Cardiorenal and Metabolic Effects of Nighttime Eating

NCT06588088 | Completed

• 1 other identifier: 2022.093.IRB1.039
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Night Eating Syndrome; Metabolic Syndrome; Cardiorenal Syndrome; Sleep Disorder

Keywords

Night Eating Syndrome; Nutrition; Metabolic Syndrome

Outcome Measures

Primary Outcomes (11)

• Change of the concentration albuminuria in the Nighttime Eating Period

  More than 20% increase during night feeding period

  1 week

• Change of the concentration of serum melatonin levels in the Nighttime Eating Period

  More than 50% increase during night feeding period

  1 week

• Change of the concentration of serum leptin levels in the Nighttime Eating Period

  More than 50% increase during night feeding period

  1 week

• Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period

  More than 50% increase during night feeding period

  1 week

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

  More than 20% increase during night feeding period

  1 week

• Change of Concentration of serum glucose in the Nighttime Eating Period

  More than 10% increase during night feeding period

  1 week

• Change of Concentration of serum insulin in the Nighttime Eating Period

  More than 10% increase during night feeding period

  1 week

• Change of concentration of serum Cortisol Level in the Nighttime Eating Period

  More than 50% increase during night feeding period

  1 week

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

  More than 10% increase during night feeding period

  1 week

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

  More than 10% increase during night feeding period

  1 week

• Change of value of Apnea Hypopnea Index in the Nighttime Eating Period

  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

  1 week

Study Arms (2)

Early eaters

PLACEBO COMPARATOR

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.

Other: Dietary

Night time Eaters

ACTIVE COMPARATOR

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.

Other: Dietary

Interventions

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.

Early eaters; Night time Eaters

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Koc University Hospital: lead

Study Sites (1)

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Night Eating Syndrome; Metabolic Syndrome; Cardio-Renal Syndrome; Sleep Wake Disorders

Interventions

Diet

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mehmet Kanbay, Medical Doctor

  Koc University, School Of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Resident in Internal Medicine

Model Details: Nutritional study with a single-arm cross-over design

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)