search
Back to results

Chronotype-adapted Diet and Weight Loss (CHRONODIET)

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dietary intervention - intervention group
Dietary intervention - control group
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Chrono-nutrition, Circadian rhythms, Chronotype, Weight loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: overweight or obese condition (BMI≥25 kg/m2) age between 18 and 65 years willing to give informes consent Exclusion Criteria: 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

Sites / Locations

  • Unit of Clinical Nutrition, University Hospital of CareggiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Intervention

Arm Description

Group that will follow a low-calorie diet with a standard daily energy distribution for 4 months

Group following a low-calorie diet with a different daily energy distribution according to their chronotype for 4 months

Outcomes

Primary Outcome Measures

Weight change
Measurement of body weight change from baseline in kg

Secondary Outcome Measures

Body mass index (BMI) changes
Measurement of BMI change from baseline. Weight and height will be combined to report BMI in kg/m^2
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)
Fasting Blood Glucose changes
Measurement of blood glucose concentration change from baseline in mg/dL
Total cholesterol changes
Measurement of total cholesterol change from baseline in mg/dL
LDL-cholesterol changes
Measurement of LDL cholesterol change from baseline in mg/dL
HDL-cholesterol changes
Measurement of HDL cholesterol change from baseline in mg/dL
Triglycerides changes
Measurement of triglycerides change from baseline in mg/dL
Aspartate transaminase changes
Measurement of aspartate transaminase change from baseline in U/l
Alanine transaminase changes
Measurement of alanine transaminase change from baseline in U/L
Gamma gamma-glutamyl transferase changes
Measurement of gamma-glutamyl transferase change from baseline in U/L
Urea changes
Measurement of urea change from baseline in mg/dL
Creatinine changes
Measurement of creatinin change from baseline in mg/dL
Uric acid changes
Measurement of uric acid change from baseline in mg/dL
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

Full Information

First Posted
May 18, 2023
Last Updated
July 4, 2023
Sponsor
Azienda Ospedaliero-Universitaria Careggi
search

1. Study Identification

Unique Protocol Identification Number
NCT05941871
Brief Title
Chronotype-adapted Diet and Weight Loss
Acronym
CHRONODIET
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
March 6, 2025 (Anticipated)
Study Completion Date
March 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Chrono-nutrition, Circadian rhythms, Chronotype, Weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised and controlled trial with 2 arms of intervention
Masking
None (Open Label)
Masking Description
In this trial blinding of experimenters will not be possible as they will have to administer the chronotype diet in the intervention group
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Group that will follow a low-calorie diet with a standard daily energy distribution for 4 months
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Group following a low-calorie diet with a different daily energy distribution according to their chronotype for 4 months
Intervention Type
Other
Intervention Name(s)
Dietary intervention - intervention group
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Dietary intervention - control group
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight change
Description
Measurement of body weight change from baseline in kg
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Body mass index (BMI) changes
Description
Measurement of BMI change from baseline. Weight and height will be combined to report BMI in kg/m^2
Time Frame
4 months
Title
Fat mass changes
Description
Measurement of fat mass change from baseline. Percentage of fat mass will be assessed using the Akern bioelectrical impedance analyser (model SE 101)
Time Frame
4 months
Title
Fasting Blood Glucose changes
Description
Measurement of blood glucose concentration change from baseline in mg/dL
Time Frame
4 months
Title
Total cholesterol changes
Description
Measurement of total cholesterol change from baseline in mg/dL
Time Frame
4 months
Title
LDL-cholesterol changes
Description
Measurement of LDL cholesterol change from baseline in mg/dL
Time Frame
4 months
Title
HDL-cholesterol changes
Description
Measurement of HDL cholesterol change from baseline in mg/dL
Time Frame
4 months
Title
Triglycerides changes
Description
Measurement of triglycerides change from baseline in mg/dL
Time Frame
4 months
Title
Aspartate transaminase changes
Description
Measurement of aspartate transaminase change from baseline in U/l
Time Frame
4 months
Title
Alanine transaminase changes
Description
Measurement of alanine transaminase change from baseline in U/L
Time Frame
4 months
Title
Gamma gamma-glutamyl transferase changes
Description
Measurement of gamma-glutamyl transferase change from baseline in U/L
Time Frame
4 months
Title
Urea changes
Description
Measurement of urea change from baseline in mg/dL
Time Frame
4 months
Title
Creatinine changes
Description
Measurement of creatinin change from baseline in mg/dL
Time Frame
4 months
Title
Uric acid changes
Description
Measurement of uric acid change from baseline in mg/dL
Time Frame
4 months
Title
Gut microbiota changes
Description
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
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: overweight or obese condition (BMI≥25 kg/m2) age between 18 and 65 years willing to give informes consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Sofi, MD, PhD
Phone
+390552758042
Email
francesco.sofi@unifi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Sofi, MD, PhD
Organizational Affiliation
Unit of Clinical Nutrition University Hospital of Careggi, Florence
Official's Role
Study Director
Facility Information:
Facility Name
Unit of Clinical Nutrition, University Hospital of Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Sofi, Prof.
Phone
+390552758042
Email
francesco.sofi@unifi.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30500869
Citation
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.
Results Reference
background
PubMed Identifier
19215573
Citation
Erren 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.
Results Reference
background
PubMed Identifier
1027738
Citation
Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
Results Reference
background
PubMed Identifier
31153674
Citation
Galindo 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.
Results Reference
background
PubMed Identifier
34549270
Citation
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.
Results Reference
background
PubMed Identifier
27246115
Citation
Maukonen 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.
Results Reference
background
PubMed Identifier
28229553
Citation
Maukonen 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.
Results Reference
background
PubMed Identifier
27056396
Citation
Patterson 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.
Results Reference
background
PubMed Identifier
27763782
Citation
Potter 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.
Results Reference
background
PubMed Identifier
27218855
Citation
Roenneberg 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.
Results Reference
background
PubMed Identifier
29861661
Citation
Ruddick-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.
Results Reference
background
PubMed Identifier
27145958
Citation
Sofi 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. Erratum In: Trials. 2016;17(1):253.
Results Reference
background
PubMed Identifier
31815647
Citation
Sofi 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.
Results Reference
background

Learn more about this trial

Chronotype-adapted Diet and Weight Loss

We'll reach out to this number within 24 hrs