Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000880549
Ethics application status
Approved
Date submitted
4/07/2024
Date registered
19/07/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
What are the perceptions and attitudes of adults with ulcerative colitis toward protein supplements and are they consuming them?
Scientific title
Understanding the perceptions, attitudes and use of protein supplements amongst adults with ulcerative colitis
Secondary ID [1] 312320 0
None
Universal Trial Number (UTN)
U1111-1309-1335
Trial acronym
USE-PROTEIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ulcerative colitis 334074 0
Condition category
Condition code
Oral and Gastrointestinal 330748 330748 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An online survey will be used via a secure platform to collect data at a single time point. A study advertisement will contain a QR code that links to the survey website. The survey will take 10-20 minutes to complete. The study aims to understand the perceptions and attitudes of people with ulcerative colitis toward protein supplements. The survey will also obtain data on whether participants have consumed protein supplements within the last six months. For those indicating consumption, further data to characterise and describe their intake of protein supplements will be obtained.
Intervention code [1] 328794 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338510 0
Proportion (% of cohort) of adults with ulcerative colitis who have consumed any protein supplements within the last 6-months.
Timepoint [1] 338510 0
Single time point at survey completion.
Secondary outcome [1] 436210 0
Proportion (% of cohort) who have concurrently aimed to increase dietary protein intake from table foods/ fluids when taking protein supplements.
Timepoint [1] 436210 0
Single time point at survey completion.
Secondary outcome [2] 436211 0
Proportion (% of cohort) who consume animal-based protein supplements compared to plant-based protein supplements
Timepoint [2] 436211 0
Single time point at survey completion.
Secondary outcome [3] 436212 0
Proportion (% of cohort) who consume doses of protein supplements in line with manufacturer recommendations
Timepoint [3] 436212 0
Single time point at survey completion.
Secondary outcome [4] 436213 0
The diversity in protein type and source of protein supplements consumed in the cohort
Timepoint [4] 436213 0
Single time point at survey completion.
Secondary outcome [5] 436214 0
The frequency of consumption of protein supplements within the cohort
Timepoint [5] 436214 0
Single time point at survey completion.
Secondary outcome [6] 436215 0
The diversity in source of information regarding recommendations to commence protein supplementation
Timepoint [6] 436215 0
Single time point at survey completion.
Secondary outcome [7] 436216 0
Proportion (% of cohort) who perceive protein supplements to be beneficial for overall health
Timepoint [7] 436216 0
Single time point at survey completion.
Secondary outcome [8] 436217 0
Proportion (% of cohort) who perceive there to be any risks associated with protein supplements
Timepoint [8] 436217 0
Single time point at survey completion.
Secondary outcome [9] 436218 0
Proportion (% of cohort) who perceive consumption of protein supplements to produce gastrointestinal symptoms
Timepoint [9] 436218 0
Single time point at survey completion.

Eligibility
Key inclusion criteria
Adults aged 18 years and older with a self-confirmed diagnosis of ulcerative colitis via colonoscopy and biopsy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged less than 18 years old, people who do not have a diagnosis of ulcerative colitis. People who are unable to read and interpret English.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to analyse data. Categorical data will be expressed as frequency and percentage. Any qualitative data where text responses have been collected will be quantitatively grouped into categories for analysis and expressed as frequency and percentage. Tables and graphs will be used to display data.
No power calculation has been performed for this descriptive study as no data exists on the intake of protein supplements amongst adults with ulcerative colitis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26371 0
New Zealand
State/province [1] 26371 0
Country [2] 26372 0
United Kingdom
State/province [2] 26372 0

Funding & Sponsors
Funding source category [1] 316715 0
Hospital
Name [1] 316715 0
The Queen Elizabeth Hospital
Country [1] 316715 0
Australia
Funding source category [2] 316936 0
University
Name [2] 316936 0
The University of Adelaide
Country [2] 316936 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Country
Australia
Secondary sponsor category [1] 319117 0
None
Name [1] 319117 0
Address [1] 319117 0
Country [1] 319117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315491 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315491 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 315491 0
Australia
Date submitted for ethics approval [1] 315491 0
04/07/2024
Approval date [1] 315491 0
19/07/2024
Ethics approval number [1] 315491 0
19770

Summary
Brief summary
Diet has been identified as a risk factor in ulcerative colitis. Understanding the habitual diet of people with ulcerative colitis is therefore important. Protein supplementation has become increasingly popular to optimise dietary protein intakes across the general population however data on protein supplement use in ulcerative colitis has not been examined. It is hypothesised that people with ulcerative colitis are consuming protein supplements for perceived health benefits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134862 0
Miss Rachel Davis
Address 134862 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia
Country 134862 0
Australia
Phone 134862 0
+61478267780
Fax 134862 0
Email 134862 0
[email protected]
Contact person for public queries
Name 134863 0
Rachel Davis
Address 134863 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia
Country 134863 0
Australia
Phone 134863 0
+61478267780
Fax 134863 0
Email 134863 0
[email protected]
Contact person for scientific queries
Name 134864 0
Rachel Davis
Address 134864 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, 5011, South Australia
Country 134864 0
Australia
Phone 134864 0
+61478267780
Fax 134864 0
Email 134864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be publically available


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.