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, 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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Maria Chondronikola, PhD, MS, MPH, RDN
- Telefonnummer: +44-1223-746784
- E-post: mc2425@medschl.cam.ac.edu
Studiesteder
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Cambridgeshire
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Cambridge, Cambridgeshire, Storbritannia, CB2 0SL
- Cambridge Clinical Research Centre
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Ta kontakt med:
- Krishna Chatterjee
- Telefonnummer: +44-1223-254800
- E-post: tdw30@medschl.cam.ac.uk
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Hovedetterforsker:
- Maria Chondronikola, PhD, MS, MPH, RDN
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Eating window duration across study groups
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Caloric midpoint time across study groups
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Meal frequency across study groups
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- University of Cambridge
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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