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临床试验/NCT07630636
NCT07630636尚未招募不适用

Temporal Eating Patterns and Metabolic Health

Maria Chondronikola1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究者

发起方
Maria Chondronikola
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maria Chondronikola

Principal Inverstigator

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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