Overweight and ObesityCHRONODIETNCT05941871
Chronotype-adapted Diet and Weight Loss
A study testing Dietary intervention - intervention group in people with Overweight and Obesity, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
In humans, prolonged alterations in the circadian rhythm have been linked to cognitive impairments, premature ageing, and oncological and metabolic disorders such as diabetes and obesity. Obesity, in particular, is an ever-increasing condition with innumerable deleterious effects on human health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Dietary intervention - intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2023to 6 Mar 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
- overweight or obese condition (BMI≥25 kg/m2)
- age between 18 and 65 years
- willing to give informes consent
Who cannot join
- chronic illnesses or unstable conditions (e.g. cancer, kidney or liver disease, inflammatory-intestinal disease, cognitive decline, psychiatric disease)
- drug therapies (use of corticosteroids, antidiabetic drugs)
- pregnancy or intention to become pregnant in the next 12 months
- breastfeeding
- current or recent (last 3 months) adoption of a low-calorie diet
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: Diet and Chronotype: a Randomized Controlled Trial to Evaluate the Effects of a Chronotype-adapted Diet on Weight Loss in Overweight/Obese Subjects
In humans, prolonged alterations in the circadian rhythm have been linked to cognitive impairments, premature ageing, and oncological and metabolic disorders such as diabetes and obesity. Obesity, in particular, is an ever-increasing condition with innumerable deleterious effects on human health. In recent years, studies have shown a relationship between a person's chronotype (morning or evening) and eating habits, as well as the importance of adapting these habits to physiological rhythms. Furthermore, it has been suggested that customising the caloric distribution of meals according to personal circadian rhythms may influence body weight and be one of the strategies to control overweight and obesity. In spite of the strong interest in this topic and the increasing number of observational studies conducted, there is currently a lack of intervention studies evaluating whether a low-calorie diet that takes into account the individual chronotype may be more effective than a standard low-calorie diet in the treatment of overweight and/or obesity.
Read the detailed description
Background
Society has changed enormously in recent decades and this has had a strong impact on the processes regulating circadian rhythms, in particular the sleep-wake and fasting-eating cycles. The 'normalisation' of the environment, favoured by technological progress, has in fact caused light pollution, noise pollution, excessive thermoregulation, continuous work shifts and disordered eating, leading to an uncoordinated circadian cycle with consequences on physical and mental balance. In humans, prolonged alterations of the biological clock have been linked to cognitive disorders, premature ageing, and oncological and metabolic diseases such as diabetes and obesity. Obesity, in particular, is a condition with innumerable negative effects on human health.
In recent years, a new branch of nutritional research has aroused growing interest in the scientific community: this is chrono-nutrition, which combines elements of nutritional research with elements of chronobiology and studies the impact of eating times on health. The first to use the term "chrono-dystrophy" as a chronic desynchronisation of circadian rhythms were Erren and colleagues, who in their work reported how a loss of synchronisation between environmental signals and physiological processes can lead to alterations in the communication between the central nervous system and peripheral clocks and a change in the subject's metabolism. Subsequently, numerous studies have evaluated the impact of the thirteen dimensions of eating behaviour - timing, frequency and regularity - on health, hypothesising a possible role of the individual circadian rhythm, or chronotype, on the risk of developing overweight and/or obesity. Recent data have demonstrated a relationship between a person's chronotype (morning or evening) and eating habits, as well as the importance of adapting these habits to physiological rhythms. Furthermore, it has been suggested that customising the caloric distribution of meals according to personal circadian rhythms may influence body weight and be one of the strategies to control overweight and obesity. Indeed, recent research has shown that calories ingested at different times of the day have different effects on energy utilisation, leading to differential weight loss, even in the presence of isocaloric quantities.
Despite the strong interest in this topic and the increasing number of observational studies conducted, there is currently a lack of intervention studies evaluating whether a dietary regimen can be used to control body weight. Evidence to date suggests that in order to increase the effectiveness of low-calorie diets, it may be of great interest to consider not only patients' daily energy expenditure but also their circadian preferences. Overall, chrono-nutrition could mediate the effects between sleep, diet and urbanisation, but further research is needed to elucidate the precise physiological and metabolic mechanisms underlying this phenomenon, the importance of chronotype for metabolic health and its impact on public health.
Objectives of the study
The objectives of the study are to compare the effects of a diet with a daily calorie distribution adapted to the individual chronotype with a control diet with a conventional daily calorie distribution. The primary outcome is weight change from baseline. Secondary outcomes are changes in body mass index (BMI), percentage of fat mass, biochemical parameters and gut microbiota profile.
