Critical IllnessNCT07063303
Circadian Rhythm in Critical Illness
A study testing Intermittent feeding and Continuous feeding in people with Critical Illness, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to determine whether intermittent enteral feeding positively influences circadian rhythms in critically ill patients in intensive care units (ICUs). The main research questions are: 1. Does intermittent feeding improve circadian rhythms in ICU patients? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Intermittent feeding and Continuous feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 29 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU admission for enteral feeding via a gastric tube
- Expected ≥10 days of enteral nutrition
- Age ≥18 years
Who cannot join
- Age <18 years
- Pregnancy
- Gastrointestinal surgery or diseases
- Tolerance issues with enteral feeding
- Parenteral feeding requirement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Feeding on Circadian Rhythm in Critical Illness
The goal of this clinical trial is to determine whether intermittent enteral feeding positively influences circadian rhythms in critically ill patients in intensive care units (ICUs). The main research questions are:
- Does intermittent feeding improve circadian rhythms in ICU patients?
- How does intermittent feeding affect metabolic markers and recovery outcomes? Researchers will compare intermittent feeding to continuous feeding, the current standard method, to assess its impact on circadian stability and patient health.
Read more
Participants will:
- Receive intermittent enteral feeding or continuous enteral feeding for at least 10 days
- Undergo blood sample collection at three time points daily (morning, afternoon, midnight) to analyze circadian gene expression and metabolic markers
- Have their clinical condition, nutrition status, and recovery progress monitored throughout the study
Read the detailed description
Circadian rhythms regulate various physiological processes over a 24-hour cycle, including sleep-wake patterns, digestion, blood pressure, and hormone secretion. These rhythms are primarily controlled by the suprachiasmatic nucleus in the hypothalamus and influenced by environmental cues (zeitgebers), such as light exposure and meal timing. Critically ill patients often experience circadian rhythm disruptions due to prolonged artificial lighting, sleep disturbances, and continuous feeding, which may negatively impact metabolic health, immune function, and recovery. Given the significance of meal timing in circadian regulation, intermittent feeding might serve as a therapeutic strategy to restore circadian balance in ICU patients.
This study is a prospective, randomized controlled trial and will be conducted at Ankara Training and Research Hospital's Anesthesia Intensive Care Unit. Ethical approval for the study has been obtained from Ankara Training and Research Hospital with decision number E-93471371-514.99-226714167.
Patients will be randomly assigned to one of two groups:
- Intermittent Feeding Group - enteral nutrition will be provided at scheduled intervals (4-6 times daily) for 20-60 minutes per session, aligning with circadian cycles. Light exposure will also be adjusted, ensuring darkness during night hours.
- Continuous Feeding Group - patients will receive standard continuous enteral nutrition, without specific adjustments for circadian rhythms.
Blood samples will be collected on Day 1 and Day 7 at 08:00, 16:00, and 00:00 to analyze Brain and muscle aryl hydrocarbon receptor nuclear antigen-1 (BMAL1), Cyrptochrome 1 (CRY1), and Period 2 (PER2) gene expression and biochemical markers. No invasive procedures will be performed beyond routine ICU care. Patients' medical history, nutritional status, and clinical parameters will be recorded by using Acute Physiology and Chronic Health Evaluation II (APACHE II) Score, Sequential Organ Failure Assessment (SOFA) Score, Nutrition Risk in Critically ill (NUTRIC) Score and Global Leadership Initiative on Malnutrition (GLIM) Criteria.
- Conditions
- Critical Illness
- Being tested
- Intermittent feeding, Continuous feeding
- Keywords
- critical illness, intermittent feeding, circadian rhythm
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent feedingOther
Feeding Frequency: Enteral nutrition will be provided every 4 to 6 hours via nasogastric tube.
Feeding Volume: Each session will deliver 240 to 720 mL of enteral formula. Feeding Duration: Each feeding session will last approximately 20 to 60 minutes.
Continuous feedingOther
Feeding Frequency: Enteral nutrition will be administered continuously for 20 hours per day via nasogastric tube.
Feeding Volume: The total daily volume will be divided evenly over the 20-hour infusion period, based on individual nutritional requirements.
