Study Results
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Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2023-11-13
2025-11-13
Brief Summary
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Detailed Description
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Pasta plays an indisputable role in the Mediterranean diet pyramid. Indeed, it is an excellent source of carbohydrates that can be part of a varied, balanced, and healthy diet. Despite this, more and more people are avoiding it because they consider it too caloric and associate it with weight gain, especially if eaten in the evening.
While it is known with certainty that the consumption of pasta, in the right quantities, is associated with positive health effects, there is limited information on the optimal time to consume it. The most common hypothesis is that it is better to consume it at lunch, as metabolism undergoes a physiological and progressive reduction as the evening approaches. Furthermore, recent findings in the field of chrono-nutrition have highlighted that glucose tolerance is high during the day and minimal during the night, suggesting that consuming a high amount of carbohydrates in the evening may predispose to weight gain and a worsened cardio-metabolic profile. On the other hand, according to some studies, consuming carbohydrates in the evening may ensure good sleep quality, as they are an excellent source of tryptophan, an amino acid that promotes serotonin production, also known as the sleep hormone.
Recently, some studies on animal models have suggested that the timing of carbohydrate consumption could also impact the composition and functionality of the gut microbiota. For example, it has been observed that the production of short-chain fatty acids (SCFA) fluctuates throughout the day under the control of the host's circadian rhythms. Considering that SCFA are produced from carbohydrates and are fundamental regulators for many metabolic processes, it could be extremely interesting to explore the relationship between "when carbohydrates are consumed" and microbial functionality.
In conclusion, to date, studies that have evaluated the timing of carbohydrate consumption are limited and rely on physiological and chrono-biological assumptions rather than experimental evidence. Consequently, it is not known whether consuming pasta at lunch or dinner, in the right quantities, may have effects on human weight and health.
Objective of the study:
The aim of this study is to assess, for the first time, whether there is a difference between consuming pasta at lunch or dinner in terms of sleep quality, anthropometric parameters, cardiovascular risk factors, composition and functionality of the gut microbiota in a sample of normal-weight subjects. Additionally, individual chronotype will be taken into consideration, a construct indicating when a subject is most active during the day, as recent studies have highlighted its impact on dietary habits, especially in terms of "meal timing," and human health.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
Group starting with the dietary intervention of eating pasta at dinner for 3 months.
Dietary intervention - Pasta at dinner
The "pasta at dinner" nutritional intervention will consist, as the name suggests, in eating pasta at dinner for 3 months. The dietary intervention will consist of a normo-caloric diet, defined on the basis of the individual basal metabolic rate measured by indirect calorimetry and on the calculation of the participant's calorie intake extrapolated from a 3-day food diary. The diet will be of the Mediterranean type with 30% of energy coming from fats, 15-20% from proteins and the remaining 50-55% from carbohydrates (mainly complexes). Calorie intake will be distributed as follows: 20% calories at breakfast, 5% calories in the mid-morning snack, 40% calories at lunch, 5% calories in the mid-afternoon snack, 30% calories at dinner.
Dietary intervention - Pasta at lunch
The "pasta at lunch" nutritional intervention will consist, as the name suggests, in eating pasta at lunch for 3 months. The dietary intervention will consist of a normo-caloric diet, defined on the basis of the individual basal metabolic rate measured by indirect calorimetry and on the calculation of the participant's calorie intake extrapolated from a 3-day food diary. The diet will be of the Mediterranean type with 30% of energy coming from fats, 15-20% from proteins and the remaining 50-55% from carbohydrates (mainly complexes). Calorie intake will be distributed as follows: 20% calories at breakfast, 5% calories in the mid-morning snack, 40% calories at lunch, 5% calories in the mid-afternoon snack, 30% calories at dinner.
Group 2
Group starting with the dietary intervention of eating pasta at lunch for 3 months.
Dietary intervention - Pasta at dinner
The "pasta at dinner" nutritional intervention will consist, as the name suggests, in eating pasta at dinner for 3 months. The dietary intervention will consist of a normo-caloric diet, defined on the basis of the individual basal metabolic rate measured by indirect calorimetry and on the calculation of the participant's calorie intake extrapolated from a 3-day food diary. The diet will be of the Mediterranean type with 30% of energy coming from fats, 15-20% from proteins and the remaining 50-55% from carbohydrates (mainly complexes). Calorie intake will be distributed as follows: 20% calories at breakfast, 5% calories in the mid-morning snack, 40% calories at lunch, 5% calories in the mid-afternoon snack, 30% calories at dinner.
Dietary intervention - Pasta at lunch
The "pasta at lunch" nutritional intervention will consist, as the name suggests, in eating pasta at lunch for 3 months. The dietary intervention will consist of a normo-caloric diet, defined on the basis of the individual basal metabolic rate measured by indirect calorimetry and on the calculation of the participant's calorie intake extrapolated from a 3-day food diary. The diet will be of the Mediterranean type with 30% of energy coming from fats, 15-20% from proteins and the remaining 50-55% from carbohydrates (mainly complexes). Calorie intake will be distributed as follows: 20% calories at breakfast, 5% calories in the mid-morning snack, 40% calories at lunch, 5% calories in the mid-afternoon snack, 30% calories at dinner.