- Conditions
- Overweight and Obesity
- Being tested
- Dietary intervention - intervention group, Dietary intervention - control group
- Keywords
- Chrono-nutrition, Circadian rhythms, Chronotype, Weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention - intervention groupOther
Low-calorie diet for 4 months with a different daily energy distribution according to the chronotype:
- Morning chronotype: 50% of kcal administered before lunch and 15% in the second part of the day (specifically: 40% at breakfast, 10% in the morning snack, 35% at lunch, 5% at afternoon snack and 10% at dinner)
- Evening chronotype: 15% of kcal given before lunch and 50% in the second half of the day (specifically: 10% of kcal at breakfast, 5% in the morning snack, 35% at lunch, 10% at snack time and 40% at dinner)
Dietary intervention - control groupOther
Group that will follow a low-calorie diet with a standard daily energy distribution (20% of kcal at breakfast, 10% in the morning snack, 35% at lunch, 10% at afternoon snack and 25% at dinner) for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Group that will follow a low-calorie diet with a standard daily energy distribution for 4 months Receives: Other: Dietary intervention - control group |
| Intervention | Experimental | Group following a low-calorie diet with a different daily energy distribution according to their chronotype for 4 months Receives: Other: Dietary intervention - intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measurement of body weight change from baseline in kg
Measured: 4 months
Secondary outcomes (14)
Body mass index (BMI) changes
Measurement of BMI change from baseline. Weight and height will be combined to report BMI in kg/m^2
Measured: 4 months
Fat mass changes
Measurement of fat mass change from baseline. Percentage of fat mass will be assessed using the Akern bioelectrical impedance analyser (model SE 101)
Measured: 4 months
Fasting Blood Glucose changes
Measurement of blood glucose concentration change from baseline in mg/dL
Measured: 4 months
Total cholesterol changes
Measurement of total cholesterol change from baseline in mg/dL
Measured: 4 months
LDL-cholesterol changes
Measurement of LDL cholesterol change from baseline in mg/dL
Measured: 4 months
HDL-cholesterol changes
Measurement of HDL cholesterol change from baseline in mg/dL
Measured: 4 months
Triglycerides changes
Measurement of triglycerides change from baseline in mg/dL
Measured: 4 months
Aspartate transaminase changes
Measurement of aspartate transaminase change from baseline in U/l
Measured: 4 months
Alanine transaminase changes
Measurement of alanine transaminase change from baseline in U/L
Measured: 4 months
Gamma gamma-glutamyl transferase changes
Measurement of gamma-glutamyl transferase change from baseline in U/L
Measured: 4 months
Urea changes
Measurement of urea change from baseline in mg/dL
Measured: 4 months
Creatinine changes
Measurement of creatinin change from baseline in mg/dL
Measured: 4 months
Uric acid changes
Measurement of uric acid change from baseline in mg/dL
Measured: 4 months
Gut microbiota changes
Measurement of gut microbiota profile change from baseline. Each subject will be asked for a stool sample at the start of the study and at the end after 4 months in order to analyse the composition of the gut microbiota and short-chain fatty acids production
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start6 Mar 2023
- Primary completion6 Mar 2025 (estimated)
- Study completion6 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Parallel groups
- Model description
- Randomised and controlled trial with 2 arms of intervention
- Masking
- None (open label)
- Enrolment
- 150 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
- Investigators
- Francesco Sofi, MD, PhD, Study director, Unit of Clinical Nutrition University Hospital of Careggi, Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941871
- Sponsor's protocol ID
- CHRONODIET
- Acronym
- CHRONODIET
- Status last verified
- Jul 2023
- First submitted
- 18 May 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almoosawi S, Vingeliene S, Gachon F, Voortman T, Palla L, Johnston JD, Van Dam RM, Darimont C, Karagounis LG. Chronotype: Implications for Epidemiologic Studies on Chrono-Nutrition and Cardiometabolic Health. Adv Nutr. 2019 Jan 1;10(1):30-42. doi: 10.1093/advances/nmy070.
PubMed 30500869Erren TC, Reiter RJ. Defining chronodisruption. J Pineal Res. 2009 Apr;46(3):245-7. doi: 10.1111/j.1600-079X.2009.00665.x. Epub 2009 Feb 9.
