Evidence map›Paper›PMID 40340858›Full record

ArticleTrials2025

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

S Lotti, M Dinu, A Napoletano, G Pagliai, M Tristan Asensi, I Giangrandi, F Cesari, M Becatti, A Amedei, C Fiorillo and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06185634 (Impact of Pasta Consumption Timing on Multiple Health Outcomes), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06185634 naunknown statusnot on this map

Impact of Pasta Consumption Timing on Multiple Health Outcomes

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria CareggiRan2023 to 2025Enrolled70ConditionsNormal WeightArmsDietary intervention - Pasta at dinner, Dietary intervention - Pasta at lunch
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

S LottiDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
M DinuDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy. monica.dinu@unifi.it.
A NapoletanoDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
G PagliaiDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
M Tristan AsensiDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
I GiangrandiUnit of Clinical Nutrition, Careggi University Hospital, Florence, Italy.
F CesariCentral Laboratory, Careggi University Hospital, Florence, Italy.
M BecattiDepartment of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
A AmedeiDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
C FiorilloDepartment of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
R MarcucciDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
B ColombiniDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.
F SofiDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPasta 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.

methodsA 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 registrationClinicalTrials.gov NCT06185634. Registered on 07/01/2024.

Indexed as

Dietary CarbohydratesDiet, MediterraneanSleepSleep QualityAdultCircadian RhythmCross-Over StudiesFemaleGastrointestinal MicrobiomeHumansMaleRandomized Controlled Trials as TopicTime FactorsYoung AdultDietary CarbohydratesCarbohydrate timingCardiometabolic healthCircadian rhythmsGut microbiotaSleep

Identifiers

PMID40340858
PMCPMC12063442

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.