NCT05174871进行中（未招募）不适用
Time-Restricted Feeding in Children and Adolescents With Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change in BMI z score
研究概览
简要总结
This study will evaluate the effectiveness of a 2-month time-restricted feeding (TRF) intervention in children and adolescents with obesity. The investigators will determine whether the potential beneficial effects of the intervention in this population are maintained over time. Furthermore, potential mechanisms mediating TRF effects will be explored, specifically focusing on the potential role of the gut microbiome and the circadian rhythm.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity (BMI z score > 2)
排除标准
- •Bariatric surgery
- •Spontaneous time-restricted feeding for > 12 hours
- •Diabetes with insulin treatment
- •Pregnancy
- •Intellectual disability
- •Under drug treatment with a prescription change in the last 3 months
结局指标
主要结局
Change in BMI z score
时间窗: Baseline, 2 months
Weight and height will be combined to calculate BMI. The World Health Organization growth charts will be used to calculate BMI z scores.
次要结局
- Change in BMI z score (follow-up)(1 year, 2 year)
- Change in lipid profile(Baseline, 2 months, 1 year, 2 year)
- Change in dietary composition(Baseline, 2 months, 1 year, 2 year)
- Change in blood pressure(Baseline, 2 months, 1 year, 2 year)
- Change in glucose metabolism(Baseline, 2 months, 1 year, 2 year)
- Change in Adiposity(Baseline, 2 months, 1 year, 2 year)
研究者
研究点 (1)
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