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Trial registered on ANZCTR
Registration number
ACTRN12624001270505p
Ethics application status
Submitted, not yet approved
Date submitted
24/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluating change in the colonic luminal environment with protein supplementation (EAT PROTEIN)
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Scientific title
Evaluating change in the colonic luminal environment with protein supplementation in healthy adults (EAT PROTEIN)
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Secondary ID [1]
312854
0
None
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Universal Trial Number (UTN)
1111-1312-7414
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Trial acronym
EAT-PROTEIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal health
334989
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Condition category
Condition code
Oral and Gastrointestinal
331506
331506
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention in this trial is protein supplementation. The intervention will be provided in the form of "ingredient sachets" which will be developed in a research/commercial level kitchen. The protein-based ingredient sachets will contain 30g of whey protein isolate and 20g of full cream milk powder. Participants will consume three ingredient sachets per day, during the intervention weeks, incorporating them into their habitual diet by making into drinks or adding to food items. All participants will have two weeks of protein supplementation, followed by four weeks of habitual diet, followed by two weeks of protein supplementation (counterbalanced design). Participants will receive education from a research dietitian at a face-to-face 1-hour appointment at the hospital clinic. The education will be tailored to their individual diet to assist with adherence and to ensure maintenance of isocaloric intake to their habitual diet. Participants will also receive a supplementation guide developed for the purpose of this study, providing ideas of how to prepare the ingredient sachets. Adherence will be assessed via self-reported questionnaire indicating number of non-adherent days and confirmed by participants returning their supplement packaging.
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Intervention code [1]
329399
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Treatment: Other
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Comparator / control treatment
The comparator is habitual diet
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Control group
Active
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Outcomes
Primary outcome [1]
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Volume of faecal hydrogen sulphide production between protein supplementation and habitual diet periods
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Assessment method [1]
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Measured using a colourimetric assay of fresh stool sample
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Timepoint [1]
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Baseline, end of week 1 (intervention period), end of week 2 (intervention period), end of week 3 (habitual diet period), end of week 4 (habitual diet period), end of week 5 (habitual diet period), end of week 6 (habitual diet period), end of week 7 (intervention period), end of week 8 (intervention period).
Primary time points for analysis of primary outcome are volume produced at baseline, compared to end of week 2 (intervention period), compared to end of week 4 (habitual diet period), compared to end of week 6 (habitual diet period), compared to end of week 8 (intervention period).
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Secondary outcome [1]
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Weight status between protein supplementation and habitual diet periods
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Assessment method [1]
439248
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scales
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Timepoint [1]
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Baseline, end of week 2 (intervention period), end of week 4 (habitual diet period), end of week 6 (habitual diet period), end of week 8 (intervention period).
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Secondary outcome [2]
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Hand grip strength between protein supplementation and habitual diet periods
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Assessment method [2]
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Dynamometer
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Timepoint [2]
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Baseline, end of week 2 (intervention period), end of week 4 (habitual diet period), end of week 6 (habitual diet period), end of week 8 (intervention period).
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Secondary outcome [3]
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Waist circumference between protein supplementation and habitual diet periods
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Assessment method [3]
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Tape measure
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Timepoint [3]
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Baseline, end of week 2 (intervention period), end of week 4 (habitual diet period), end of week 6 (habitual diet period), end of week 8 (intervention period).
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Secondary outcome [4]
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Faecal calprotectin between protein supplementation and habitual diet periods
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Assessment method [4]
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Faecal sampling - standard pathology services
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Timepoint [4]
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Baseline, end of week 2 (intervention period), end of week 4 (habitual diet period), end of week 6 (habitual diet period), end of week 8 (intervention period).
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Secondary outcome [5]
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Metabolomics between protein supplementation and habitual diet periods
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Assessment method [5]
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faecal and urinary sulphur compounds, nitrogenous compounds, short and branched chain fatty acids from fresh stool and urine samples
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Timepoint [5]
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Baseline, end of week 1 (intervention period), end of week 2 (intervention period), end of week 3 (habitual diet period), end of week 4 (habitual diet period), end of week 5 (habitual diet period), end of week 6 (habitual diet period), end of week 7 (intervention period), end of week 8 (intervention period).
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Secondary outcome [6]
439254
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Functional gastrointestinal symptom scores between protein supplementation and habitual diet periods
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Assessment method [6]
439254
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gastrointestinal symptom rating scale - irritable bowel syndrome questionnaire (GSRS-IBS)
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Timepoint [6]
439254
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Baseline, end of week 1 (intervention period), end of week 2 (intervention period), end of week 3 (habitual diet period), end of week 4 (habitual diet period), end of week 5 (habitual diet period), end of week 6 (habitual diet period), end of week 7 (intervention period), end of week 8 (intervention period).
