Impact of the Timing of Pasta Consumption on Health

NCT06185634 | Unknown

• 1 other identifier: PASTA-TIMING
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To date, the optimal timing for pasta consumption remains uncertain. Based on recent evidence in the field of chrono-nutrition, it is speculated that eating pasta at dinner may have a negative impact on cardio-metabolic health. Carbohydrate intake during a period of minimal glucose tolerance could potentially alter the glycaemic profile and increase the risk of overweight and obesity. Conversely, other studies indicate that consuming carbohydrates at dinner may enhance sleep efficiency and quality. Thus, the aim of this study is, for the first time, to evaluate whether there are discernible differences between consuming pasta at lunch or dinner for the human health.

Conditions

Normal Weight

Keywords

Sleep quality; Anthropometric parameters; Mealtiming; Pasta; Cardiovascular risk; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  The assessment of sleep quality will be done by actigraphy and the following parameters will be evaluated: sleep onset time, end of sleep time, waking after sleep onset, total sleep time, sleep efficiency, number of awakenings, duration of awakenings, movement index, activity index and sleep regularity index.This assessment will be carried out at the beginning and end of each of the two intervention phases.

  7 months

Secondary Outcomes (26)

• Weight change

  7 months

• Body mass index (BMI) changes

  7 months

• Fat mass changes

  7 months

• Basal Metabolic Rate

  7 months

• Fasting Blood Glucose changes

  7 months

Study Arms (2)

Group 1

EXPERIMENTAL

Group starting with the dietary intervention of eating pasta at dinner for 3 months.

Other: Dietary intervention - Pasta at dinner; Other: Dietary intervention - Pasta at lunch

Group 2

EXPERIMENTAL

Group starting with the dietary intervention of eating pasta at lunch for 3 months.

Other: Dietary intervention - Pasta at dinner; Other: Dietary intervention - Pasta at lunch

Interventions

Dietary intervention - Pasta at dinner OTHER

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.

Group 1; Group 2

Dietary intervention - Pasta at lunch OTHER

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 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normal weight condition (BMI=18.5-24.9 kg/m2)
• age between 18 and 65 years
• willing to give informed consent

You may not qualify if:

• subjects who were involved in night work, planned long-distance jet travel during the study period, had irregular sleeping schedules or were taking any drugs known to affect sleep or metabolism
• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Unit of Clinical Nutrition, University Hospital of Careggi

Florence, 50134, Italy

RECRUITING

Related Publications (11)

• 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.

  PMID: 34308127 BACKGROUND

• 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.

  PMID: 32075959 BACKGROUND

• 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.

  PMID: 27633109 BACKGROUND

• 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.

  PMID: 31677970 BACKGROUND

• 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.

  PMID: 11375322 BACKGROUND

• 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.

  PMID: 17284739 BACKGROUND

• 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.

  PMID: 27912059 BACKGROUND

• 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.

  PMID: 32684833 BACKGROUND

• 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.

  PMID: 30761090 BACKGROUND

• 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.

  PMID: 34549270 BACKGROUND

• 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.

  PMID: 40340858 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Francesco Sofi, MD, PhD

CONTACT

+390552758042; francesco.sofi@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study it will not be possible to blind the experimenters and participants. Blinding will be impossible for the experimenters, as they will provide the food plan with the dietary intervention. Blinding will also not be possible for the participants, who will have to eat pasta only at dinner for 3 months and only at lunch for the same period of time.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The experimental study will be a randomised controlled trial and will involve 2 phases of nutritional intervention.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: November 13, 2023
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

IT (1)