Chronotype-adapted Diet and Weight Loss (CHRONODIET)

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Dietary intervention - control group; Other: Dietary intervention - intervention group

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Sofi, MD, PhD; Phone Number: +390552758042; Email: francesco.sofi@unifi.it

Study Locations

• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Unit of Clinical Nutrition, University Hospital of Careggi
    • Contact: Francesco Sofi, Prof.; Phone Number: +390552758042; Email: francesco.sofi@unifi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Group that will follow a low-calorie diet with a standard daily energy distribution for 4 months	Other: Dietary intervention - control group; 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
Experimental: Intervention; Group following a low-calorie diet with a different daily energy distribution according to their chronotype for 4 months	Other: Dietary intervention - intervention group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Measurement of body weight change from baseline in kg	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI) changes	Measurement of BMI change from baseline. Weight and height will be combined to report BMI in kg/m^2	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)	4 months
Fasting Blood Glucose changes	Measurement of blood glucose concentration change from baseline in mg/dL	4 months
Total cholesterol changes	Measurement of total cholesterol change from baseline in mg/dL	4 months
LDL-cholesterol changes	Measurement of LDL cholesterol change from baseline in mg/dL	4 months
HDL-cholesterol changes	Measurement of HDL cholesterol change from baseline in mg/dL	4 months
Triglycerides changes	Measurement of triglycerides change from baseline in mg/dL	4 months
Aspartate transaminase changes	Measurement of aspartate transaminase change from baseline in U/l	4 months
Alanine transaminase changes	Measurement of alanine transaminase change from baseline in U/L	4 months
Gamma gamma-glutamyl transferase changes	Measurement of gamma-glutamyl transferase change from baseline in U/L	4 months
Urea changes	Measurement of urea change from baseline in mg/dL	4 months
Creatinine changes	Measurement of creatinin change from baseline in mg/dL	4 months
Uric acid changes	Measurement of uric acid change from baseline in mg/dL	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	4 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Study Director: Francesco Sofi, MD, PhD, Unit of Clinical Nutrition University Hospital of Careggi, Florence

Publications and helpful links

General Publications

• Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): March 6, 2025
• Study Completion (Estimated): March 6, 2025

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Weight loss; Circadian rhythms; Chronotype; Chrono-nutrition
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: CHRONODIET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No