Interventions
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Dietary intervention - Pasta at dinner
The "pasta at dinner" nutritional intervention will consist, as the name suggests, in eating pasta at dinner for 3 months. The dietary intervention will consist of a normo-caloric diet, defined on the basis of the individual basal metabolic rate measured by indirect calorimetry and on the calculation of the participant's calorie intake extrapolated from a 3-day food diary. The diet will be of the Mediterranean type with 30% of energy coming from fats, 15-20% from proteins and the remaining 50-55% from carbohydrates (mainly complexes). Calorie intake will be distributed as follows: 20% calories at breakfast, 5% calories in the mid-morning snack, 40% calories at lunch, 5% calories in the mid-afternoon snack, 30% calories at dinner.
Dietary intervention - Pasta at lunch
The "pasta at lunch" nutritional intervention will consist, as the name suggests, in eating pasta at lunch for 3 months. The dietary intervention will consist of a normo-caloric diet, defined on the basis of the individual basal metabolic rate measured by indirect calorimetry and on the calculation of the participant's calorie intake extrapolated from a 3-day food diary. The diet will be of the Mediterranean type with 30% of energy coming from fats, 15-20% from proteins and the remaining 50-55% from carbohydrates (mainly complexes). Calorie intake will be distributed as follows: 20% calories at breakfast, 5% calories in the mid-morning snack, 40% calories at lunch, 5% calories in the mid-afternoon snack, 30% calories at dinner.
Eligibility Criteria
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Inclusion Criteria
* age between 18 and 65 years
* willing to give informed consent
Exclusion Criteria
* presence of current chronic illness or unstable condition (e.g., cardiovascular disease, chronic liver disease, inflammatory bowel disease)
* current or recent (past 2 months) use of antibiotics or probiotics
* pregnancy or intention to become pregnant in the next 12 months
* breastfeeding
18 Years
65 Years
ALL
Yes
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Francesco Sofi
Professor
Locations
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Unit of Clinical Nutrition, University Hospital of Careggi
Florence, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Huang M, Lo K, Li J, Allison M, Wu WC, Liu S. Pasta meal intake in relation to risks of type 2 diabetes and atherosclerotic cardiovascular disease in postmenopausal women : findings from the Women's Health Initiative. BMJ Nutr Prev Health. 2021 Apr 30;4(1):195-205. doi: 10.1136/bmjnph-2020-000198. eCollection 2021.
Henry CJ, Kaur B, Quek RYC. Chrononutrition in the management of diabetes. Nutr Diabetes. 2020 Feb 19;10(1):6. doi: 10.1038/s41387-020-0109-6.
St-Onge MP, Mikic A, Pietrolungo CE. Effects of Diet on Sleep Quality. Adv Nutr. 2016 Sep 15;7(5):938-49. doi: 10.3945/an.116.012336. Print 2016 Sep.
Frazier K, Chang EB. Intersection of the Gut Microbiome and Circadian Rhythms in Metabolism. Trends Endocrinol Metab. 2020 Jan;31(1):25-36. doi: 10.1016/j.tem.2019.08.013. Epub 2019 Oct 31.
la Fleur SE, Kalsbeek A, Wortel J, Fekkes ML, Buijs RM. A daily rhythm in glucose tolerance: a role for the suprachiasmatic nucleus. Diabetes. 2001 Jun;50(6):1237-43. doi: 10.2337/diabetes.50.6.1237.
Afaghi A, O'Connor H, Chow CM. High-glycemic-index carbohydrate meals shorten sleep onset. Am J Clin Nutr. 2007 Feb;85(2):426-30. doi: 10.1093/ajcn/85.2.426.
Thaiss CA, Levy M, Korem T, Dohnalova L, Shapiro H, Jaitin DA, David E, Winter DR, Gury-BenAri M, Tatirovsky E, Tuganbaev T, Federici S, Zmora N, Zeevi D, Dori-Bachash M, Pevsner-Fischer M, Kartvelishvily E, Brandis A, Harmelin A, Shibolet O, Halpern Z, Honda K, Amit I, Segal E, Elinav E. Microbiota Diurnal Rhythmicity Programs Host Transcriptome Oscillations. Cell. 2016 Dec 1;167(6):1495-1510.e12. doi: 10.1016/j.cell.2016.11.003.
Zhao M, Tuo H, Wang S, Zhao L. The Effects of Dietary Nutrition on Sleep and Sleep Disorders. Mediators Inflamm. 2020 Jun 25;2020:3142874. doi: 10.1155/2020/3142874. eCollection 2020.
Gerard C, Vidal H. Impact of Gut Microbiota on Host Glycemic Control. Front Endocrinol (Lausanne). 2019 Jan 30;10:29. doi: 10.3389/fendo.2019.00029. eCollection 2019.
Lotti S, Pagliai G, Colombini B, Sofi F, Dinu M. Chronotype Differences in Energy Intake, Cardiometabolic Risk Parameters, Cancer, and Depression: A Systematic Review with Meta-Analysis of Observational Studies. Adv Nutr. 2022 Feb 1;13(1):269-281. doi: 10.1093/advances/nmab115.
Lotti S, Dinu M, Napoletano A, Pagliai G, Asensi MT, Giangrandi I, Cesari F, Becatti M, Amedei A, Fiorillo C, Marcucci R, Colombini B, Sofi F. The impact of the timing of pasta intake on sleep quality and health outcomes: a protocol for a randomized controlled trial. Trials. 2025 May 8;26(1):150. doi: 10.1186/s13063-025-08859-x.
Other Identifiers
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PASTA-TIMING
Identifier Type: -
Identifier Source: org_study_id
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