Night Eating SyndromeNCT06588088
Cardiorenal and Metabolic Effects of Nighttime Eating
A study testing Dietary in people with Night Eating Syndrome and Metabolic Syndrome, run by Koc University Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Night Eating Syndrome, Metabolic Syndrome, Cardiorenal Syndrome
- What is being tested?
- Dietary
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -<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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiorenal, Metabolic and Circadian 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.
Read the 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.
- Being tested
- Dietary
- Keywords
- Night Eating Syndrome, Nutrition, Metabolic Syndrome
- Medical subject headings
- Night Eating Syndrome, Metabolic Syndrome, Cardio-Renal Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dietary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the concentration albuminuria in the Nighttime Eating Period
More than 20% increase during night feeding period
Measured: 1 week
Change of the concentration of serum melatonin levels in the Nighttime Eating Period
More than 50% increase during night feeding period
Measured: 1 week
Change of the concentration of serum leptin levels in the Nighttime Eating Period
More than 50% increase during night feeding period
Measured: 1 week
Change of the Concentration of serum ghrelin Levels in the Nighttime Eating Period
More than 50% increase during night feeding period
Measured: 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
Measured: 1 week
Change of Concentration of serum glucose in the Nighttime Eating Period
More than 10% increase during night feeding period
Measured: 1 week
Change of Concentration of serum insulin in the Nighttime Eating Period
More than 10% increase during night feeding period
Measured: 1 week
Change of concentration of serum Cortisol Level in the Nighttime Eating Period
More than 50% increase during night feeding period
Measured: 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
Measured: 1 week
Change of the concentration of serum Cytokeratin 18 level in the Nighttime Eating Period
More than 10% increase during night feeding period
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Night Eating SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Nutritional study with a single-arm cross-over design
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Erkam Kesgin, Koc University Hospital
- Investigators
- Mehmet Kanbay, Medical Doctor, Study director, Koc University, School Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588088
- Sponsor's protocol ID
- 2022.093.IRB1.039
- Status last verified
- Aug 2025
- First submitted
- 16 Feb 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorenal, Metabolic and Circadian Effects of Nighttime Eating
- ClinicalTrials.gov ID
- NCT06588088
- Acronym / sponsor ID
- 2022.093.IRB1.039
- Keywords
- Night Eating Syndrome, Nutrition, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nutritional study with a single-arm cross-over design
| Arm | Type | Receives |
|---|---|---|
| Early eaters | Placebo comparator | Other: DietaryThe 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 | Active comparator | Other: DietaryThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- -<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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietaryThe 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. | Other | Early eaters, Night time Eaters |
Primary outcome
Change of the concentration albuminuria in the Nighttime Eating Period
Time frame: 1 week
More than 20% increase during night feeding period
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
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
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
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
Change of Concentration of serum glucose in the Nighttime Eating Period
Time frame: 1 week
More than 10% increase during night feeding period
Change of Concentration of serum insulin in the Nighttime Eating Period
Time frame: 1 week
More than 10% increase during night feeding period
Change of concentration of serum Cortisol Level in the Nighttime Eating Period
Time frame: 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
Time frame: 1 week
More than 10% increase during night feeding period
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Kanbay, Medical Doctor study director
Koc University, School Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary in people with Night Eating Syndrome and Metabolic Syndrome, run by Koc University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the concentration albuminuria in the Nighttime Eating Period (time frame: 1 week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.