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
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