Feeding Duration: Each 24-hour cycle includes 20 hours of continuous feeding followed by a 4-hour rest period.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Feeding Group | Active comparator | Patients receive enteral nutrition at scheduled intervals to align with circadian rhythms. Receives: Other: Intermittent feeding |
| Continuous Feeding Group | Active comparator | Patients receive enteral nutrition continuously, following the standard ICU practice. Receives: Other: Continuous feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMAL1 mRNA Expression Level
To evaluate the circadian rhythm in critically ill patients, BMAL1 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
Measured: From randomization to the end of intervention (7 days)
CRY1 mRNA Expression Level
To evaluate the circadian rhythm in critically ill patients, CRY1 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
Measured: From randomization to the end of intervention (7 days)
PER2 mRNA Expression Level
To evaluate the circadian rhythm in critically ill patients, PER2 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
Measured: From randomization to the end of intervention (7 days)
Secondary outcomes (20)
Fasting Glucose Level
This parameter will be analyzed from blood samples collected on the first and seventh days after randomization. Unit of Measure: mg/dL
Measured: From randomization to Day 7
C-reactive protein (CRP)
This parameter will be analyzed from blood samples collected on the first and seventh days after randomization. Unit of Measure: mg/L
Measured: From randomization to Day 7
Lactate Level
This parameter will be analyzed from blood samples collected on the first and seventh days after randomization. Unit of Measure: mmol/L
Measured: From randomization to Day 7
Creatinine Level
This parameter will be analyzed from blood samples collected on the first and seventh days after randomization. Unit of Measure: mg/dL
Measured: From randomization to Day 7
Bicarbonate Level
This parameter will be analyzed from blood samples collected on the first and seventh days after randomization. Unit of Measure: mmol/L
Measured: From randomization to Day 7
White Blood Cell (WBC) Count
WBC count (x10³/μL) will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Lymphocyte Count
Lymphocyte Count (x10³/μL) will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Neutrophil Count
Neutrophil Count (x10³/μL) will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Hemoglobin Level
Hemoglobin Level will be analyzed from blood samples collected on the first and seventh days after randomization. Unit of measure: g/dL
Measured: From randomization to Day 7
Platelet Count
Platelet Count (x10³/μL) will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Aspartate aminotransferase (AST) Levels
Aspartate aminotransferase (AST) (U/L) levels will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Alanine aminotransferase (ALT) Levels
Alanine aminotransferase (ALT) (U/L) levels will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Gamma glutamyl transferase (GGT) Levels
Gamma glutamyl transferase (GGT) (U/L) levels will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Blood Urea Nitrogen (BUN) Levels
Blood Urea Nitrogen (BUN) (mg/dL) levels will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Sodium Levels
Sodium (mmol/L) levels will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Potassium Levels
Potassium (mmol/L) levels will be analyzed from blood samples collected on the first and seventh days after randomization.
Measured: From randomization to Day 7
Acute Physiology and Chronic Health Evaluation II (APACHE-II) Score
The APACHE II score is a clinical tool used in intensive care units to assess the severity of a patient's illness and estimate the risk of hospital mortality. It is calculated based on physiological measurements, age, and chronic health conditions. Higher scores indicate more severe illness and a greater risk of death.
Unit of Measure: Score (0-71 scale) Interpretation: Higher scores correspond to increased severity and mortality risk.
Measured: First day of admission to the ICU
Sequential Organ Failure Assessment (SOFA) Score
The SOFA score evaluates the function of six organ systems-respiratory, cardiovascular, hepatic, coagulation, renal, and neurological-in critically ill patients. It is used to monitor the extent of organ dysfunction and predict clinical outcomes in the intensive care unit (ICU).
Unit of Measure: Score (0-24 scale) Interpretation: Higher scores indicate greater organ dysfunction and worse prognosis.
Measured: First day of admission to the ICU
Nutrition Risk in Critically ill (NUTRIC) Score
The NUTRIC score is a screening tool designed to identify critically ill patients at high nutritional risk. It incorporates factors such as age, severity of illness, comorbidities, and inflammation to guide nutritional interventions in the intensive care unit (ICU).
Unit of Measure: Score (0-10 scale) Interpretation: Higher scores indicate greater nutritional risk.
Measured: First day of admission to the ICU
Global Leadership Initiative on Malnutrition (GLIM) Criteria
The GLIM criteria provide a standardized framework to diagnose malnutrition based on a combination of phenotypic criteria (including weight loss, low BMI, and reduced muscle mass) and etiologic criteria (such as reduced food intake or disease burden/inflammation). These criteria are used across clinical settings to identify malnutrition and grade its severity.
