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Trial registered on ANZCTR


Registration number
ACTRN12620000845932
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
27/08/2020
Date last updated
10/01/2023
Date data sharing statement initially provided
27/08/2020
Date results information initially provided
4/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating nutrient regulation in ICU survivors: A prospective cohort study
Scientific title
Nutrient regulation in ICU survivors: Investigating psychological factors associated with nutrient intake in a prospective cohort
Secondary ID [1] 301432 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Intensive Care Nutrition 317723 0
Critical illness 317726 0
Condition category
Condition code
Diet and Nutrition 315797 315797 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will observe the energy intake from a weighed, soft diet, energy buffet in adult survivors of critical illness, when compared to general hospitalised patients and healthy controls.

Following an overnight fast, participants will have their energy expenditure measured via indirect calorimetry using a metabolic cart (Quark CPET, Cosmed) over a 30-minute period, via a canopy hood. Objective measures of taste thresholds will be assessed using edible taste strips. Appetite will be assessed using a set of Visual Analogue Scales (VAS) at three timepoints (-30min (fasting), 180 mins (prior to buffet), 210 mins (post buffet)). Each VAS will consist of a 100 mm horizontal line, where 0 mm represents ‘sensation not felt at all’ and 100 mm ‘sensation felt the greatest’. The participant will be required to place a vertical mark along the line to indicate the strength of each sensation. Participants will be asked to consume 200 ml of a liquid test meal (Ensure Original (Abbott, 237 ml, 920 kJ, 9 g protein, 33 g carbohydrate, 6 g fat)) over a 5-minute interval, t= 0 mins when the liquid test meal has been consumed. Blood samples will be taken from a venous catheter every 15 minutes for the first hour and every 30 minutes thereafter for the study period. The resulting plasma/serum will be stored at -70º C for subsequent analysis. Hormones associated with appetite control will be analysed at each time-point over the study period, including ghrelin, leptin, insulin, peptide YY (PYY) and cholecystokinin (CCK). Antral area will be assessed using ultrasonography every 15 minutes for the first hour and at 30 minute intervals thereafter until 180 mins. At t=180 minutes, participants will be provided with a standard energy buffet (2666kcal, 123g protein, 81g fat, and 342g carbohydrate) modified to allow for soft diet, which has been validated to assess nutrient intake. Participants will be instructed to consume this buffet until they are comfortably full, within a 30 minute period. The amount of calories and macronutrients consumed will be quantified using Foodworks dietary analysis software (Xyris, Brisbane, Australia). The time taken to reach the point of satisfaction with this meal will also be recorded. The total duration for completion of all study specific procedures will be approximately 5 hours.

During the study day, a 24-hour recall of intake from the previous day will be conducted by a trained dietitian. Additionally, a Gastrointestinal Symptoms Questionnaire and a Patient-Generated Subjective Global Assessment (PG-SGA) will be used to assess the presence of gastrointestinal symptoms relating to barriers effecting nutritional intake, for example nausea, loss of appetite, bloating, problems swallowing, requirement for feeding assistance and dry mouth . Quality of life questionnaires will also be used: EQ-5D-5L and SF-36.
Intervention code [1] 317744 0
Diagnosis / Prognosis
Comparator / control treatment
The study will require two comparator groups, who will follow the same study procedures as the critically ill patient group.
• Group 2: General hospitalised patients:
Patients admitted to a RAH General Medical Unit will be screened for eligibility on admission and recruited prospectively if able to complete measures within 7 days of admission.
• Group 3: Healthy participants:
Healthy subjects will be recruited from an existing pool of healthy volunteers or by flyers placed around the major Hospitals in Adelaide, the University of Adelaide and the University of South Australia, or, if required, by classified advertisements placed in local newspapers or online noticeboards.
Control group
Active