PubMed 19215573Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
PubMed 1027738Galindo Munoz JS, Gomez Gallego M, Diaz Soler I, Barbera Ortega MC, Martinez Caceres CM, Hernandez Morante JJ. Effect of a chronotype-adjusted diet on weight loss effectiveness: A randomized clinical trial. Clin Nutr. 2020 Apr;39(4):1041-1048. doi: 10.1016/j.clnu.2019.05.012. Epub 2019 May 21.
PubMed 31153674Lotti 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 34549270Maukonen M, Kanerva N, Partonen T, Kronholm E, Konttinen H, Wennman H, Mannisto S. The associations between chronotype, a healthy diet and obesity. Chronobiol Int. 2016;33(8):972-81. doi: 10.1080/07420528.2016.1183022. Epub 2016 May 31.
PubMed 27246115Maukonen M, Kanerva N, Partonen T, Kronholm E, Tapanainen H, Kontto J, Mannisto S. Chronotype differences in timing of energy and macronutrient intakes: A population-based study in adults. Obesity (Silver Spring). 2017 Mar;25(3):608-615. doi: 10.1002/oby.21747.
PubMed 28229553Patterson F, Malone SK, Lozano A, Grandner MA, Hanlon AL. Smoking, Screen-Based Sedentary Behavior, and Diet Associated with Habitual Sleep Duration and Chronotype: Data from the UK Biobank. Ann Behav Med. 2016 Oct;50(5):715-726. doi: 10.1007/s12160-016-9797-5.
PubMed 27056396Potter GD, Skene DJ, Arendt J, Cade JE, Grant PJ, Hardie LJ. Circadian Rhythm and Sleep Disruption: Causes, Metabolic Consequences, and Countermeasures. Endocr Rev. 2016 Dec;37(6):584-608. doi: 10.1210/er.2016-1083. Epub 2016 Oct 20.
PubMed 27763782Roenneberg T, Merrow M. The Circadian Clock and Human Health. Curr Biol. 2016 May 23;26(10):R432-43. doi: 10.1016/j.cub.2016.04.011.
PubMed 27218855Ruddick-Collins LC, Johnston JD, Morgan PJ, Johnstone AM. The Big Breakfast Study: Chrono-nutrition influence on energy expenditure and bodyweight. Nutr Bull. 2018 Jun;43(2):174-183. doi: 10.1111/nbu.12323. Epub 2018 May 8.
PubMed 29861661Sofi F, Dinu M, Pagliai G, Cesari F, Marcucci R, Casini A. Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial. Trials. 2016 May 4;17(1):233. doi: 10.1186/s13063-016-1353-x.
PubMed 27145958Sofi F, Dinu M, Pagliai G, Pierre F, Gueraud F, Bowman J, Gerard P, Longo V, Giovannelli L, Caderni G, de Filippo C. Fecal microbiome as determinant of the effect of diet on colorectal cancer risk: comparison of meat-based versus pesco-vegetarian diets (the MeaTIc study). Trials. 2019 Dec 9;20(1):688. doi: 10.1186/s13063-019-3801-x.
PubMed 31815647Dinu M, Lotti S, Pagliai G, Napoletano A, Asensi MT, Giangrandi I, Marcucci R, Amedei A, Colombini B, Sofi F. Effects of a chronotype-adapted diet on weight loss, cardiometabolic health, and gut microbiota: study protocol for a randomized controlled trial. Trials. 2024 Feb 28;25(1):152. doi: 10.1186/s13063-024-07996-z.
PubMed 38419068
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Chronotype: a Randomized Controlled Trial to Evaluate the Effects of a Chronotype-adapted Diet on Weight Loss in Overweight/Obese Subjects
- ClinicalTrials.gov ID
- NCT05941871
- Acronym / sponsor ID
- CHRONODIET / CHRONODIET
- Conditions
- Overweight and Obesity
- Keywords
- Chrono-nutrition, Circadian rhythms, Chronotype, Weight loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Mar 2025 (estimated)
- Study completion
- 6 Mar 2025 (estimated)
- First posted
- 12 Jul 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.
In humans, prolonged alterations in the circadian rhythm have been linked to cognitive impairments, premature ageing, and oncological and metabolic disorders such as diabetes and obesity. Obesity, in particular, is an ever-increasing condition with innumerable deleterious effects on human health. In recent years, studies have shown a relationship between a person's chronotype (morning or evening) and eating habits, as well as the importance of adapting these habits to physiological rhythms. Furthermore, it has been suggested that customising the caloric distribution of meals according to personal circadian rhythms may influence body weight and be one of the strategies to control overweight and obesity. In spite of the strong interest in this topic and the increasing number of observational studies conducted, there is currently a lack of intervention studies evaluating whether a low-calorie diet that takes into account the individual chronotype may be more effective than a standard low-calorie diet in the treatment of overweight and/or obesity.
