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临床试验/ISRCTN32122407
ISRCTN32122407进行中(未招募)未知

Early versus late time-restricted feeding: its effect on metabolic disease risk factors in adults at increased risk of developing type 2 diabetes

niversity of Surrey0 个研究点目标入组 51 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
51

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Participants must:
  • 1. Be aged 18 – 65 years old
  • 2. Have a BMI = 25 kg/m2
  • 3. Have maintained a stable body weight for the 6 months preceding the study (± 2 kg)
  • 4. Be at increased/moderate/high risk of developing type 2 diabetes, as per the Diabetes UK Diabetes Risk Score (scoring = 7)
  • 5. Be able and willing to give informed oral and informed written consent
  • 6. Complete and meet the defined criteria of pre-study questionnaires
  • 7. Be able and willing to complete daily sleep and food diaries during the study
  • 8. Have an eating period of = 12 hours a day
  • 9. Agree to eat their meals within certain time periods during the day whilst participating in the study
  • 10. Be willing and able to undertake laboratory tests on agreed dates during the study

排除标准

  • Participants will be excluded if they:
  • 1. Have a specific medical condition as confirmed by pre-study questionnaires – Type 1 or 2 diabetes, Polycystic Ovary Syndrome (PCOS), Schizophrenia, Bipolar illness, Depression or receiving treatment with antipsychotic medication, or have a history of Cardiovascular Disease (myocardial infarction or stroke)
  • 2. Are currently on certain medications: weight loss, glucose- or lipid-lowering medication (e.g. ‘Metformin’ or ‘Statins’), hypnotics or melatonin supplements
  • 3. Are a smoker
  • 4. Are pregnant
  • 5. Have a history of any circadian or sleep disorder as confirmed by pre-study questionnaires
  • 6. Have habitual irregular sleep patterns on more than 2 nights per week (bed time outside 22:00-1:00 h and wake up time outside 6:00-9:00 h) or a sleep duration on more than 2 nights per week < 7 or > 9 hours
  • 7. Have donated over 400 ml of blood in the three months preceding the study
  • 8. Exceed the defined criteria of pre-study questionnaires:
  • 8.1. BMI: < 25kg/m2
  • 8.2. 30 = Horne-Östberg questionnaire =70
  • 8.3. Pittsburgh Sleep Quality Index: > 5
  • 8.4. Epworth Sleepiness Scale > 9
  • 9. Have travelled across more than two time zones within a month before or during the study
  • 10. Are currently taking part in a clinical trial or another research study or have taken part within the last 3 months
  • 11. Have participated in rotating or night shift work for more than 6 months prior to or during the study

研究者

发起方
niversity of Surrey

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