- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415616
Cold vs Warm Enteral Feeding and Gastric Emptying in Adult ICU Patients
February 16, 2026 updated by: Ilkay Ceylan, Bursa Yuksek Ihtisas Training and Research Hospital
Effect of Cold and Warm Enteral Feeding on Gastric Emptying in Adult Intensive Care Patients: A Cross-Over Study
In critically ill patients receiving enteral nutrition in the intensive care unit, the functional capacity of the gastrointestinal system can be significantly influenced by the mode of nutritional support.
The temperature of enteral feeding may exert potential effects on gastric emptying, intestinal motility, and nutrient absorption.
However, the existing literature on the impact of feeding temperature is limited, and randomized or cross-over controlled studies directly comparing warm and cold enteral feeding are scarce.
This study aims to systematically evaluate the effects of enteral feeding temperature on feeding tolerance (vomiting and aspiration), gastric emptying rate (gastric residual volume), and the incidence of diarrhea, thereby providing evidence to inform clinical practice.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bursa, Turkey (Türkiye)
- Bursa Yuksek Ihtisas Research and Education Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 18 years or older
- Expected length of stay in the intensive care unit of at least 96 hours
- Patients receiving enteral nutrition via a nasogastric tube
- Absence of ileus or active gastrointestinal bleeding
Exclusion Criteria:
- Patients younger than 18 years of age
- Use of high-dose opioids known to affect gastrointestinal motility
- Patients receiving parenteral nutrition
- Known gastrointestinal diseases or a history of gastrointestinal surgery
- Patients with acute intracranial events will not be included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cold Enteral Feeding
|
Cold enteral feeding (24-25 degree), warm enteral feeding (36-37 degree)
cold enteral nutrition
|
|
Active Comparator: Warm Enteral feeding
|
Cold enteral feeding (24-25 degree), warm enteral feeding (36-37 degree)
cold enteral nutrition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gastric volume measured by ultrasonography at 60, 90, 120, 180, 240, 360, and 480 minutes after administration of cold and warm enteral feeding.
Time Frame: Baseline (0 minutes) and up to 480 minutes after enteral feeding
|
Baseline (0 minutes) and up to 480 minutes after enteral feeding
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
February 10, 2026
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 16, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-TBEK 2025/08-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared because of the limited sample size, potential risks to participant confidentiality, and institutional restrictions on data sharing.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Emptying
-
Mayo ClinicCompletedGastric EmptyingUnited States
-
Air Force Military Medical University, ChinaCompleted
-
Coombe Women and Infants University HospitalCompleted
-
Kangbuk Samsung HospitalUnknown
-
Maastricht University Medical CenterUnilever R&DCompleted
-
Guy's and St Thomas' NHS Foundation TrustCompleted
-
University Children's Hospital, ZurichCompleted
-
Federal University of Minas GeraisNestle Health ScienceRecruiting
-
Columbia UniversityRecruiting
-
Medical University of ViennaCompleted
Clinical Trials on enteral nutrition
-
University of Alabama at BirminghamActive, not recruitingEnteral Feeding Intolerance | Premature; Infant, Light-for-datesUnited States
-
Second Affiliated Hospital, School of Medicine,...Unknown
-
Nanjing University School of MedicineJinling Hospital, ChinaCompletedAcute Pancreatitis | Intra-abdominal HypertensionChina
-
Hacettepe UniversityAnkara Training and Research HospitalCompletedDiabetes Mellitus | Glycaemia | Glycemic Control for Diabetes MellitusTurkey
-
Ruijin HospitalRenJi HospitalUnknown
-
Centre Hospitalier Departemental VendeeInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsCompletedShock | Acute Respiratory FailureFrance
-
Shaikh Zayed Hospital, LahoreRecruitingUncomplicated Acute Appendicitis in ChildrenPakistan
-
Shanghai Zhongshan HospitalRenJi Hospital; Shanghai 10th People's Hospital; Shanghai Tong Ren Hospital; Xinhua... and other collaboratorsSuspended
-
Société des Produits Nestlé (SPN)Completed
-
Centre Hospitalier Departemental VendeeInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsTerminatedShock | Acute Respiratory FailureFrance