Liu Hui, Shangguan Fuliang, Liu Fen, Guo Yu, Yu Huixi, Li Hanbing, Su Yinhua, Li Zhongyu
School of Nursing, Hengyang Medical School, University of South China, Hengyang, Hunan, China.
The First Affliated Hospital, University of South China, Hengyang, Hunan, China.
PLoS One. 2025 Jan 9;20(1):e0316333. doi: 10.1371/journal.pone.0316333. eCollection 2025.
Time-restricted eating (TRE) manages weight effectively, but choosing how long and what time window remain debatable. Although an 8:00 a.m. to 16:00 p.m. time frame is reported to show positive results in most weight loss trial, its safety and efficacy in overweight and obese women with polycystic ovary syndrome (PCOS) is uncertain. This randomized controlled trial is conducted to evaluate the safety and efficacy of TRE in specific populations.
This study aims to assess the 6-month effects of TRE on weight change, metabolic improvement, reproductive recovery, and health-related quality of life in overweight and obese women with polycystic ovary syndrome (PCOS), compared to those who did not receive TRE.
This randomized controlled trial will enroll 96 overweight and obese women with polycystic ovary syndrome (PCOS), who will be randomly assigned to either a TRE group (with an eating window from 8:00 a.m. to 16:00 p.m.) or a control group (without eating time restrictions), with 49 participants in each group. Evaluators and data analysts will remain blinded to group allocation throughout the study. The primary outcomes, including changes in weight and body mass index (BMI), will be assessed weekly. Secondary outcomes, encompassing alterations in sex hormones, metabolic parameters, body composition, sleep quality, quality of life, anxiety, and depression, will be evaluated monthly. Compliance and safety will be continuously monitored throughout the study. Additionally, a 6-month follow-up will be conducted at the end of the trial to assess the long-term effects of TRE. Statistical analysis will include the Anderson-Darling test for normality, T-test/Wilcoxon test based on distribution, mixed-effects models for assessing time/group effects, Cox model for time-to-event analysis, repeated ANOVA for change analysis, and sensitivity analysis. All tests will be conducted using appropriate software, with a significance level set at P<0.05. Missing data will be imputed.
The purpose of this study protocol is to further evaluate the effects of TRE in overweight and obese women with PCOS through a randomized controlled trial (RCT). Findings from this study are expected to provide new dietary intervention strategies for overweight and obese PCOS participants.
This study has received ethics approval from the Medical Ethics Committee of the University of South China (Number: NHHL027). Participants are included after signing informed consent. Results will be submitted for publication in peer-reviewed journals.
Trail registration number: ChiCTR2400086815.
限时进食（TRE）能有效控制体重，但进食时长和时间段的选择仍存在争议。尽管多数减肥试验报告称上午8点至下午4点的时间段显示出积极效果，但其对超重及肥胖的多囊卵巢综合征（PCOS）女性的安全性和有效性尚不确定。本随机对照试验旨在评估TRE在特定人群中的安全性和有效性。
本研究旨在评估与未接受TRE的超重及肥胖的多囊卵巢综合征（PCOS）女性相比，TRE对体重变化、代谢改善、生殖恢复以及健康相关生活质量的6个月影响。
本随机对照试验将招募96名超重及肥胖的多囊卵巢综合征（PCOS）女性，她们将被随机分配至TRE组（进食窗口为上午8点至下午4点）或对照组（无进食时间限制），每组49名参与者。在整个研究过程中，评估人员和数据分析人员将对分组情况保持盲态。主要结局指标，包括体重和体重指数（BMI）的变化，将每周评估一次。次要结局指标，包括性激素、代谢参数、身体成分、睡眠质量、生活质量、焦虑和抑郁的改变，将每月评估一次。在整个研究过程中，将持续监测依从性和安全性。此外，在试验结束时将进行6个月的随访，以评估TRE的长期效果。统计分析将包括用于正态性检验的Anderson-Darling检验、基于分布的t检验/ Wilcoxon检验、用于评估时间/组效应的混合效应模型、用于事件发生时间分析的Cox模型、用于变化分析的重复方差分析以及敏感性分析。所有检验将使用适当的软件进行，显著性水平设定为P<0.05。缺失数据将进行插补。
本研究方案的目的是通过随机对照试验（RCT）进一步评估TRE对超重及肥胖的PCOS女性的影响。预计本研究结果将为超重及肥胖的PCOS参与者提供新的饮食干预策略。
本研究已获得南华大学医学伦理委员会的伦理批准（编号：NHHL027）。参与者在签署知情同意书后被纳入研究。研究结果将提交至同行评审期刊发表。
试验注册号：ChiCTR2400086815。
