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Completed

NCT Number: NCT06588088

Cardiorenal and Metabolic Effects of Nighttime Eating

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.

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Key information

Conditions

Night Eating Syndrome Cardio-Renal Syndrome Cardiorenal Syndrome Cardiovascular Diseases Feeding and Eating Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperinsulinism Insulin Resistance Kidney Diseases Male Urogenital Diseases Mental Disorders Metabolic Diseases Metabolic Syndrome Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Sleep Disorder Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary

Other

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.

Primary outcomes

  1. Change of the concentration albuminuria in the Nighttime Eating Period

    Time frame: 1 week

    More than 20% increase during night feeding period

  2. Change of the concentration of serum melatonin levels in the Nighttime Eating Period

    Time frame: 1 week

    More than 50% increase during night feeding period

  3. Change of the concentration of serum leptin levels in the Nighttime Eating Period

    Time frame: 1 week

    More than 50% increase during night feeding period

  4. Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period

    Time frame: 1 week

    More than 50% increase during night feeding period

  5. Change of the concentration of serum total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride levels in the Nighttime Eating Period

    Time frame: 1 week

    More than 20% increase during night feeding period

  6. Change of Concentration of serum glucose in the Nighttime Eating Period

    Time frame: 1 week

    More than 10% increase during night feeding period

  7. Change of Concentration of serum insulin in the Nighttime Eating Period

    Time frame: 1 week

    More than 10% increase during night feeding period

  8. Change of concentration of serum Cortisol Level in the Nighttime Eating Period

    Time frame: 1 week

    More than 50% increase during night feeding period

  9. Change of concentration of serum Fibroblast Growth Factor 21 Level in the Nighttime Eating Period

    Time frame: 1 week

    More than 10% increase during night feeding period

  10. Change of the concentration of serum Cytokeratin 18 level in the Nighttime Eating Period

    Time frame: 1 week

    More than 10% increase during night feeding period

  11. Change of value of Apnea Hypopnea Index in the Nighttime Eating Period

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Koc University Hospital

Other

Registry information

Official study title

Cardiorenal, Metabolic and Circadian Effects of Nighttime Eating

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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