MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)TIME-METNCT07630636
Temporal Eating Patterns and Metabolic Health
An observational study of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and Early Motherhood, run by Maria Chondronikola at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Early Motherhood
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Cambridge Clinical Research Centre
Cambridge, Cambridgeshire, CB2 0SL
Krishna Chatterjee, +44-1223-254800, tdw30@medschl.cam.ac.uk
Maria Chondronikola, PhD, MS, MPH, RDN
About this study
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;
Read more
- First-time mothers in early motherhood, and women who do not have children.
- 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.
- Keywords
- temporal eating patterns, MASLD, Early Motherhood, Metabolic dysfunction-Associated Steatotic Liver Disease, cross-sectional, metabolic health, chrononutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Single time point assessment over 3 non-consecutive days during study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Chondronikola
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Maria Chondronikola, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630636
- Sponsor's protocol ID
- University of Cambridge
- Acronym
- TIME-MET
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Eating Patterns and Metabolic Health
- ClinicalTrials.gov ID
- NCT07630636
- Acronym / sponsor ID
- TIME-MET / University of Cambridge
- Keywords
- temporal eating patterns, MASLD, Early Motherhood, Metabolic dysfunction-Associated Steatotic Liver Disease, cross-sectional, metabolic health, chrononutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Maria ChondronikolaUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- First-time mothers in early motherhood, and women who do not have children.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Caloric midpoint time across study groups
Time frame: Single time point assessment over 3 non-consecutive days during study participation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and Early Motherhood, run by Maria Chondronikola at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Chondronikola, PhD, MS, MPH, RDN (+44-1223-746784, mc2425@medschl.cam.ac.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating window duration across study groups (time frame: Single time point assessment over 3 non-consecutive days during study participation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.