Skip to content

Evaluating nutrient regulation in ICU survivors: A prospective cohort study

Nutrient regulation in ICU survivors: Investigating psychological factors associated with nutrient intake in a prospective cohort

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000845932
Enrollment
45
Registered
2020-08-27
Start date
2020-11-06
Completion date
2021-12-16
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 assesse

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.

Sponsors

Royal Adelaide Hospital.
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026