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临床试验/NCT05941871
NCT05941871招募中不适用

Diet and Chronotype: a Randomized Controlled Trial to Evaluate the Effects of a Chronotype-adapted Diet on Weight Loss in Overweight/Obese Subjects

Azienda Ospedaliero-Universitaria Careggi2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Weight change

研究概览

简要总结

In humans, prolonged alterations in the circadian rhythm have been linked to cognitive impairments, premature ageing, and oncological and metabolic disorders such as diabetes and obesity. Obesity, in particular, is an ever-increasing condition with innumerable deleterious effects on human health. In recent years, studies have shown a relationship between a person's chronotype (morning or evening) and eating habits, as well as the importance of adapting these habits to physiological rhythms. Furthermore, it has been suggested that customising the caloric distribution of meals according to personal circadian rhythms may influence body weight and be one of the strategies to control overweight and obesity. In spite of the strong interest in this topic and the increasing number of observational studies conducted, there is currently a lack of intervention studies evaluating whether a low-calorie diet that takes into account the individual chronotype may be more effective than a standard low-calorie diet in the treatment of overweight and/or obesity.

详细描述

Background

Society has changed enormously in recent decades and this has had a strong impact on the processes regulating circadian rhythms, in particular the sleep-wake and fasting-eating cycles. The 'normalisation' of the environment, favoured by technological progress, has in fact caused light pollution, noise pollution, excessive thermoregulation, continuous work shifts and disordered eating, leading to an uncoordinated circadian cycle with consequences on physical and mental balance. In humans, prolonged alterations of the biological clock have been linked to cognitive disorders, premature ageing, and oncological and metabolic diseases such as diabetes and obesity. Obesity, in particular, is a condition with innumerable negative effects on human health.

In recent years, a new branch of nutritional research has aroused growing interest in the scientific community: this is chrono-nutrition, which combines elements of nutritional research with elements of chronobiology and studies the impact of eating times on health. The first to use the term "chrono-dystrophy" as a chronic desynchronisation of circadian rhythms were Erren and colleagues, who in their work reported how a loss of synchronisation between environmental signals and physiological processes can lead to alterations in the communication between the central nervous system and peripheral clocks and a change in the subject's metabolism. Subsequently, numerous studies have evaluated the impact of the thirteen dimensions of eating behaviour - timing, frequency and regularity - on health, hypothesising a possible role of the individual circadian rhythm, or chronotype, on the risk of developing overweight and/or obesity. Recent data have demonstrated a relationship between a person's chronotype (morning or evening) and eating habits, as well as the importance of adapting these habits to physiological rhythms. Furthermore, it has been suggested that customising the caloric distribution of meals according to personal circadian rhythms may influence body weight and be one of the strategies to control overweight and obesity. Indeed, recent research has shown that calories ingested at different times of the day have different effects on energy utilisation, leading to differential weight loss, even in the presence of isocaloric quantities.

Despite the strong interest in this topic and the increasing number of observational studies conducted, there is currently a lack of intervention studies evaluating whether a dietary regimen can be used to control body weight. Evidence to date suggests that in order to increase the effectiveness of low-calorie diets, it may be of great interest to consider not only patients' daily energy expenditure but also their circadian preferences. Overall, chrono-nutrition could mediate the effects between sleep, diet and urbanisation, but further research is needed to elucidate the precise physiological and metabolic mechanisms underlying this phenomenon, the importance of chronotype for metabolic health and its impact on public health.

Objectives of the study

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

盲法说明

In this trial blinding of experimenters will not be possible as they will have to administer the chronotype diet in the intervention group

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

  • overweight or obese condition (BMI≥25 kg/m2)
  • age between 18 and 65 years
  • willing to give informes consent

排除标准

  • chronic illnesses or unstable conditions (e.g. cancer, kidney or liver disease, inflammatory-intestinal disease, cognitive decline, psychiatric disease)
  • drug therapies (use of corticosteroids, antidiabetic drugs)
  • pregnancy or intention to become pregnant in the next 12 months
  • breastfeeding
  • current or recent (last 3 months) adoption of a low-calorie diet

结局指标

主要结局

Weight change

时间窗: 4 months

Measurement of body weight change from baseline in kg

次要结局

  • Body mass index (BMI) changes(4 months)
  • Aspartate transaminase changes(4 months)
  • Urea changes(4 months)
  • Uric acid changes(4 months)
  • HDL-cholesterol changes(4 months)
  • Triglycerides changes(4 months)
  • Alanine transaminase changes(4 months)
  • Gamma gamma-glutamyl transferase changes(4 months)
  • Total cholesterol changes(4 months)
  • Fat mass changes(4 months)
  • Fasting Blood Glucose changes(4 months)
  • LDL-cholesterol changes(4 months)
  • Creatinine changes(4 months)
  • Gut microbiota changes(4 months)

研究者

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

Francesco Sofi

Professor

Azienda Ospedaliero-Universitaria Careggi

研究点 (2)

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