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临床试验/NCT03147703
NCT03147703已完成不适用

Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota in a Mediterranean Population

Universidad de Murcia2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年6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
10
试验地点
2
主要终点
Feces microbiome daily rhythms

研究概览

简要总结

The purpose of this investigation is to test the hypothesis that in humans, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less responsiveness to dietary treatments profile. These changes in microbiota may partly explain the weight loss difficulties that characterized late eaters in previous studies. Thus, the aim is to analyze the effect of the timing of food intake in humans' saliva microbiome daily rhythms in a randomized, crossover interventional study, in order to achieve.

详细描述

Overweight and obesity can currently be considered a major threat to human health. Recent studies suggest that not only "what" we eat, but also "when" we eat may have a significant role in obesity treatment. The importance of caloric distribution across the day on weight loss therapy was supported by a 12-weeks experimental study showing that subjects assigned to high caloric intake during breakfast lost significantly more weight than those assigned to high caloric intake during the dinner. These results suggest that eating late may affect obesity and impair the success of weight loss therapies.

Novel evidence from animal and human studies indicates that the composition of the gut microbiota may also be involved in obesity and weight loss. Moreover, studies performed in extreme obese subjects have demonstrated that weight loss improves the obesity-associated gut microbiota composition towards a lean microbiome phenotype.

A recent study has shown that the timing of food intake influences microbiota in mice model. This study reported that obesity dampens the cyclical changes in the gut microbiome of mice while time-restricted feeding (TRF), in which feeding is consolidated to the nocturnal phase, partially restores these cyclical fluctuations. Furthermore, TRF which protects against obesity and metabolic diseases affects bacteria and has shown to influence host metabolism. Then, feeding pattern and time of food intake, in addition to diet, are important parameters when assessing the microbiome's contribution to mice metabolism. However, to our knowledge no human studies are available showing the effect of timing of food intake in microbiota.

Thus, the aim was to analyze the effect of the timing of food intake in humans' saliva microbiome, in order to achieve a better understanding of the relationship between food timing, obesity and weight loss in humans.

This goal will be achieved through a specific approach:

研究设计

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

入排标准

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

入选标准

  • Healthy women
  • Body Mass Index: 20 to 30 kg/m2
  • Caucasian
  • Day workers

排除标准

  • Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders
  • Receiving any pharmacologic treatment other than oral contraceptives
  • Bulimia diagnosis, prone to binge eating
  • Pregnancy

结局指标

主要结局

Feces microbiome daily rhythms

时间窗: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.

Investigators will assess gut microbiome with one feces sample at early eating and late eating visits.

Saliva microbiome daily rhythms

时间窗: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.

Investigators will measure daily rhythms of saliva microbiome at early eating and late eating visits.

次要结局

未报告次要终点

研究者

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

PROF. MARTA GARAULET AZA

Full profesor

Universidad de Murcia

研究点 (2)

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