Unit of Measure: Categorical (e.g., malnutrition diagnosed: yes/no; severity graded as mild, moderate, or severe)
Measured: First day of admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jul 2025
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients admitted to the ICU who require enteral feeding for at least 10 days are randomly assigned to one of two groups: Intermittent Feeding Group, where enteral product is administered in scheduled intervals aligned with circadian rhythms. Continuous Feeding Group, following the standard ICU practice of continuous enteral nutrition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aslı Akyol Mutlu, Prof., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063303
- Sponsor's protocol ID
- atılımnut
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) from this study due to ethical considerations and restrictions related to patient confidentiality in the ICU setting.
Publications
Sagun E, Akyol A, Kaymak C. Chrononutrition in Critical Illness. Nutr Rev. 2025 Mar 1;83(3):e1146-e1157. doi: 10.1093/nutrit/nuae078.
PubMed 38904422Theilla M, Rattanachaiwong S, Kagan I, Rigler M, Bendavid I, Singer P. Validation of GLIM malnutrition criteria for diagnosis of malnutrition in ICU patients: An observational study. Clin Nutr. 2021 May;40(5):3578-3584. doi: 10.1016/j.clnu.2020.12.021. Epub 2020 Dec 29.
PubMed 33413910Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, de Baptista GA, Barazzoni R, Blaauw R, Coats AJS, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren M, Siltharm S, Singer P, Tappenden KA, Velasco N, Waitzberg DL, Yamwong P, Yu J, Compher C, Van Gossum A. GLIM Criteria for the Diagnosis of Malnutrition: A Consensus Report From the Global Clinical Nutrition Community. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):32-40. doi: 10.1002/jpen.1440. Epub 2018 Sep 2.
PubMed 30175461Van Dyck L, Vanhorebeek I, Wilmer A, Schrijvers A, Derese I, Mebis L, Wouters PJ, Van den Berghe G, Gunst J, Casaer MP. Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study. Crit Care. 2020 May 24;24(1):249. doi: 10.1186/s13054-020-02987-3.
PubMed 32448392Kouw IWK, Heilbronn LK, van Zanten ARH. Intermittent feeding and circadian rhythm in critical illness. Curr Opin Crit Care. 2022 Aug 1;28(4):381-388. doi: 10.1097/MCC.0000000000000960. Epub 2022 Jul 5.
PubMed 35797531Sunderram J, Sofou S, Kamisoglu K, Karantza V, Androulakis IP. Time-restricted feeding and the realignment of biological rhythms: translational opportunities and challenges. J Transl Med. 2014 Mar 28;12:79. doi: 10.1186/1479-5876-12-79.
PubMed 24674294Ren CJ, Yao B, Tuo M, Lin H, Wan XY, Pang XF. Comparison of sequential feeding and continuous feeding on the blood glucose of critically ill patients: a non-inferiority randomized controlled trial. Chin Med J (Engl). 2021 Jul 20;134(14):1695-1700. doi: 10.1097/CM9.0000000000001684.
PubMed 34397596Dong J, Liu R, Li L, Yao L. [Effects of intermittent feeding and continuous feeding on muscle atrophy and nutritional status in critically ill patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Jul;33(7):844-848. doi: 10.3760/cma.j.cn121430-20210408-00517. Chinese.
PubMed 34412755Ichimaru S. Methods of Enteral Nutrition Administration in Critically Ill Patients: Continuous, Cyclic, Intermittent, and Bolus Feeding. Nutr Clin Pract. 2018 Dec;33(6):790-795. doi: 10.1002/ncp.10105. Epub 2018 Jun 20.
PubMed 29924423Jobanputra AM, Scharf MT, Androulakis IP, Sunderram J. Circadian Disruption in Critical Illness. Front Neurol. 2020 Aug 11;11:820. doi: 10.3389/fneur.2020.00820. eCollection 2020.
PubMed 32849248Acuna-Fernandez C, Marin JS, Diaz-Casado ME, Rusanova I, Darias-Delbey B, Perez-Guillama L, Florido-Ruiz J, Acuna-Castroviejo D. Daily Changes in the Expression of Clock Genes in Sepsis and Their Relation with Sepsis Outcome and Urinary Excretion of 6-Sulfatoximelatonin. Shock. 2020 May;53(5):550-559. doi: 10.1097/SHK.0000000000001433.
