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NCT Number: NCT07630636

Temporal Eating Patterns and Metabolic Health

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cambridge Clinical Research Centre

Cambridge, Cambridgeshire, CB2 0SL, United Kingdom

Location contact

Krishna Chatterjee

CONTACT

[email protected]

+44-1223-254800

Maria Chondronikola, PhD, MS, MPH, RDN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Eating window duration across study groups

    Time frame: 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.

Secondary outcomes

  1. Caloric midpoint time across study groups

    Time frame: 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.

Other outcomes

  1. Meal frequency across study groups

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Chondronikola, PhD, MS, MPH, RDN

CONTACT

[email protected]

+44-1223-746784

Sponsors and collaborators

Lead sponsor

Maria Chondronikola

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

Registry information

Acronym: TIME-MET

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 5, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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