Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?

Study Overview
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Brief Summary
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The purpose of this study is to assess if an enteral ketogenic feed will cause a ketotic state in critically ill patients on intensive care.

Detailed Description
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This pilot study is a prospective, single-centre, unblinded, parallel-group, randomised controlled, Phase IIb trial comparing standard enteral nutrition with an enteral ketogenic feed. The trial has a simple, pragmatic design and will be analysed on an intention-to-treat basis. It aims to recruit 10 patients from a single University teaching hospital adult general ICU. The anticipated recruitment period is 4 weeks. 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.

Official Title
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Does a Ketogenic Diet Reduce Delirium in Intensive Care? Part 1: - A Feasibility Study to Test if a Ketogenic Diet Causes Ketosis in Patients on Intensive Care

Conditions
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Ketosis

Intervention / Treatment
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* Dietary Supplement: Ketogenic Feed
* Dietary Supplement: Standard Feed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who require mechanical ventilation within 72 hours of admission to intensive care Exclusion Criteria: Known intolerance to the ketogenic diet 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic Feed<br>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. | Dietary Supplement: Ketogenic Feed<br>* A low-carbohydrate, high-fat feed designed to induce a ketotic state.<br>* Other names: Nutrison KetoCal 4:1;|
| Active Comparator: Standard Feed<br>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. | Dietary Supplement: Standard Feed<br>* Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube<br>* Other names: Nutrison ProteinPlus MultiFibre 1.28;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median serum ketone level | Serum ketone levels (mmol/L) will be recorded 4-hourly in each group. The median serum ketone level (mmol/L) will be calculated. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve serum ketosis | Time taken (hours) to achieve a clinically relevant ketosis (serum ketone > 0.3mmol/L) from introduction of an enteral ketogenic feed. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketone Bodies, Enteral Nutrition, Ketogenic Diet