Gastric EmptyingNCT07415616
Cold vs Warm Enteral Feeding and Gastric Emptying in Adult ICU Patients
A study testing enteral nutrition in people with Gastric Emptying and Enteral Nutrition (Food for Special Medical Purposes), run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Emptying, Enteral Nutrition (Food for Special Medical Purposes)
- What is being tested?
- enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Research and Education Hospital
Bursa
About this study
Official title: 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.
- Being tested
- enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionDietary supplement
Cold enteral feeding (24-25 degree), warm enteral feeding (36-37 degree)
enteral nutritionDietary supplement
cold enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Cold Enteral Feeding | Active comparator | Not described Receives: Dietary Supplement: enteral nutrition |
| Warm Enteral feeding | Active comparator | Not described Receives: Dietary Supplement: enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume measured by ultrasonography at 60, 90, 120, 180, 240, 360, and 480 minutes after administration of cold and warm enteral feeding.
Measured: Baseline (0 minutes) and up to 480 minutes after enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Sep 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilkay Ceylan, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415616
- Sponsor's protocol ID
- 2024-TBEK 2025/08-17
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of the limited sample size, potential risks to participant confidentiality, and institutional restrictions on data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cold and Warm Enteral Feeding on Gastric Emptying in Adult Intensive Care Patients: A Cross-Over Study
- ClinicalTrials.gov ID
- NCT07415616
- Acronym / sponsor ID
- 2024-TBEK 2025/08-17
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Feb 2026 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Enteral Feeding | Active comparator | Dietary Supplement: enteral nutrition |
| Warm Enteral feeding | Active comparator | Dietary Supplement: enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| enteral nutritionCold enteral feeding (24-25 degree), warm enteral feeding (36-37 degree) | Dietary supplement | Cold Enteral Feeding |
| enteral nutritioncold enteral nutrition | Dietary supplement | Warm Enteral feeding |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of the limited sample size, potential risks to participant confidentiality, and institutional restrictions on data sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition in people with Gastric Emptying and Enteral Nutrition (Food for Special Medical Purposes), run by Bursa Yuksek Ihtisas Training and Research 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 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: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 18 Feb 2026.