Clinical trial NCT06588088: Cardiorenal and Metabolic Effects of Nighttime Eating
Official title: Cardiorenal, Metabolic and Circadian Effects of Nighttime Eating
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Night Eating Syndrome
Metabolic Syndrome
Cardiorenal Syndrome
Sleep Disorder
Keywords: Night Eating Syndrome
Nutrition
Metabolic Syndrome
Lead sponsor: Koc University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Nutritional study with a single-arm cross-over design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the investigators are trying to find out of the effect of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders.

Detailed description: The Coronavirus Disease (COVID)-19 pandemic, which emerged in recent years, has deeply affected living conditions and has had an impact on societies on eating habits. As shown by some studies, it has been shown that night sleep habits have changed and night nutrition and calorie intake have increased due to reasons related to staying at home, working remotely, and isolation during the pandemic period. However, some recent studies have shown a relationship between nighttime eating and conditions that predispose to metabolic syndrome, such as obesity and hyperglycemia. At the same time, prospective studies on the details of the cardiorenal and metabolic effects of night feeding behavior, which is one of the important predisposing factors for metabolic syndrome, are quite insufficient. Although the importance of nighttime eating habits has begun to be emphasized in recent years with recent randomized cross-controlled studies on this subject, there are not yet enough prospective studies on this subject. In this respect, studies on nighttime eating behavior, which is common in society, are important.In this study, a cross-over design study was conducted on the effectiveness of nighttime eating on metabolism, cardiorenal, hormonal and circadian rhythm, and a study was conducted to examine the effects of diseases that are quite common in internal medicine practice, such as type 2 diabetes mellitus, chronic kidney disease, hypertension, metabolic syndrome and sleep disorders. The investigators aim to create a new and additional perspective on the management, treatment and follow-up of common diseases and to contribute to raising awareness about night nutrition.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Being willing to adapt to the desired feeding time and calories
* Body mass index (BMI) is between 18-30
* Not having any systemic disease, not using chronic medication

Exclusion Criteria:

* -\<18, \>65 years old
* Failure to comply with the regulated nutrition program
* BMI between \<18 and \>30
* Presence of systemic disease: E.g. Diabetes Mellitus, Chronic Kidney Disease, Coronary Artery Disease, Hypertension etc.
* Inability to have polygraphy
* Chronic drug use

Primary outcomes:
measure: Change of the concentration albuminuria in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of the concentration of serum melatonin levels in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of the concentration of serum leptin levels in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of the concentration of serum total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride levels in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of Concentration of serum glucose in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of Concentration of serum insulin in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of concentration of serum Cortisol Level in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of concentration of serum Fibroblast Growth Factor 21 Level in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of the concentration of serum Cytokeratin 18 level in the Nighttime Eating Period
timeFrame: 1 week
measure: Change of value of Apnea Hypopnea Index in the Nighttime Eating Period
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University Hospital
Study officials:
affiliation: Koc University, School Of Medicine
name: Mehmet Kanbay, Medical Doctor
role: STUDY_DIRECTOR
References: