- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630636
Temporal Eating Patterns and Metabolic Health (TIME-MET)
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;
- 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.
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Chondronikola, PhD, MS, MPH, RDN
- Phone Number: +44-1223-746784
- Email: mc2425@medschl.cam.ac.edu
Study Locations
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0SL
- Cambridge Clinical Research Centre
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Contact:
- Krishna Chatterjee
- Phone Number: +44-1223-254800
- Email: tdw30@medschl.cam.ac.uk
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Principal Investigator:
- Maria Chondronikola, PhD, MS, MPH, RDN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eating window duration across study groups
Time Frame: Single time point assessment over 3 non-consecutive days during study participation.
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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.
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Single time point assessment over 3 non-consecutive days during study participation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Caloric midpoint time across study groups
Time Frame: Single time point assessment over 3 non-consecutive days during study participation.
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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.
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Single time point assessment over 3 non-consecutive days during study participation.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Meal frequency across study groups
Time Frame: Single time point assessment over 3 non-consecutive days during study participation.
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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.
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Single time point assessment over 3 non-consecutive days during study participation.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- University of Cambridge
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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