PubMed 31403491Diaz E, Diaz I, Del Busto C, Escudero D, Perez S. Clock Genes Disruption in the Intensive Care Unit. J Intensive Care Med. 2020 Dec;35(12):1497-1504. doi: 10.1177/0885066619876572. Epub 2019 Sep 11.
PubMed 31510864Maas MB, Iwanaszko M, Lizza BD, Reid KJ, Braun RI, Zee PC. Circadian Gene Expression Rhythms During Critical Illness. Crit Care Med. 2020 Dec;48(12):e1294-e1299. doi: 10.1097/CCM.0000000000004697.
PubMed 33031153Beyer SE, Salgado C, Garcao I, Celi LA, Vieira S. Circadian rhythm in critically ill patients: Insights from the eICU Database. Cardiovasc Digit Health J. 2021 Feb 17;2(2):118-125. doi: 10.1016/j.cvdhj.2021.01.004. eCollection 2021 Apr.
PubMed 35265899Coiffard B, Diallo AB, Culver A, Mezouar S, Hammad E, Vigne C, Nicolino-Brunet C, Dignat-George F, Baumstarck K, Boucekine M, Leone M, Mege JL. Circadian Rhythm Disruption and Sepsis in Severe Trauma Patients. Shock. 2019 Jul;52(1):29-36. doi: 10.1097/SHK.0000000000001241.
PubMed 30074979
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Feeding on Circadian Rhythm in Critical Illness
- ClinicalTrials.gov ID
- NCT07063303
- Acronym / sponsor ID
- atılımnut
- Conditions
- Critical Illness
- Keywords
- critical illness, intermittent feeding, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 14 Jul 2025 (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.
The goal of this clinical trial is to determine whether intermittent enteral feeding positively influences circadian rhythms in critically ill patients in intensive care units (ICUs). The main research questions are:
- Does intermittent feeding improve circadian rhythms in ICU patients?
- How does intermittent feeding affect metabolic markers and recovery outcomes? Researchers will compare intermittent feeding to continuous feeding, the current standard method, to assess its impact on circadian stability and patient health.
Participants will:
- Receive intermittent enteral feeding or continuous enteral feeding for at least 10 days
- Undergo blood sample collection at three time points daily (morning, afternoon, midnight) to analyze circadian gene expression and metabolic markers
- Have their clinical condition, nutrition status, and recovery progress monitored throughout the study
Detailed description
Circadian rhythms regulate various physiological processes over a 24-hour cycle, including sleep-wake patterns, digestion, blood pressure, and hormone secretion. These rhythms are primarily controlled by the suprachiasmatic nucleus in the hypothalamus and influenced by environmental cues (zeitgebers), such as light exposure and meal timing. Critically ill patients often experience circadian rhythm disruptions due to prolonged artificial lighting, sleep disturbances, and continuous feeding, which may negatively impact metabolic health, immune function, and recovery. Given the significance of meal timing in circadian regulation, intermittent feeding might serve as a therapeutic strategy to restore circadian balance in ICU patients.
This study is a prospective, randomized controlled trial and will be conducted at Ankara Training and Research Hospital's Anesthesia Intensive Care Unit. Ethical approval for the study has been obtained from Ankara Training and Research Hospital with decision number E-93471371-514.99-226714167.
Patients will be randomly assigned to one of two groups:
- Intermittent Feeding Group - enteral nutrition will be provided at scheduled intervals (4-6 times daily) for 20-60 minutes per session, aligning with circadian cycles. Light exposure will also be adjusted, ensuring darkness during night hours.
- Continuous Feeding Group - patients will receive standard continuous enteral nutrition, without specific adjustments for circadian rhythms.
