Cardiorenal and Metabolic Effects of Nighttime Eating

NCT ID: NCT06588088

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Early eaters

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.

Group Type: PLACEBO_COMPARATOR

Dietary

Intervention Type: 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.

Night time Eaters

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.

Group Type: ACTIVE_COMPARATOR

Dietary

Intervention Type: 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.

Interventions

Dietary

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Koc University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yavuz Erkam Kesgin

Medical Doctor, Resident in Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Kanbay, Medical Doctor

Role: STUDY_DIRECTOR

Koc University, School Of Medicine

Locations

Koc University Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022.093.IRB1.039

Identifier Type: -

Identifier Source: org_study_id