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

Primary Purpose

Ketosis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketogenic Feed
Standard Feed
Sponsored by
University Hospitals Bristol and Weston NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketosis focused on measuring Ketone Bodies, Enteral Nutrition, Ketogenic Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ketogenic Feed

    Standard Feed

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 26, 2016
    Last Updated
    November 8, 2016
    Sponsor
    University Hospitals Bristol and Weston NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02763553
    Brief Title
    Does a Ketogenic Diet Causes Ketosis in Patients on Intensive Care?
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospitals Bristol and Weston NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ketosis
    Keywords
    Ketone Bodies, Enteral Nutrition, Ketogenic Diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketogenic Feed
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard Feed
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ketogenic Feed
    Other Intervention Name(s)
    Nutrison KetoCal 4:1
    Intervention Description
    A low-carbohydrate, high-fat feed designed to induce a ketotic state.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Standard Feed
    Other Intervention Name(s)
    Nutrison ProteinPlus MultiFibre 1.28
    Intervention Description
    Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
    Primary Outcome Measure Information:
    Title
    Median serum ketone level
    Description
    Serum ketone levels (mmol/L) will be recorded 4-hourly in each group. The median serum ketone level (mmol/L) will be calculated.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Time to achieve serum ketosis
    Description
    Time taken (hours) to achieve a clinically relevant ketosis (serum ketone > 0.3mmol/L) from introduction of an enteral ketogenic feed.
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kieron D Rooney, MBBS
    Phone
    +44 117 342 7137
    Email
    Kieron.Rooney@UHBristol.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kieron D Rooney, MBBS
    Organizational Affiliation
    University Hospitals Bristol and Weston NHS Foundation Trust
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    No, anonymised data only

    Learn more about this trial

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