Detailed description
Background
Society has changed enormously in recent decades and this has had a strong impact on the processes regulating circadian rhythms, in particular the sleep-wake and fasting-eating cycles. The 'normalisation' of the environment, favoured by technological progress, has in fact caused light pollution, noise pollution, excessive thermoregulation, continuous work shifts and disordered eating, leading to an uncoordinated circadian cycle with consequences on physical and mental balance. In humans, prolonged alterations of the biological clock have been linked to cognitive disorders, premature ageing, and oncological and metabolic diseases such as diabetes and obesity. Obesity, in particular, is a condition with innumerable negative effects on human health.
In recent years, a new branch of nutritional research has aroused growing interest in the scientific community: this is chrono-nutrition, which combines elements of nutritional research with elements of chronobiology and studies the impact of eating times on health. The first to use the term "chrono-dystrophy" as a chronic desynchronisation of circadian rhythms were Erren and colleagues, who in their work reported how a loss of synchronisation between environmental signals and physiological processes can lead to alterations in the communication between the central nervous system and peripheral clocks and a change in the subject's metabolism. Subsequently, numerous studies have evaluated the impact of the thirteen dimensions of eating behaviour - timing, frequency and regularity - on health, hypothesising a possible role of the individual circadian rhythm, or chronotype, on the risk of developing overweight and/or obesity. Recent data have demonstrated a relationship between a person's chronotype (morning or evening) and eating habits, as well as the importance of adapting these habits to physiological rhythms. Furthermore, it has been suggested that customising the caloric distribution of meals according to personal circadian rhythms may influence body weight and be one of the strategies to control overweight and obesity. Indeed, recent research has shown that calories ingested at different times of the day have different effects on energy utilisation, leading to differential weight loss, even in the presence of isocaloric quantities.
Despite the strong interest in this topic and the increasing number of observational studies conducted, there is currently a lack of intervention studies evaluating whether a dietary regimen can be used to control body weight. Evidence to date suggests that in order to increase the effectiveness of low-calorie diets, it may be of great interest to consider not only patients' daily energy expenditure but also their circadian preferences. Overall, chrono-nutrition could mediate the effects between sleep, diet and urbanisation, but further research is needed to elucidate the precise physiological and metabolic mechanisms underlying this phenomenon, the importance of chronotype for metabolic health and its impact on public health.
Objectives of the study
The objectives of the study are to compare the effects of a diet with a daily calorie distribution adapted to the individual chronotype with a control diet with a conventional daily calorie distribution. The primary outcome is weight change from baseline. Secondary outcomes are changes in body mass index (BMI), percentage of fat mass, biochemical parameters and gut microbiota profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised and controlled trial with 2 arms of intervention
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Dietary intervention - control groupGroup that will follow a low-calorie diet with a standard daily energy distribution for 4 months |
| Intervention | Experimental | Other: Dietary intervention - intervention groupGroup following a low-calorie diet with a different daily energy distribution according to their chronotype for 4 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- overweight or obese condition (BMI≥25 kg/m2)
- age between 18 and 65 years
- willing to give informes consent
Key exclusion criteria (5 listed)
- chronic illnesses or unstable conditions (e.g. cancer, kidney or liver disease, inflammatory-intestinal disease, cognitive decline, psychiatric disease)
- drug therapies (use of corticosteroids, antidiabetic drugs)
- pregnancy or intention to become pregnant in the next 12 months
- breastfeeding
- current or recent (last 3 months) adoption of a low-calorie diet
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 - intervention groupLow-calorie diet for 4 months with a different daily energy distribution according to the chronotype: * Morning chronotype: 50% of kcal administered before lunch and 15% in the second part of the day (specifically: 40% at breakfast, 10% in the morning snack, 35% at lunch, 5% at afternoon snack and 10% at dinner) * Evening chronotype: 15% of kcal given before lunch and 50% in the second half of the day (specifically: 10% of kcal at breakfast, 5% in the morning snack, 35% at lunch, 10% at snack time and 40% at dinner) | Other | Intervention |
| Dietary intervention - control groupGroup that will follow a low-calorie diet with a standard daily energy distribution (20% of kcal at breakfast, 10% in the morning snack, 35% at lunch, 10% at afternoon snack and 25% at dinner) for 4 months | Other | Control |
Primary outcome
Weight change
Time frame: 4 months
Measurement of body weight change from baseline in kg
14 secondary outcomes
Body mass index (BMI) changes
Time frame: 4 months
Fat mass changes
Time frame: 4 months
Fasting Blood Glucose changes
Time frame: 4 months
Total cholesterol changes
Time frame: 4 months
LDL-cholesterol changes
Time frame: 4 months
HDL-cholesterol changes
Time frame: 4 months
Triglycerides changes
Time frame: 4 months
Aspartate transaminase changes
Time frame: 4 months
Alanine transaminase changes
Time frame: 4 months
Gamma gamma-glutamyl transferase changes
Time frame: 4 months
Urea changes
Time frame: 4 months
Creatinine changes
Time frame: 4 months
Uric acid changes
Time frame: 4 months
Gut microbiota changes
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 30500869Almoosawi S, Vingeliene S, Gachon F, Voortman T, Palla L, Johnston JD, Van Dam RM, Darimont C, Karagounis LG. Chronotype: Implications for Epidemiologic Studies on Chrono-Nutrition and Cardiometabolic Health. Adv Nutr. 2019 Jan 1;10(1):30-42. doi: 10.1093/advances/nmy070.
