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临床试验/NCT04618133
NCT04618133已完成不适用

Time-restricted Eating to Improve Body Fat Mass in Overweight and Obese Individuals with Morning Chronotype: a Randomized, Open-label, Multi-arm Trial

Tinh-Hai Collet, MD2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Change in body fat mass

研究概览

简要总结

Overweight and obesity are highly prevalent conditions worldwide, despite active research of new interventions over decades. Current interventions include medications or bariatric surgery, but these approaches cannot be used in all patients and require clear indications and a close multidisciplinary management. Therefore most patients and physicians rely on lifestyle interventions, focusing on a balanced diet and physical exercise.

Recent studies have uncovered that energy metabolism is also regulated by circadian rhythms, which depend on spontaneous diurnal oscillations of the central clock, retinal sensing of ambient light, and daily feeding-fasting cycles. The chronotype has an influence on behavioral patterns, where some people describe that they are more alert in the morning or in the evening: The morning or evening chronotypes, respectively. However, in modern societies, many people are exposed to external cues in misalignment with their circadians clocks. The mismatch between the individual chronotype and the social/work life can lead to metabolic disorders.

Time-restricted eating (TRE), i.e. energy intake limited to certain windows of time without restricting calories, is an appealing approach because it proposes to realign the circadian clocks with external cues provided by the timing of food intake, thus leading to better metabolic outcomes.

The investigators speculate that the TRE intervention needs to be personalized to reach efficacy in a broader population. To tailor the TRE intervention to each individual and harmonize their eating patterns in accordance to their chronotype, the investigators plan to test early TRE vs. late TRE vs. active control in overweight and obese individuals with morning chronotype.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical criteria
  • Men and premenopausal women
  • Age 25-50 years
  • BMI 25-34 kg/m2
  • Stable weight (maximum ± 2 kg of usual body weight) over the previous 3 months
  • Stable body fat mass (maximum ± 1 kg of body fat mass) during the run-in phase
  • Eating window ≥ 12 hours during the run-in phase
  • Morning chronotype
  • Work-related criteria
  • Daytime work at least 3 days per week over the previous 1 month and planned during the study
  • Study-related criteria
  • Able to give informed consent and follow the study procedures for the entire duration
  • Confident use of a smartphone and able to take regular pictures of food/drinks

排除标准

  • Clinical criteria
  • Pregnant and breastfeeding women, plans for maternity during the study
  • On a diet, intermittent fasting, in a weight management program over the previous 3 months or planned during the study
  • Eating disorder(s) or prior bariatric surgery
  • Diabetes with hypoglycemic drug(s)
  • Major illness/fever over the previous 1 month
  • Active major cardiovascular, respiratory, liver, gastrointestinal, renal, neurological or endocrine disorders
  • Coagulation disorder, on anticoagulant drug, skin disorder affecting wound healing
  • Active cancer and/or oncologic treatment over the previous 12 months
  • Major sleep disorder (including untreated sleep apnea syndrome), major mental illness
  • Consumption of > 7 standard units of alcohol per week for women and > 14 standard units of alcohol per week for men
  • Work and time-related criteria
  • Shift work, such as evening shifts or night shifts, over the previous 1 month or planned during the study
  • Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 1 month or planned during the study
  • Study-related criteria and other interventions
  • Enrolled in another interventional clinical trial (medication, medical device) over the previous 1 month and planned during the study
  • Regular medications over the previous 1 month that could affect the study endpoints (e.g. centrally acting, medications affecting gut absorption, transit or weight, hypoglycemic drug, hormonal treatment...)

结局指标

主要结局

Change in body fat mass

时间窗: From randomization visit to close-out visit (12 weeks)

As measured by dual-energy x-rax absorptiometry (DXA)

次要结局

  • Change in ambient light(From randomization visit to close-out visit (12 weeks))
  • Change in sleep quality(From randomization visit to close-out visit (12 weeks))
  • Change in eating duration(From randomization visit to close-out visit (12 weeks))
  • Change in sleep/wake cycles(From randomization visit to close-out visit (12 weeks))
  • Change in calorie intake over the 24-hour cycle(From randomization visit to close-out visit (12 weeks))
  • Change in weight(From randomization visit to close-out visit (12 weeks))
  • Change in waist circumference(From randomization visit to close-out visit (12 weeks))
  • Change in systolic and diastolic blood pressure(From randomization visit to close-out visit (12 weeks))
  • Change in body fat mass(From randomization visit to close-out visit (12 weeks))
  • Change in fat-free mass(From randomization visit to close-out visit (12 weeks))
  • Change in physical activity(From randomization visit to close-out visit (12 weeks))
  • Change in fasting glucose(From randomization visit to close-out visit (12 weeks))
  • Change in lean body mass(From randomization visit to close-out visit (12 weeks))
  • Change in hip circumference(From randomization visit to close-out visit (12 weeks))
  • Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)(From randomization visit to close-out visit (12 weeks))
  • Change in glucose excursion(From randomization visit to close-out visit (12 weeks))
  • Change in resting energy expenditure(From randomization visit to close-out visit (12 weeks))
  • Incidence of adverse events in response to the randomized intervention(From randomization visit to close-out visit (12 weeks))

研究者

发起方
Tinh-Hai Collet, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tinh-Hai Collet, MD

Principal Investigator

University Hospital, Geneva

研究点 (2)

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