NCT07630636

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Jun 2029

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

June 2, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

temporal eating patternsMASLDEarly MotherhoodMetabolic dysfunction-Associated Steatotic Liver Diseasecross-sectionalmetabolic healthchrononutrition

Outcome Measures

Primary Outcomes (1)

  • Eating window duration across study groups

    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.

Secondary Outcomes (1)

  • Caloric midpoint time across study groups

    Single time point assessment over 3 non-consecutive days during study participation.

Other Outcomes (1)

  • Meal frequency across study groups

    Single time point assessment over 3 non-consecutive days during study participation.

Study Arms (4)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Clinical Research Centre

Cambridge, Cambridgeshire, CB2 0SL, United Kingdom

Location

Central Study Contacts

Maria Chondronikola, PhD, MS, MPH, RDN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Inverstigator

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 5, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations