CClinicalTrials.gg
Not yet recruitingNCT07630636TIME-METUpdated Jun 8, 2026

Temporal Eating Patterns and Metabolic Health

An observational study in MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and Early Motherhood, sponsored by Maria Chondronikola. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Maria Chondronikola · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
  • Early Motherhood

Keywords

  • temporal eating patterns
  • MASLD
  • Early Motherhood
  • Metabolic dysfunction-Associated Steatotic Liver Disease
  • cross-sectional
  • metabolic health
  • chrononutrition
03

In context

Lead sponsor

This is the only study on the registry with Maria Chondronikola as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Caloric midpoint time across study groups

    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.

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

Other outcomes

  1. Meal frequency across study groups

    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.

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

07

Study locations

1 site
  • Cambridge Clinical Research Centre
    Cambridge, Cambridgeshire CB2 0SL, United Kingdom
    • Krishna Chatterjee · Contact · tdw30@medschl.cam.ac.uk · +44-1223-254800
    • Maria Chondronikola, PhD, MS, MPH, RDN · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07630636
Lead sponsor
Maria Chondronikola
Collaborators
Cambridge University Hospitals NHS Foundation Trust
Responsible party
Maria Chondronikola (Principal Inverstigator, Cambridge University Hospitals NHS Foundation Trust) — Sponsor-investigator
First posted
Jun 5, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2029 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Jun 8, 2026

Study contacts

Maria Chondronikola, PhD, MS, MPH, RDN
Contact
mc2425@medschl.cam.ac.edu
+44-1223-746784

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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