Cardiorenal and Metabolic Effects of Nighttime Eating
- Conditions
- Night Eating SyndromeMetabolic SyndromeCardiorenal SyndromeSleep Disorder
- Interventions
- Other: Dietary
- Registration Number
- NCT06588088
- Lead Sponsor
- Koc University Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 16
- 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
- -<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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Early eaters Dietary The diet of these healthy volunteers was such that no calories were consumed after 19.30 in the evening in the first week of the study. Night time Eaters Dietary The diet of the same healthy volunteers was 25% of the daily calorie need calculated according to the Harris - Benedict formula was taken, taking into account the night time eating syndrome (NES) criteria, after 20.30 in the evening.
- Primary Outcome Measures
Name Time Method Change of the concentration albuminuria in the Nighttime Eating Period 1 week More than 20% increase during night feeding period
Change of the concentration of serum melatonin levels in the Nighttime Eating Period 1 week More than 50% increase during night feeding period
Change of the concentration of serum leptin levels in the Nighttime Eating Period 1 week More than 50% increase during night feeding period
Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period 1 week More than 50% increase during night feeding period
Change of the concentration of serum total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride levels in the Nighttime Eating Period 1 week More than 20% increase during night feeding period
Change of Concentration of serum glucose in the Nighttime Eating Period 1 week More than 10% increase during night feeding period
Change of Concentration of serum insulin in the Nighttime Eating Period 1 week More than 10% increase during night feeding period
Change of concentration of serum Cortisol Level in the Nighttime Eating Period 1 week More than 50% increase during night feeding period
Change of concentration of serum Fibroblast Growth Factor 21 Level in the Nighttime Eating Period 1 week More than 10% increase during night feeding period
Change of the concentration of serum Cytokeratin 18 level in the Nighttime Eating Period 1 week More than 10% increase during night feeding period
Change of value of Apnea Hypopnea Index in the Nighttime Eating Period 1 week The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation to be considered. Combining AHI and oxygen desaturation gives an overall sleep apnea severity score that evaluates both the number of sleep breathing disruptions and the degree of oxygen desaturation (low oxygen level in the blood) during said disruptions.
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as:
Normal: AHI\<5 Mild sleep apnea: 5≤AHI\<15 Moderate sleep apnea: 15≤AHI\<30 Severe sleep apnea: AHI≥30More than 10% increase during night feeding period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Koc University Hospital
🇹🇷Istanbul, Turkey