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Cardiorenal and Metabolic Effects of Nighttime Eating

Cardiorenal, Metabolic and Circadian Effects of Nighttime Eating

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06588088
Enrollment
16
Registered
2024-09-19
Start date
2022-05-01
Completion date
2024-12-01
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiorenal Syndrome, Metabolic Syndrome, Night Eating Syndrome, Sleep Disorder

Keywords

Night Eating Syndrome, Nutrition, Metabolic Syndrome

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.

Interventions

OTHERDietary

The diet of these healthy volunteers was such that no calories were consumed after 19.30 in the evening in the first week, and in the second week, 25% of the daily calorie need calculated according to the Harris - Benedict formula was taken, taking into account the nighttime eating syndrome (NES) criteria, after 20.30 in the evening.

Sponsors

Koc University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Nutritional study with a single-arm cross-over design

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the concentration albuminuria in the Nighttime Eating Period1 weekMore than 20% increase during night feeding period
Change of the concentration of serum melatonin levels in the Nighttime Eating Period1 weekMore than 50% increase during night feeding period
Change of the concentration of serum leptin levels in the Nighttime Eating Period1 weekMore than 50% increase during night feeding period
Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period1 weekMore 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 Period1 weekMore than 20% increase during night feeding period
Change of Concentration of serum glucose in the Nighttime Eating Period1 weekMore than 10% increase during night feeding period
Change of Concentration of serum insulin in the Nighttime Eating Period1 weekMore than 10% increase during night feeding period
Change of concentration of serum Cortisol Level in the Nighttime Eating Period1 weekMore than 50% increase during night feeding period
Change of concentration of serum Fibroblast Growth Factor 21 Level in the Nighttime Eating Period1 weekMore than 10% increase during night feeding period
Change of the concentration of serum Cytokeratin 18 level in the Nighttime Eating Period1 weekMore than 10% increase during night feeding period
Change of value of Apnea Hypopnea Index in the Nighttime Eating Period1 weekThe 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026