Outcomes
Primary outcome [1] 324009 0
Energy intake from weighed energy buffet meal.
Timepoint [1] 324009 0
180 mins post test-meal consumption.
Secondary outcome [1] 383540 0
Cross-sectional antral area as a measure of satiety, measured by ultrasonography.
Timepoint [1] 383540 0
Antral area will be assessed using ultrasonography immediately before the test drink,
immediately following the test drink (t=0 mins), every 15 minutes for the first hour and at 30 minute intervals thereafter until the buffet meal is provided (t=180 mins).
Secondary outcome [2] 383541 0
Self-perceived appetite as per visual analogue scale.
Timepoint [2] 383541 0
At three timepoints during the study:
1. Fasted state (t=-10 mins)
2. Delayed post-prandial phase (t=180 mins)
3. Immediate post-prandial phase (t=210 mins).
Secondary outcome [3] 383542 0
Gastrointestinal symptoms self reported in a questionnaire (PG-SGA).
Timepoint [3] 383542 0
Assessed once during the study day.
Secondary outcome [4] 383545 0
Taste thresholds assessed by edible taste strips placed on the tongue.
Timepoint [4] 383545 0
Assessed once at the start of the study day, prior to the test liquid meal, when the patient is fasted.
Secondary outcome [5] 383546 0
Quality of life will be assessed using the EQ-5D-5L and SF-36 questionnaires.
Timepoint [5] 383546 0
Assessed once during the study day.
Secondary outcome [6] 384383 0
Area under the concentration time curves of grehlin concentration, from venous blood samples.
Timepoint [6] 384383 0
Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
Secondary outcome [7] 384384 0
Area under the concentration time curves of leptin concentration, from venous blood samples.
Timepoint [7] 384384 0
Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
Secondary outcome [8] 384385 0
Area under the concentration time curves of insulin concentration, from venous blood samples.
Timepoint [8] 384385 0
Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
Secondary outcome [9] 384386 0
Area under the concentration time curves of peptide YY (PYY) concentration, from venous blood samples.
Timepoint [9] 384386 0
Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
Secondary outcome [10] 384387 0
Area under the concentration time curves of cholecystokinin (CCK) concentration, from venous blood samples.
Timepoint [10] 384387 0
Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
Secondary outcome [11] 384388 0
Area under the concentration time curves of glucose concentration, from venous blood samples.
Timepoint [11] 384388 0
Every 15 minutes for the first hour and every 30 minutes thereafter for the study period, prior to administering the buffet meal (-10, 15, 30, 45, 60, 90, 120, 150, 180 mins).
Secondary outcome [12] 385131 0
24-hour recall of diary intake
Timepoint [12] 385131 0
Dietary intake from day prior to study

Eligibility
Key inclusion criteria
Group 1: Critically ill patients:
Patients admitted to the Royal Adelaide Hospital ICU will be screened for eligibility on admission and recruited prospectively on ICU discharge if able to complete measures within 7 days of ICU discharge.

Inclusions:
• Adults (18 years and above)
• Were admitted to the RAH ICU during this hospital admission
• ICU length of stay >72 hours

Group 2: General hospitalised patients:
Patients admitted to a RAH General Medical Unit will be screened for eligibility on admission and recruited prospectively if able to complete measures within 7 days of admission.

Inclusions:
• Adults (18 years and above)
• Admitted to the RAH general medicine ward

Group 3: Healthy participants:
25 age-, sex-, and BMI-matched healthy participants will be recruited from an existing pool of healthy volunteers or by flyers.

Inclusion:
• Adults (18 years and above)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for Group 1 and 2:
• Patients unable to follow commands and give informed consent (i.e. head injured, subarachnoid haemorrhage and history of dementia)
• Unable to consume energy buffet e.g. remains on enteral or parenteral nutrition, thickened fluids/texture modified diet, vegan/vegetarian, lactose/gluten intolerant
• Major gastrointestinal surgery on this admission or previous admissions
• Pregnancy