Blood samples will be collected on Day 1 and Day 7 at 08:00, 16:00, and 00:00 to analyze Brain and muscle aryl hydrocarbon receptor nuclear antigen-1 (BMAL1), Cyrptochrome 1 (CRY1), and Period 2 (PER2) gene expression and biochemical markers. No invasive procedures will be performed beyond routine ICU care. Patients' medical history, nutritional status, and clinical parameters will be recorded by using Acute Physiology and Chronic Health Evaluation II (APACHE II) Score, Sequential Organ Failure Assessment (SOFA) Score, Nutrition Risk in Critically ill (NUTRIC) Score and Global Leadership Initiative on Malnutrition (GLIM) Criteria.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients admitted to the ICU who require enteral feeding for at least 10 days are randomly assigned to one of two groups: Intermittent Feeding Group, where enteral product is administered in scheduled intervals aligned with circadian rhythms. Continuous Feeding Group, following the standard ICU practice of continuous enteral nutrition.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Feeding Group | Active comparator | Other: Intermittent feedingPatients receive enteral nutrition at scheduled intervals to align with circadian rhythms. |
| Continuous Feeding Group | Active comparator | Other: Continuous feedingPatients receive enteral nutrition continuously, following the standard ICU practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU admission for enteral feeding via a gastric tube
- Expected ≥10 days of enteral nutrition
- Age ≥18 years
Key exclusion criteria (5 listed)
- Age <18 years
- Pregnancy
- Gastrointestinal surgery or diseases
- Tolerance issues with enteral feeding
- Parenteral feeding requirement
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 |
|---|---|---|
| Intermittent feedingFeeding Frequency: Enteral nutrition will be provided every 4 to 6 hours via nasogastric tube. Feeding Volume: Each session will deliver 240 to 720 mL of enteral formula. Feeding Duration: Each feeding session will last approximately 20 to 60 minutes. | Other | Intermittent Feeding Group |
| Continuous feedingFeeding Frequency: Enteral nutrition will be administered continuously for 20 hours per day via nasogastric tube. Feeding Volume: The total daily volume will be divided evenly over the 20-hour infusion period, based on individual nutritional requirements. Feeding Duration: Each 24-hour cycle includes 20 hours of continuous feeding followed by a 4-hour rest period. | Other | Continuous Feeding Group |
Primary outcome
BMAL1 mRNA Expression Level
Time frame: From randomization to the end of intervention (7 days)
To evaluate the circadian rhythm in critically ill patients, BMAL1 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
CRY1 mRNA Expression Level
Time frame: From randomization to the end of intervention (7 days)
To evaluate the circadian rhythm in critically ill patients, CRY1 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
PER2 mRNA Expression Level
Time frame: From randomization to the end of intervention (7 days)
To evaluate the circadian rhythm in critically ill patients, PER2 gene expression will be measured using blood samples collected at 08:00, 16:00, and 00:00 on Day 1 and Day 7
20 secondary outcomes
Fasting Glucose Level
Time frame: From randomization to Day 7
C-reactive protein (CRP)
Time frame: From randomization to Day 7
Lactate Level
Time frame: From randomization to Day 7
Creatinine Level
Time frame: From randomization to Day 7
Bicarbonate Level
Time frame: From randomization to Day 7
White Blood Cell (WBC) Count
Time frame: From randomization to Day 7
Lymphocyte Count
Time frame: From randomization to Day 7
Neutrophil Count
Time frame: From randomization to Day 7
Hemoglobin Level
Time frame: From randomization to Day 7
Platelet Count
Time frame: From randomization to Day 7
Aspartate aminotransferase (AST) Levels
Time frame: From randomization to Day 7
Alanine aminotransferase (ALT) Levels
Time frame: From randomization to Day 7
Gamma glutamyl transferase (GGT) Levels
Time frame: From randomization to Day 7
Blood Urea Nitrogen (BUN) Levels
Time frame: From randomization to Day 7
Sodium Levels
Time frame: From randomization to Day 7
Potassium Levels
Time frame: From randomization to Day 7
Acute Physiology and Chronic Health Evaluation II (APACHE-II) Score
Time frame: First day of admission to the ICU
Sequential Organ Failure Assessment (SOFA) Score
Time frame: First day of admission to the ICU
Nutrition Risk in Critically ill (NUTRIC) Score
Time frame: First day of admission to the ICU
Global Leadership Initiative on Malnutrition (GLIM) Criteria
Time frame: First day of admission to the ICU
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 3 Oct 2025.
- Background: PubMed 38904422Sagun E, Akyol A, Kaymak C. Chrononutrition in Critical Illness. Nutr Rev. 2025 Mar 1;83(3):e1146-e1157. doi: 10.1093/nutrit/nuae078.
