面食摄入时间对睡眠质量和健康结果的影响:一项随机对照试验方案
The impact of the timing of pasta intake on sleep quality and health outcomes: a protocol for a randomized controlled trial.
作者信息
Lotti S, Dinu M, Napoletano A, Pagliai G, Asensi M Tristan, Giangrandi I, Cesari F, Becatti M, Amedei A, Fiorillo C, Marcucci R, Colombini B, Sofi F
机构信息
Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy.
出版信息
Trials. 2025 May 8;26(1):150. doi: 10.1186/s13063-025-08859-x.
BACKGROUND
Pasta is a fundamental component of the Mediterranean diet and a key source of carbohydrates. Despite its nutritional benefits, misconceptions persist regarding its potential to promote weight gain, particularly when consumed at dinner. While no evidence supports this concern, emerging chrononutritional research suggests that evening carbohydrate intake may positively influence sleep quality by promoting serotonin production. This study aims to assess, for the first time, whether pasta consumption (lunch vs. dinner) affects sleep quality, circadian rhythms, cardiometabolic health, and gut microbiota composition in healthy, normal-weight adults.
METHODS
A 7-month randomized, open-label, cross-over trial will enroll 70 participants, assigned to two isocaloric, Mediterranean-style diets differing only in pasta consumption timing. Each phase will last 3 months, separated by a 1-month wash-out period. At the beginning and end of each phase, participants will wear an actigraph for 7 days and provide saliva, blood, and stool samples. Additional assessments include body composition analysis, indirect calorimetry, and food and lifestyle diaries. The primary outcome will be changes in sleep quality from baseline. Secondary outcomes include anthropometric measurements, body composition, metabolic rate, biochemical and hormonal markers, inflammatory and oxidative stress markers, gut microbiota composition, and short-chain fatty acid production. The study has been approved by the Tuscany Regional Ethics Committee of the Azienda Ospedaliera Universitaria (AOU)-Careggi, Florence.
DISCUSSION
This study will provide experimental data on how the timing of pasta consumption affects sleep quality and a range of health outcomes, contributing to the debate on the optimal timing of carbohydrate intake.
TRIAL REGISTRATION
ClinicalTrials.gov NCT06185634. Registered on 07/01/2024.
背景
面食是地中海饮食的基本组成部分,也是碳水化合物的主要来源。尽管面食有营养益处,但关于其可能导致体重增加的误解仍然存在,尤其是晚餐食用时。虽然没有证据支持这一担忧,但新出现的时间营养学研究表明,晚间碳水化合物摄入可能通过促进血清素的产生对睡眠质量产生积极影响。本研究旨在首次评估面食消费时间(午餐与晚餐)对健康、体重正常的成年人的睡眠质量、昼夜节律、心脏代谢健康和肠道微生物群组成的影响。
方法
一项为期7个月的随机、开放标签、交叉试验将招募70名参与者,他们被分配到两种等热量的地中海式饮食中,仅面食消费时间不同。每个阶段将持续3个月,中间有1个月的洗脱期。在每个阶段开始和结束时,参与者将佩戴活动记录仪7天,并提供唾液、血液和粪便样本。其他评估包括身体成分分析、间接测热法以及饮食和生活方式日记。主要结果将是睡眠质量相对于基线的变化。次要结果包括人体测量、身体成分、代谢率、生化和激素指标、炎症和氧化应激指标、肠道微生物群组成以及短链脂肪酸的产生。该研究已获得佛罗伦萨大学医院(AOU)-卡雷吉托斯卡纳地区伦理委员会的批准。
讨论
本研究将提供关于面食消费时间如何影响睡眠质量和一系列健康结果的实验数据,为碳水化合物摄入最佳时间的辩论做出贡献。
试验注册
ClinicalTrials.gov NCT06185634。于2024年1月7日注册。