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临床试验/NCT04850391
NCT04850391已完成不适用

Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
133
试验地点
2
主要终点
Change in Blood Pressure

研究概览

简要总结

The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.

详细描述

The data are fragmented and studies are focusing on interactions of sleep and obesity, eating pattern and obesity, or gut microbiota and obesity, but not the cross-talk of all these factors in the same individual or population. Therefore, we need a multifactorial approach to get a more deep insight on the obesity and weight regulation. Further, novel cost-effective tools to advance lifestyle changes are needed. Emerging evidence suggests that novel countermeasures, such as modulation of the timing of food intake, may be effective strategies in weight control and prevention of obesity. The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community dwelling 18 - 65 year old adults
  • BMI 18.5 - 30 kg/m2 (n = 40, M:F = 1:1)
  • BMI > 30 kg/m2 (n = 40, M:F = 1:1)
  • OSAS patients with BMI > 30 kg/m2 using nasal continuous positive airway pressure (CPAP) treatment on an average > 4 h/d (n = 40, M:F = 1:1).

排除标准

  • Antimicrobial treatment within 3 months prior the baseline visit
  • Inflammatory bowel diseases

结局指标

主要结局

Change in Blood Pressure

时间窗: 2 years

Change in Blood Pressure

GHbA1c

时间窗: 2 years

Change in GHbA1c

Timing of eating

时间窗: 2 years

Change in timing of eating

Subjective sleep quality (Pittsburg Sleep Quality Index)

时间窗: 2 years

Changes in subjective sleep quality

Weight

时间窗: 2 years

Changes in weight

Excessive daytime sleepiness (Epworth Sleepiness Scale)

时间窗: 2 years

Change in excessive daytime sleepiness

Waist/Hip ratio

时间窗: 2 years

Changes in Waist/Hip ratio

Gut microbiota

时间窗: 2 years

Changes in gut microbiota (species, proportions of different species)

Mood (DEPS questionnaire)

时间窗: 2 years

Changes in mood

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tarja Saaresranta

Principal Investigator

Turku University Hospital

研究点 (2)

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