- Background: PubMed 33413910Theilla M, Rattanachaiwong S, Kagan I, Rigler M, Bendavid I, Singer P. Validation of GLIM malnutrition criteria for diagnosis of malnutrition in ICU patients: An observational study. Clin Nutr. 2021 May;40(5):3578-3584. doi: 10.1016/j.clnu.2020.12.021. Epub 2020 Dec 29.
- Background: PubMed 30175461Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, de Baptista GA, Barazzoni R, Blaauw R, Coats AJS, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren M, Siltharm S, Singer P, Tappenden KA, Velasco N, Waitzberg DL, Yamwong P, Yu J, Compher C, Van Gossum A. GLIM Criteria for the Diagnosis of Malnutrition: A Consensus Report From the Global Clinical Nutrition Community. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):32-40. doi: 10.1002/jpen.1440. Epub 2018 Sep 2.
- Background: PubMed 32448392Van Dyck L, Vanhorebeek I, Wilmer A, Schrijvers A, Derese I, Mebis L, Wouters PJ, Van den Berghe G, Gunst J, Casaer MP. Towards a fasting-mimicking diet for critically ill patients: the pilot randomized crossover ICU-FM-1 study. Crit Care. 2020 May 24;24(1):249. doi: 10.1186/s13054-020-02987-3.
- Background: PubMed 35797531Kouw IWK, Heilbronn LK, van Zanten ARH. Intermittent feeding and circadian rhythm in critical illness. Curr Opin Crit Care. 2022 Aug 1;28(4):381-388. doi: 10.1097/MCC.0000000000000960. Epub 2022 Jul 5.
- Background: PubMed 24674294Sunderram J, Sofou S, Kamisoglu K, Karantza V, Androulakis IP. Time-restricted feeding and the realignment of biological rhythms: translational opportunities and challenges. J Transl Med. 2014 Mar 28;12:79. doi: 10.1186/1479-5876-12-79.
- Background: PubMed 34397596Ren CJ, Yao B, Tuo M, Lin H, Wan XY, Pang XF. Comparison of sequential feeding and continuous feeding on the blood glucose of critically ill patients: a non-inferiority randomized controlled trial. Chin Med J (Engl). 2021 Jul 20;134(14):1695-1700. doi: 10.1097/CM9.0000000000001684.
- Background: PubMed 34412755Dong J, Liu R, Li L, Yao L. [Effects of intermittent feeding and continuous feeding on muscle atrophy and nutritional status in critically ill patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Jul;33(7):844-848. doi: 10.3760/cma.j.cn121430-20210408-00517. Chinese.
- Background: PubMed 29924423Ichimaru S. Methods of Enteral Nutrition Administration in Critically Ill Patients: Continuous, Cyclic, Intermittent, and Bolus Feeding. Nutr Clin Pract. 2018 Dec;33(6):790-795. doi: 10.1002/ncp.10105. Epub 2018 Jun 20.
- Background: PubMed 32849248Jobanputra AM, Scharf MT, Androulakis IP, Sunderram J. Circadian Disruption in Critical Illness. Front Neurol. 2020 Aug 11;11:820. doi: 10.3389/fneur.2020.00820. eCollection 2020.
- Background: PubMed 31403491Acuna-Fernandez C, Marin JS, Diaz-Casado ME, Rusanova I, Darias-Delbey B, Perez-Guillama L, Florido-Ruiz J, Acuna-Castroviejo D. Daily Changes in the Expression of Clock Genes in Sepsis and Their Relation with Sepsis Outcome and Urinary Excretion of 6-Sulfatoximelatonin. Shock. 2020 May;53(5):550-559. doi: 10.1097/SHK.0000000000001433.
- Background: PubMed 31510864Diaz E, Diaz I, Del Busto C, Escudero D, Perez S. Clock Genes Disruption in the Intensive Care Unit. J Intensive Care Med. 2020 Dec;35(12):1497-1504. doi: 10.1177/0885066619876572. Epub 2019 Sep 11.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) from this study due to ethical considerations and restrictions related to patient confidentiality in the ICU setting.
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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.
Aslı Akyol Mutlu, Prof. study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent feeding and Continuous feeding in people with Critical Illness, run by Atılım University 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 3 inclusion and 5 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 3 Oct 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. 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?
BMAL1 mRNA Expression Level (time frame: From randomization to the end of intervention (7 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063303, which also lists 17 linked publications.
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 3 Oct 2025; AzTrials last refreshed its copy on 5 Nov 2026.