized Controlled Study on the Effects of GABA-and L-theanine-containing Biscuits or

YANG Geliang1，²，YUAN Jing³，YU Jing³，SONG Yimei3 （1 Shanghai Clinical Research Center，Shanghai 2Ol210，China； 2 Shanghai Institute of Pharmaceutical Clinical Research，Shanghai 200032，China; 3 Shanghai Ezaki Glico Foods Co.，Ltd.，Shanghai 200025，China）

Abstract Objective：To explore the efficacy and safety of biscuits containing γ -aminobutyric acid（GABA）or a combination of GABAand teaL-theanineonsleepquality.Methods：Usingadecentralizedclinical trialdesign，thisopen-labelrandomizedcontrolled studyrecruited participantswithsleepdisordersonlie.Participants wererandomlyasiged（1：1：1：1）intofourgoups： low-dose GABA，high-dose GABA，low-dose GAB+L -theanine，and high-dose GABA + L-theanine. Each group received 15 g of functional biscuits containing 57.5 mg GABA，115 mg GABA，57.5 mg GABA +115 mg L-theanine，or 115 mg GABA +230 mg L-theanine，respectively.Theprimaryeficacyendpointwaseffectivesleepduration.Secondaryendpointsincludeddepsleepduration，energyandfatigue levelsonthe VisualAnalogueScaleforFatigue（VAS-F），andothersleep-relatedindicators.Results： totalof267prtiipantswereenolledSigniicantimprovementsineftivesleepdurationwerebsredacrossallfourgoupsafter intervention（ P<0.05）. Deep sleep duration increased，VAS-F energy scores rose，and fatigue scores decreased significantly （all P<0.05 ）. However，there were no significant changes in sleep latency，percentage of deep sleep，or duration of nocturnal awakenings compared with baseline（ P>0.05， ）. Two mild（Grade 1） adverse events occurred in two participants.Conclusion： Biscuits containingGABAor GABAcombined withL-theaninedemonstrated goodsafetyandpotential eficacyinimproving sleep quality，sugestingthatfunctional foods withtheseingredientsmayofferafeasiblenon-pharmacologicalapproach formanaging mild sleep disturbances.

Keywords γ -aminobutyric acid；L-theanine；Sleep disorder；Functional biscuit; Randomizedcontrolled trial；Effective sleep duration；Clinical efficacy；Safety

中图分类号：R338.63;256.23 文献标识码：A doi：10.3969/j.issn.2095-7130.2025.10.002

睡眠障碍是指睡眠质量和数量的异常，以及在睡眠过程中出现的一系列临床症状[1」。（剩余7416字）