Normal WeightNCT06185634
Impact of the Timing of Pasta Consumption on Health
A study testing Dietary intervention - Pasta at dinner and Dietary intervention - Pasta at lunch in people with Normal Weight, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Weight
- What is being tested?
- Dietary intervention - Pasta at dinner and Dietary intervention - Pasta at lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 13 Nov 2023to 13 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal weight condition (BMI=18.5-24.9 kg/m2)
- age between 18 and 65 years
- willing to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Unit of Clinical Nutrition, University Hospital of Careggi
Florence, 50134
Francesco Sofi, Prof., +390552758042, francesco.sofi@unifi.it
About this study
Official title: Impact of Pasta Consumption Timing on Multiple Health Outcomes
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.
Read the detailed description
Background:
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
- Normal Weight
- Being tested
- Dietary intervention - Pasta at dinner, Dietary intervention - Pasta at lunch
- Keywords
- Sleep quality, Anthropometric parameters, Mealtiming, Pasta, Cardiovascular risk, Gut microbiota
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention - Pasta at dinnerOther
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 lunchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group starting with the dietary intervention of eating pasta at dinner for 3 months. Receives: 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. Receives: Other: Dietary intervention - Pasta at dinner; Other: Dietary intervention - Pasta at lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (26)
Weight change
Measurement of body weight change in kg at the beginning and end of each of the two intervention phases.
Measured: 7 months
Body mass index (BMI) changes
Measurement of BMI change at the beginning and end of each of the two intervention phases. Weight and height will be combined to report BMI in kg/m^2
Measured: 7 months
Fat mass changes
Measurement of fat mass change at the beginning and end of each of the two intervention phases. Percentage of fat mass will be assessed using the Akern bioelectrical impedance analyser (model SE 101).
Measured: 7 months
Basal Metabolic Rate
Measurement of basale metabolic rate change at the beginning and end of each of the two intervention phases. The basal metabolism will be defined by indirect calorimetry.
Measured: 7 months
Fasting Blood Glucose changes
Measurement of blood glucose concentration change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
Glycated Haemoglobin (HbA1c) changes
Measurement of glycated haemoglobin (HbA1c) change in mmol/mol at the beginning and end of each of the two intervention phases.
Measured: 7 months
Total cholesterol changes
Measurement of total cholesterol change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
LDL-cholesterol changes
Measurement of LDL cholesterol change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
HDL-cholesterol changes
Measurement of HDL cholesterol change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
Triglycerides changes
Measurement of triglycerides change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
Homocysteine changes
Measurement of homocysteine change in micromoli/L at the beginning and end of each of the two intervention phases.
Measured: 7 months
Aspartate transaminase changes
Measurement of aspartate transaminase change in U/l at the beginning and end of each of the two intervention phases.
Measured: 7 months
Alanine transaminase changes
Measurement of alanine transaminase change in U/l at the beginning and end of each of the two intervention phases.
Measured: 7 months
Gamma-glutamyl transferase changes
Measurement of gamma-glutamyl transferase change in U/l at the beginning and end of each of the two intervention phases.
Measured: 7 months
Urea changes
Measurement of urea change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
Creatinine changes
Measurement of creatinine change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
Uric acid changes
Measurement of uric acid change in mg/dL at the beginning and end of each of the two intervention phases.
Measured: 7 months
Gut microbiota changes
Measurement of gut microbiota profile change at the beginning and end of each of the two intervention phases. Each subject will be asked for a stool sample at the beginning and at the end of each intervention phases in order to analyse the composition of the gut microbiota and short-chain fatty acids production.
Measured: 7 months
Individual circadian rhythms
Circadian rhythms and the individual chronotype will be analysed for each participant through the Dim Light Melatonin Onset (DMLO) at the beginning and end of each of the two intervention phases. For this purpose, the NovoLytiX ELISA kit for Direct Melatonin on Saliva (EK-DSM) will be used.
