Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000626561
Ethics application status
Approved
Date submitted
1/05/2024
Date registered
14/05/2024
Date last updated
14/05/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening and prevalence of high nutrition risk, energy expenditure and nitrogen turnover in inflammatory bowel disease (IBD)
Scientific title
Screening and prevalence of high nutrition risk, energy expenditure and nitrogen turnover in inflammatory bowel disease (IBD)-Ulcerative colitis and metabolic monitoring
Secondary ID [1] 311820 0
nil known
Universal Trial Number (UTN)
Trial acronym
SPENT – IBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 333349 0
Condition category
Condition code
Oral and Gastrointestinal 330030 330030 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Days
Description of intervention(s) / exposure
Participants will be asked to complete a 72 hour weighed food diary. Participants will weigh all their food consumed and record this in the free app "easy diet diary" over a 72 hour period.

During the final 24 hours of the weighed food diary, participants will be asked to complete a 24-hour urine and stool collection. These will be stored in a portable refrigerator provided by the study team.

On the morning of day 4, Participants will then attend a single appointment with a researcher lasting approximately 1 hour to complete indirect calorimetry (2x 10 minute measures) and body composition assessment including SGA. Participants will return stool and urine samples at this time.
Intervention code [1] 328578 0
Early Detection / Screening
Comparator / control treatment
A subset of age and gender matched healthy controls will be included in the study.
Control group
Active

Outcomes
Primary outcome [1] 337783 0
Protein nitrogen balance presented in grams/kg/day
Timepoint [1] 337783 0
Cross sectional single time point.

Participants collect a 3 day weighed food diary and attend a single appointment the morning of day 4.
Primary outcome [2] 337784 0
Resting energy expenditure presented in Kcal/kg/day
Timepoint [2] 337784 0
Cross sectional analysis - Single timepoint
Timepoint will occur on the morning of day 4, following the 3 day weighed food diary.
Secondary outcome [1] 433321 0
Malnutrition will be measured using the validated subjective global assessment (SGA).
Timepoint [1] 433321 0
Cross sectional analysis - Single timepoint
This will be completed following indirect calorimetry on the morning of day 4.
Secondary outcome [2] 433322 0
Nutrition risk measured with the inflammatory bowel disease - nutrition screening tool (IBD-NST)
Timepoint [2] 433322 0
Cross sectional analysis - Single timepoint
This will be completed following indirect calorimetry on the morning of day 4.
Secondary outcome [3] 433324 0
Weight status presented in kilograms (Kgs) and converted into body mass index (BMI)
Timepoint [3] 433324 0
Cross sectional study - single time point
This will be completed following indirect calorimetry on the morning of day 4.

Eligibility
Key inclusion criteria
Established diagnosis of ulcerative colitis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age under 18 years
Pregnancy and breastfeeding
Indeterminant colitis
Axis 1 psychiatric comorbidities that prevent completion of informed consent
Inability to provide informed written consent
Protein losing enteropathy
Nephrotic syndrome
Liver disease
stage 4 or stage 5 chronic kidney disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Statistical methods / analysis
Power calculations have been completed and a sample size of 31 healthy controls and 62 patients with UC are required.

Descriptive statistics will be presented for characteristics of studied individuals.
Mean and standard deviation will be presented for normally distributed continuous variables, and median and interquartile ranges for skewed continuous variables.
Frequency and percentage will be used for categorical variables.
Relationships between energy and protein expenditure, body composition and disease state will be investigated using linear regression and mixed effects models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
26/06/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
93
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26498 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 42540 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 316156 0
University
Name [1] 316156 0
The University of Adelaide
Country [1] 316156 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 318590 0
None
Name [1] 318590 0
Address [1] 318590 0
Country [1] 318590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314986 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 314986 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 314986 0
Australia
Date submitted for ethics approval [1] 314986 0
29/06/2023
Approval date [1] 314986 0
11/07/2023
Ethics approval number [1] 314986 0
2023/HRE00114

Summary
Brief summary
This prospective cross sectional observational study aims to explore the protein and energy expenditure of patients with ulcerative colitis. Patients will undergo indirect calorimetry and nitrogen balance studies to determine their metabolic demand. The primary endpoint is nitrogen balance measured in nitrogen(g)/kg participant body weight/day. The secondary endpoint is resting metabolic rate in kcal/kg/day. Patient metabolic outputs will be compared to that of healthy controls. It is hypothesized that patients with ulcerative colitis do not have increased metabolic demands compared with healthy controls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133326 0
Ms Samantha Plush
Address 133326 0
The Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville south, SA, 5011
Country 133326 0
Australia
Phone 133326 0
+61 0401693177
Fax 133326 0
Email 133326 0
samantha.plush@sa.gov.au
Contact person for public queries
Name 133327 0
Samantha Plush
Address 133327 0
The Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville south, SA, 5011
Country 133327 0
Australia
Phone 133327 0
+61 0401693177
Fax 133327 0
Email 133327 0
samantha.plush@sa.gov.au
Contact person for scientific queries
Name 133328 0
Samantha Plush
Address 133328 0
The Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville south, SA, 5011
Country 133328 0
Australia
Phone 133328 0
+61 0401693177
Fax 133328 0
Email 133328 0
samantha.plush@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per ethics approval


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.