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Temporal Eating Patterns and Metabolic Health (TIME-MET)

5 juin 2026 mis à jour par: Maria Chondronikola

Obesity and its related health problem, like fatty liver disease and type 2 diabetes, are major health problems worldwide and can lead to serious illness and reduced quality of life. Most advice focuses on eating fewer calories and increasing physical activity, but new research suggests that when we eat may also matter. Late meals can disrupt blood sugar control, how the body processes fat, and hormone balance. However, it is not fully understand how meal timing affects people who may be more at-risk. For example new mothers face disrupted sleep, which can lead to eating later in the day. People with fatty liver disease may have eating patterns that unintentionally worsen their condition.

To explore this, the study will include the following groups;

  1. First-time mothers in early motherhood, and women who do not have children.
  2. People with fatty liver disease along with people of similar age, sex, and weight who do not have the condition.

The aim of the study is to compare meal timing habits between these groups. All participants will complete a 3-day diet diary and a questionnaire about eating habits, sleep, lifestyle, and daily routines. Some participants may opt to complete an optional body composition check using a mobile app. A smaller subset of volunteers will take part in additional assessment, including a fasting blood sample, basic measurements (such as height, weight, and waist size), a body scan to measure fat and muscle. They will also wear a small device to track their blood sugar and another to monitor sleep and activity for 14 days. This study will increase the current understanding on how eating patterns and daily routines differ in these groups, and may help improve future advice on healthy lifestyles.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

400

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Royaume-Uni
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Royaume-Uni, CB2 0SL
        • Cambridge Clinical Research Centre
        • Contact:
        • Chercheur principal:
          • Maria Chondronikola, PhD, MS, MPH, RDN

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and women in early motherhood, recruited alongside matched control groups, from the NIHR BioResource cohort and community recruitment channels in the Cambridgeshire region, UK. A subset of participants will be recruited through the Institute of Metabolic Science at Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, for optional in-person assessments.

La description

Inclusion Criteria:

General (applied to all participants)

  • Willing and able to give informed consent for participation in the study and perform study assessments
  • Access to a smartphone or computer to complete digital questionnaires and dietary logs.

MASLD Cohort

  • Age 18-80
  • Confirmed self-reported MASLD diagnosis, irrespective of disease stage (cases)
  • Control group: Absence of confirmed MASLD diagnosis

Early Motherhood Cohort

  • Age 18-50
  • Women in early motherhood, defined as up to 12 months of their first successful childbirth delivery at enrolment
  • Control group: Women who have never given birth

Exclusion Criteria:

Adult participants may not enter the study if ANY of the following apply:

  • Self-reported active disease involving major organ dysfunction (except from Type 2 Diabetes Mellitus and Cardiovascular Disease for MASLD cohort)
  • Current smoking, heavy alcohol consumption (AUDIT score greater than 8 will be classified as heavy alcohol consumption), or recreational drug use
  • Current use of appetite-suppressant, appetite-stimulants, or weight-modifying pharmacotherapy (e.g., GLP-1 agonists, antidepressants, GIP agonists)
  • Recent unintentional rapid weight loss greater than 5% of body weight within the past 2 months, not attributable to recent pregnancy or intentional postpartum weight loss.
  • Current shift workers, defined as individuals working regular evening, night, rotating, or irregular schedules that disrupt standard sleep-wake cycles.
  • Currently pregnant or >1 year women after childbirth
  • Participants who cannot consent for themselves.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Women in early motherhood
Women aged 18-50, within one year of their first birth, enrolled to examine temporal eating patterns and metabolic health in early motherhood.
Adults with MASLD
Adults aged 18-80 with a confirmed self-reported diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), irrespective of disease stage, enrolled to examine the role of temporal eating patterns and metabolic health.
Adults without MASLD
Adults aged 18-80 without a confirmed MASLD diagnosis, matched to cases by age, sex, and body weight, enrolled to examine temporal eating patterns and metabolic health.
Nulliparous Women
Nulliparous women aged 18-50 with no history of childbirth, matched to postpartum participants by age and body weight, enrolled to examine temporal eating patterns and metabolic health.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Eating window duration across study groups
Délai: Single time point assessment over 3 non-consecutive days during study participation.
Characterisation and comparison of eating window duration between individuals with and without MASLD, and women in early motherhood compared to nulliparous women, derived from a 3-day dietary log completed via Intake24 over 3 non-consecutive days.
Single time point assessment over 3 non-consecutive days during study participation.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Caloric midpoint time across study groups
Délai: Single time point assessment over 3 non-consecutive days during study participation.
Characterise and compare the time at which 50% of the total daily caloric intake has been consumed between individuals with and without MASLD, and women in early motherhood compared to nulliparous women, derived from a 3-day dietary log completed via Intake24 over 3 non-consecutive days.
Single time point assessment over 3 non-consecutive days during study participation.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Meal frequency across study groups
Délai: Single time point assessment over 3 non-consecutive days during study participation.
Characterise and compare the number of eating occasions per day between individuals with and without MASLD, and women in early motherhood compared to nulliparous women, derived from a 3-day dietary log completed via Intake24 over 3 non-consecutive days.
Single time point assessment over 3 non-consecutive days during study participation.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Maria Chondronikola

Collaborateurs

Cambridge University Hospitals NHS Foundation Trust

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2029

Achèvement de l'étude (Estimé)

1 juin 2029

Dates d'inscription aux études

Première soumission

2 juin 2026

Première soumission répondant aux critères de contrôle qualité

2 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • University of Cambridge

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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