Measured: 7 months
TBARS changes
Measurement of TBARS changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
ROS changes
Measurement of ROS changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
Leptin changes
Measurement of leptin changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
Ghrelin changes
Measurement of ghrelin changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
Insulin changes
Measurement of insulin changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
IL-6 changes
Measurement of IL-6 changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
C-Peptide YY
Measurement of C-Peptide YY changes at the beginning and end of each of the two intervention phases.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start13 Nov 2023
- Primary completion13 Nov 2025 (estimated)
- Study completion13 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Normal WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The experimental study will be a randomised controlled trial and will involve 2 phases of nutritional intervention.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185634
- Sponsor's protocol ID
- PASTA-TIMING
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34308127Henry 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.
PubMed 32075959St-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.
PubMed 27633109Frazier 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.
PubMed 31677970la 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.
PubMed 11375322Afaghi 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.
PubMed 17284739Thaiss 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.
PubMed 27912059Zhao 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.
PubMed 32684833Gerard 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.
PubMed 30761090Lotti 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.
PubMed 34549270Lotti 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.
PubMed 40340858
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pasta Consumption Timing on Multiple Health Outcomes
- ClinicalTrials.gov ID
- NCT06185634
- Acronym / sponsor ID
- PASTA-TIMING
- Conditions
- Normal Weight
- Keywords
- Sleep quality, Anthropometric parameters, Mealtiming, Pasta, Cardiovascular risk, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 13 Nov 2025 (estimated)
- Study completion
- 13 Nov 2025 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental study will be a randomised controlled trial and will involve 2 phases of nutritional intervention.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Dietary intervention - Pasta at dinner, Other: Dietary intervention - Pasta at lunchGroup starting with the dietary intervention of eating pasta at dinner for 3 months. |
| Group 2 | Experimental | Other: Dietary intervention - Pasta at dinner, Other: Dietary intervention - Pasta at lunchGroup starting with the dietary intervention of eating pasta at lunch for 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- normal weight condition (BMI=18.5-24.9 kg/m2)
- age between 18 and 65 years
- willing to give informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention - Pasta at dinnerThe "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. | Other | Group 1, Group 2 |
| Dietary intervention - Pasta at lunchThe "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. | Other | Group 1, Group 2 |
Primary outcome
Sleep quality
Time frame: 7 months
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.
26 secondary outcomes
Weight change
Time frame: 7 months
Body mass index (BMI) changes
Time frame: 7 months
Fat mass changes
Time frame: 7 months
Basal Metabolic Rate
Time frame: 7 months
Fasting Blood Glucose changes
Time frame: 7 months
Glycated Haemoglobin (HbA1c) changes
Time frame: 7 months
Total cholesterol changes
Time frame: 7 months
LDL-cholesterol changes
Time frame: 7 months
HDL-cholesterol changes
Time frame: 7 months
Triglycerides changes
Time frame: 7 months
Homocysteine changes
Time frame: 7 months
Aspartate transaminase changes
Time frame: 7 months
Alanine transaminase changes
Time frame: 7 months
Gamma-glutamyl transferase changes
Time frame: 7 months
Urea changes
Time frame: 7 months
Creatinine changes
Time frame: 7 months
Uric acid changes
Time frame: 7 months
Gut microbiota changes
Time frame: 7 months
Individual circadian rhythms
Time frame: 7 months
TBARS changes
Time frame: 7 months
ROS changes
Time frame: 7 months
Leptin changes
Time frame: 7 months
Ghrelin changes
Time frame: 7 months
Insulin changes
Time frame: 7 months
IL-6 changes
Time frame: 7 months
C-Peptide YY
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 34308127Huang 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.
- Background: PubMed 32075959Henry 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.
- Background: PubMed 27633109St-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.
- Background: PubMed 31677970Frazier 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.
- Background: PubMed 11375322la 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.
- Background: PubMed 17284739Afaghi 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.
- Background: PubMed 27912059Thaiss 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.
- Background: PubMed 32684833Zhao 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.
- Background: PubMed 30761090Gerard 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.
- Background: PubMed 34549270Lotti 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.
- Derived from this study: PubMed 40340858Lotti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention - Pasta at dinner and Dietary intervention - Pasta at lunch in people with Normal Weight, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Sofi, MD, PhD (+390552758042, francesco.sofi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185634, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.