- Background: PubMed 19215573Erren TC, Reiter RJ. Defining chronodisruption. J Pineal Res. 2009 Apr;46(3):245-7. doi: 10.1111/j.1600-079X.2009.00665.x. Epub 2009 Feb 9.
- Background: PubMed 1027738Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
- Background: PubMed 31153674Galindo Munoz JS, Gomez Gallego M, Diaz Soler I, Barbera Ortega MC, Martinez Caceres CM, Hernandez Morante JJ. Effect of a chronotype-adjusted diet on weight loss effectiveness: A randomized clinical trial. Clin Nutr. 2020 Apr;39(4):1041-1048. doi: 10.1016/j.clnu.2019.05.012. Epub 2019 May 21.
- 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.
- Background: PubMed 27246115Maukonen M, Kanerva N, Partonen T, Kronholm E, Konttinen H, Wennman H, Mannisto S. The associations between chronotype, a healthy diet and obesity. Chronobiol Int. 2016;33(8):972-81. doi: 10.1080/07420528.2016.1183022. Epub 2016 May 31.
- Background: PubMed 28229553Maukonen M, Kanerva N, Partonen T, Kronholm E, Tapanainen H, Kontto J, Mannisto S. Chronotype differences in timing of energy and macronutrient intakes: A population-based study in adults. Obesity (Silver Spring). 2017 Mar;25(3):608-615. doi: 10.1002/oby.21747.
- Background: PubMed 27056396Patterson F, Malone SK, Lozano A, Grandner MA, Hanlon AL. Smoking, Screen-Based Sedentary Behavior, and Diet Associated with Habitual Sleep Duration and Chronotype: Data from the UK Biobank. Ann Behav Med. 2016 Oct;50(5):715-726. doi: 10.1007/s12160-016-9797-5.
- Background: PubMed 27763782Potter GD, Skene DJ, Arendt J, Cade JE, Grant PJ, Hardie LJ. Circadian Rhythm and Sleep Disruption: Causes, Metabolic Consequences, and Countermeasures. Endocr Rev. 2016 Dec;37(6):584-608. doi: 10.1210/er.2016-1083. Epub 2016 Oct 20.
- Background: PubMed 27218855Roenneberg T, Merrow M. The Circadian Clock and Human Health. Curr Biol. 2016 May 23;26(10):R432-43. doi: 10.1016/j.cub.2016.04.011.
- Background: PubMed 29861661Ruddick-Collins LC, Johnston JD, Morgan PJ, Johnstone AM. The Big Breakfast Study: Chrono-nutrition influence on energy expenditure and bodyweight. Nutr Bull. 2018 Jun;43(2):174-183. doi: 10.1111/nbu.12323. Epub 2018 May 8.
- Background: PubMed 27145958Sofi F, Dinu M, Pagliai G, Cesari F, Marcucci R, Casini A. Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial. Trials. 2016 May 4;17(1):233. doi: 10.1186/s13063-016-1353-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.
Francesco Sofi, MD, PhD study director
Unit of Clinical Nutrition University Hospital of Careggi, Florence
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 - intervention group in people with Overweight and Obesity, 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 12 Jul 2023. 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?
Weight change (time frame: 4 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 NCT05941871, which also lists 14 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 12 Jul 2023.