Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
NCT ID: NCT02763553
Last Updated: 2016-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2016-12-31
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Adult patients admitted to intensive care and expected to require enteral feed via a nasogastric tube for at least 5 days and who fulfil other eligibility criteria will be allocated at random to receive either standard feed (Nutrison Protein Plus Multi Fibre) or a ketogenic enteral feed (Nutrison KetoCal 4:1).
The primary endpoint will be increase in ketone body concentration in serum. Secondary endpoints will include, time taken to achieve a ketotic state, ketone levels in critical care patients who are not absorbing enteral feed, glucose levels in patients on a ketone feed, triglyceride and cholesterol levels, creatinine kinase levels and development of a metabolic acidosis.
Adult ICU patients will be eligible to be included in this study if they are expected to require enteral feed via a nasogastric or nasojejunal tube or established percutaneous jejunostomy for at least 5 days. Practically, this will be achieved by screening ventilated patients as they will require enteral feeding Major exclusion criteria include contraindications to ketogenic feeds, contraindications to enteral feeding, a new (\< 5 days) percutaneous jejunostomy.
The intervention will continue until 14 days if the patient still requires enteral nutrition or until able to commence a normal diet orally.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Feed
Standard enteral feed (Nutrison ProteinPlus MF 1.28) containing 11.1g of carbohydrate and 3.8g of fat per 100kcal. Given as a continuous feed via a naso-gastric tube as per standard feeding protocol.
Standard Feed
Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
Ketogenic Feed
A low-carbohydrate, high-fat enteral feed (Nutrison KetoCal 4:1) containing 0.4g of carbohydrate and 10g of fat per 100kcal. Given as a continuous feed via a naso-gastric tube as per standard feeding protocol.
Ketogenic Feed
A low-carbohydrate, high-fat feed designed to induce a ketotic state.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketogenic Feed
A low-carbohydrate, high-fat feed designed to induce a ketotic state.
Standard Feed
Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Contraindication to standard protocolised enteral feeding
* Pregnancy
* Severe liver disease (known decompensated liver cirrhosis, previous liver transplant, acute hepatitis (bilirubin \>100, ALT \>500)
* Severe metabolic acidosis (pH \< 7.2, HCO3 \< 15mmol/L) that has not been corrected prior to enrolment in the study
* Patients predicted to stay less than 24 hours on intensive care
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospitals Bristol and Weston NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kieron D Rooney, MBBS
Role: STUDY_CHAIR
University Hospitals Bristol and Weston NHS Foundation Trust
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AN/2015/5042
Identifier Type: -
Identifier Source: org_study_id