NCT05941871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

May 18, 2023

Last Update Submit

July 4, 2023

Conditions

Overweight and Obesity

Keywords

Chrono-nutritionCircadian rhythmsChronotypeWeight loss

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Measurement of body weight change from baseline in kg

    4 months

Secondary Outcomes (14)

  • Body mass index (BMI) changes

    4 months

  • Fat mass changes

    4 months

  • Fasting Blood Glucose changes

    4 months

  • Total cholesterol changes

    4 months

  • LDL-cholesterol changes

    4 months

  • +9 more secondary outcomes

Study Arms (2)

Control

EXPERIMENTAL

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

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

Other: Dietary intervention - intervention group

Interventions

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)

Intervention
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

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Clinical Nutrition, University Hospital of Careggi

Florence, 50134, Italy

RECRUITING

Related Publications (14)

  • 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.

    PMID: 30500869BACKGROUND

  • 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.

    PMID: 19215573BACKGROUND

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

    PMID: 1027738BACKGROUND

  • 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.

    PMID: 31153674BACKGROUND

  • Lotti S, Pagliai G, Colombini B, Sofi F, Dinu M. Chronotype Differences in Energy Intake, Cardiometabolic Risk Parameters, Cancer, and Depression: A Systematic Review with Meta-Analysis of Observational Studies. Adv Nutr. 2022 Feb 1;13(1):269-281. doi: 10.1093/advances/nmab115.

    PMID: 34549270BACKGROUND

  • 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.

    PMID: 27246115BACKGROUND

  • 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.

    PMID: 28229553BACKGROUND

  • 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.

    PMID: 27056396BACKGROUND

  • 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.

    PMID: 27763782BACKGROUND

  • 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.

    PMID: 27218855BACKGROUND

  • 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.

    PMID: 29861661BACKGROUND

  • 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.

    PMID: 27145958BACKGROUND

  • 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.

    PMID: 31815647BACKGROUND

  • Dinu 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.

    PMID: 38419068DERIVED

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Francesco Sofi, MD, PhD

    Unit of Clinical Nutrition University Hospital of Careggi, Florence

    STUDY DIRECTOR

Central Study Contacts

Francesco Sofi, MD, PhD

CONTACT

+390552758042francesco.sofi@unifi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
In this trial blinding of experimenters will not be possible as they will have to administer the chronotype diet in the intervention group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised and controlled trial with 2 arms of intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2023

First Posted

July 12, 2023

Study Start

March 6, 2023

Primary Completion

March 6, 2025

Study Completion

March 6, 2025

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

IT(1)