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Temporal Eating Patterns and Metabolic Health (TIME-MET)

2 giugno 2026 aggiornato da: 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, we still do 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, we are inviting the following two 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.

Our aim 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 help us better understand how eating patterns and daily routines differ in these groups, and may help improve future advice on healthy lifestyles.

Panoramica dello studio

Tipo di studio

Osservativo

Iscrizione (Stimato)

400

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Cambridgeshire
      • Cambridge, Cambridgeshire, Regno Unito, CB2 0SL
        • Cambridge Clinical Research Centre
        • Contatto:
        • Investigatore principale:
          • Maria Chondronikola, PhD, MS, MPH, RDN

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Eating window duration across study groups
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caloric midpoint time across study groups
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Meal frequency across study groups
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2029

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

2 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

5 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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