- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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, 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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Maria Chondronikola, PhD, MS, MPH, RDN
- Numer telefonu: +44-1223-746784
- E-mail: mc2425@medschl.cam.ac.edu
Lokalizacje studiów
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Cambridgeshire
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Cambridge, Cambridgeshire, Zjednoczone Królestwo, CB2 0SL
- Cambridge Clinical Research Centre
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Kontakt:
- Krishna Chatterjee
- Numer telefonu: +44-1223-254800
- E-mail: tdw30@medschl.cam.ac.uk
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Główny śledczy:
- Maria Chondronikola, PhD, MS, MPH, RDN
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Eating window duration across study groups
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Caloric midpoint time across study groups
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Meal frequency across study groups
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- University of Cambridge
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Wczesne macierzyństwo
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Western University, CanadaJeszcze nie rekrutacjaeTRE (Early Time Restricted Eating) z BCAA | eTRE (ograniczone wczesne jedzenie)Kanada
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Mathematica Policy Research, Inc.Boston Children's Hospital; Department of Health and Human ServicesJeszcze nie rekrutacjaWczesna interwencja, edukacja (dostęp i uczestnictwo w programie Head Start i Early Head Start)Stany Zjednoczone