Additional exclusion criteria have been included to ensure the healthy participant cohort recruited is representative of a healthy population.
Exclusion for group 3:
• Inability to give informed consent
• Significant illness
• Smokers (cigarettes/cigars/marijuana)
• Intake of >2 standard drinks on >5 days per week
• Intake of >4 cups of caffeinated drinks per day
• Intake of any illicit substance
• Unable to consume energy buffet e.g. thickened fluids/texture modified diet, vegan/vegetarian, lactose/gluten intolerant
• Significant gastrointestinal symptoms, disease or surgery (apart from uncomplicated appendectomy)
• Pregnancy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary outcome will be the difference in energy intake from weighed energy buffet between the critically ill patient group and the two comparator groups (General hospitalised patients and Healthy participants). Based on our previous study in ICU survivors, the standard deviation in calorie intake from the weighed buffet meal was 346 kcal. A sample size of 25 ICU patients and 25 ward patients will provide 80% power at the 0.05 significance level, to detect a difference in calorie intake of 280 kcal. This was chosen a priori to be of clinical relevance and likely to lead to a meaningful effect on nutritional status.

Differences in energy intake from weighed energy buffet, gastrointestinal hormone responses and antral area will be measured using Independent samples t-tests. VAS outcomes will be analysed using repeated measures analysis of variance (RM ANOVA) with effects for group, time (baseline, delayed post-prandial, immediate post-prandial), and the group by time interaction. Significant interactions will be followed by pairwise post-hoc tests comparing between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2020
Actual
6/11/2020
Date of last participant enrolment
Anticipated
Actual
16/12/2021
Date of last data collection
Anticipated
30/09/2022
Actual
16/12/2021
Sample size
Target
75
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16833 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 30474 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305871 0
Hospital
Name [1] 305871 0
Royal Adelaide Hospital Research Committee (RRC)
Country [1] 305871 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital.
Address
Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 306321 0
None
Name [1] 306321 0
Address [1] 306321 0
Country [1] 306321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306131 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 306131 0
Level 3, Roma Mitchell House
136 North Terrace, Adelaide SA 5000
Ethics committee country [1] 306131 0
Australia
Date submitted for ethics approval [1] 306131 0
Approval date [1] 306131 0
24/02/2020
Ethics approval number [1] 306131 0

Summary
Brief summary
This exploratory single-centre study will be conducted at the Royal Adelaide Hospital, South Australia. Patients will be recruited from two locations; the intensive care and general medical units. Healthy volunteers will be recruited from existing pools or through advertisements as required.
This study will recruit:
1. 25 ICU patients
2. 25 general medical patients
3. 25 healthy volunteers
The primary aim of this study is to determine whether energy intake as measured from a weighed, soft diet, energy buffet is reduced in adult survivors of critical illness when compared to general hospitalised patients and healthy controls.
This study will also aim to determine if there are impairments in the following mechanisms or psychological factors that regulate nutrient intake in survivors of critical illness when compared to general hospitalised patients and healthy controls:
a. Fasting and post-prandial gastrointestinal hormone response
b. Antral area
c. Self-perceived appetite
d. Gastrointestinal symptoms
e. Taste threshold
f. Quality of life
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102814 0
Dr Lee-anne Chapple
Address 102814 0
Intensive Care Research
Royal Adelaide Hospital
Port Road, Adelaide 5000, South Australia
Country 102814 0
Australia
Phone 102814 0
+61 8 7074 1763
Fax 102814 0
Email 102814 0
lee-anne.chapple@adelaide.edu.au
Contact person for public queries
Name 102815 0
Dr Lee-anne Chapple
Address 102815 0
Intensive Care Research
Royal Adelaide Hospital
Port Road, Adelaide 5000, South Australia
Country 102815 0
Australia
Phone 102815 0
+61 8 7074 1763
Fax 102815 0
Email 102815 0
lee-anne.chapple@adelaide.edu.au
Contact person for scientific queries
Name 102816 0
Dr Lee-anne Chapple
Address 102816 0
Intensive Care Research
Royal Adelaide Hospital
Port Road, Adelaide 5000, South Australia
Country 102816 0
Australia
Phone 102816 0
+61 8 7074 1763
Fax 102816 0
Email 102816 0
lee-anne.chapple@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be available, due to patient confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.