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. 2025 May 8;26(1):150.
doi: 10.1186/s13063-025-08859-x.

The impact of the timing of pasta intake on sleep quality and health outcomes: a protocol for a randomized controlled trial

S Lotti  1 , M Dinu  2 , A Napoletano  1 , G Pagliai  1 , M Tristan Asensi  1 , I Giangrandi  3 , F Cesari  4 , M Becatti  5 , A Amedei  1 , C Fiorillo  5 , R Marcucci  1   6 , B Colombini  1 , F Sofi  1   3
Affiliations

The impact of the timing of pasta intake on sleep quality and health outcomes: a protocol for a randomized controlled trial

S Lotti et al. Trials. .

Abstract

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.

Keywords: Carbohydrate timing; Cardiometabolic health; Circadian rhythms; Gut microbiota; Sleep.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: The study protocol was reviewed and approved by the Ethics Committee of the University of Florence (n spe123.23, version 2.0, date 26/09/2023). The study will be conducted in accordance with the Declaration of Helsinki and the Data Protection Act. Ethics Committee approval included the study protocol, information sheet and consent form, questionnaires, interviews, any other written information that will be provided to participants, and any advertising that will be used during the study. The study is registered at the Clinical Trials Registry (clinicaltrials.gov: NCT06185634, registered on 07/01/2024) in accordance with the requirements of the International Committee of Medical Journal editors (ICMJE). Consent for publication {32}: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28}: The authors declare that they have no competing interests, and the research is not being supported by any commercial organization.

Figures

Fig. 1
Fig. 1
SPIRIT figure reporting the phases of the trial and data collection time points
Fig. 2
Fig. 2
Organization of the intervention study
See this image and copyright information in PMC

References

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