Chronotype-adapted Diet and Weight Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The objectives of the study are to compare the effects of a diet with a daily calorie distribution adapted to the individual chronotype with a control diet with a conventional daily calorie distribution. The primary outcome is weight change from baseline. Secondary outcomes are changes in body mass index (BMI), percentage of fat mass, biochemical parameters and gut microbiota profile.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Dietary intervention - intervention group
* Other: Dietary intervention - control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or obese condition (BMI≥25 kg/m2) age between 18 and 65 years willing to give informes consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised and controlled trial with 2 arms of intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Group that will follow a low-calorie diet with a standard daily energy distribution for 4 months | Other: Dietary intervention - control group<br>* Group that will follow a low-calorie diet with a standard daily energy distribution (20% of kcal at breakfast, 10% in the morning snack, 35% at lunch, 10% at afternoon snack and 25% at dinner) for 4 months<br>|
| Experimental: Intervention<br>Group following a low-calorie diet with a different daily energy distribution according to their chronotype for 4 months | Other: Dietary intervention - intervention group<br>* Low-calorie diet for 4 months with a different daily energy distribution according to the chronotype: Morning chronotype: 50% of kcal administered before lunch and 15% in the second part of the day (specifically: 40% at breakfast, 10% in the morning snack, 35% at lunch, 5% at afternoon snack and 10% at dinner) Evening chronotype: 15% of kcal given before lunch and 50% in the second half of the day (specifically: 10% of kcal at breakfast, 5% in the morning snack, 35% at lunch, 10% at snack time and 40% at dinner)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Measurement of body weight change from baseline in kg | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) changes | Measurement of BMI change from baseline. Weight and height will be combined to report BMI in kg/m^2 | 4 months | 
| Fat mass changes | Measurement of fat mass change from baseline. Percentage of fat mass will be assessed using the Akern bioelectrical impedance analyser (model SE 101) | 4 months | 
| Fasting Blood Glucose changes | Measurement of blood glucose concentration change from baseline in mg/dL | 4 months | 
| Total cholesterol changes | Measurement of total cholesterol change from baseline in mg/dL | 4 months | 
| LDL-cholesterol changes | Measurement of LDL cholesterol change from baseline in mg/dL | 4 months | 
| HDL-cholesterol changes | Measurement of HDL cholesterol change from baseline in mg/dL | 4 months | 
| Triglycerides changes | Measurement of triglycerides change from baseline in mg/dL | 4 months | 
| Aspartate transaminase changes | Measurement of aspartate transaminase change from baseline in U/l | 4 months | 
| Alanine transaminase changes | Measurement of alanine transaminase change from baseline in U/L | 4 months | 
| Gamma gamma-glutamyl transferase changes | Measurement of gamma-glutamyl transferase change from baseline in U/L | 4 months | 
| Urea changes | Measurement of urea change from baseline in mg/dL | 4 months | 
| Creatinine changes | Measurement of creatinin change from baseline in mg/dL | 4 months | 
| Uric acid changes | Measurement of uric acid change from baseline in mg/dL | 4 months | 
| Gut microbiota changes | Measurement of gut microbiota profile change from baseline. Each subject will be asked for a stool sample at the start of the study and at the end after 4 months in order to analyse the composition of the gut microbiota and short-chain fatty acids production | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chrono-nutrition, Circadian rhythms, Chronotype, Weight loss