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Secondary outcome [7]
439255
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Bowel habit between protein supplementation and habitual diet periods
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Assessment method [7]
439255
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Self-completed questionnaire designed specifically for this study of stool frequency, consistency (reference to the Bristol stool chart) and odour (visual analogue scale).
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Timepoint [7]
439255
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Baseline, end of week 1 (intervention period), end of week 2 (intervention period), end of week 3 (habitual diet period), end of week 4 (habitual diet period), end of week 5 (habitual diet period), end of week 6 (habitual diet period), end of week 7 (intervention period), end of week 8 (intervention period).
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Secondary outcome [8]
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maintenance of habitual diet between protein supplementation and habitual diet periods
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Assessment method [8]
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3-day weighed food diary
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Timepoint [8]
439256
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Baseline, end of week 1 (intervention period), end of week 2 (intervention period), end of week 3 (habitual diet period), end of week 4 (habitual diet period), end of week 5 (habitual diet period), end of week 6 (habitual diet period), end of week 7 (intervention period), end of week 8 (intervention period).
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Secondary outcome [9]
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Adherence to protein supplementation
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Assessment method [9]
439257
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self-completed questionnaire designed specifically for this study and return of supplement packaging
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Timepoint [9]
439257
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end of week 1 (intervention period), end of week 2 (intervention period), end of week 7 (intervention period), end of week 8 (intervention period)
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Secondary outcome [10]
439260
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Tolerability of protein supplementation
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Assessment method [10]
439260
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100-mm visual analogue scale (0= extremely intolerable and 100= extremely tolerable)
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Timepoint [10]
439260
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end of week 1 (intervention period), end of week 2 (intervention period), end of week 7 (intervention period), end of week 8 (intervention period)
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Secondary outcome [11]
439261
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Safety via record of any adverse events
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Assessment method [11]
439261
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Adverse events reporting form designed specifically for this study- possible adverse events include gastrointestinal disturbances (captured in other outcomes), headaches or halitosis
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Timepoint [11]
439261
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end of week 1, end of week 2, end of week 3, end of week 4, end of week 5, end of week 6, end of week 7, end of week 8
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Secondary outcome [12]
440267
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Microbial structure between protein supplementation and habitual diet periods
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Assessment method [12]
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Metagenomic sequencing and bioinformatics - DNA extraction from fresh stool
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Timepoint [12]
440267
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Baseline and end of week 2 (intervention)
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Secondary outcome [13]
440268
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Microbial diversity between protein supplementation and habitual diet periods
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Assessment method [13]
440268
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Metagenomic sequencing and bioinformatics - DNA extraction from stool
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Timepoint [13]
440268
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Baseline and end of week 2 (intervention period)
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Secondary outcome [14]
440269
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Microbial functional potential between protein supplementation and habitual diet periods
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Assessment method [14]
440269
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Metagenomic sequencing and bioinformatics - DNA extraction from fresh stool
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Timepoint [14]
440269
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Baseline and end of week 2
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Eligibility
Key inclusion criteria
Healthy adult males aged 18 years or older who are able to provide informed consent and willing to consume animal-based protein supplemented ingredient sachets
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Female sex, aged less than 18 years of age.
Any previous gastrointestinal surgery and diagnosis of any gastrointestinal disorders.
Diagnosis of any chronic renal or liver failure.
Significant psychiatric or cognitive co-morbidities or unable to provide informed consent.
Diagnosis of cows milk protein allergy, soy allergy or lactose intolerance.
Individuals currently enrolled in another clinical trial.
Washout periods required for:
- no protein supplementation in the past 2 weeks before trial commencement.
- no medications that alter bowel habit in the past 2 weeks before trial commencement (laxatives, probiotics, opioids, anti-emetics)
- no antibiotics or corticosteroids for any infection or other medical reason in the past 4 weeks
- no COVID-19 infection in the past 4 weeks
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
This study will be a series of N-of-1 trials. Four participants will be recruited to this study based on what is feasible for this project. The aim of N-of-1 trials is to determine the effect of the intervention at the intervention level therefore it is not necessary to protect against a false-positive decision as in standard hypothesis testing used in clinical trials. However, to estimate the population average effect a total of n=16 would be needed to participate in a cross over study. The sample size would provide 80% power with a two-sided 5% alpha and correlation of 0.5 to detect a mean difference of 58ppm/g in faecal hydrogen sulphide production between groups whilst allowing for a 10% drop out. A standard deviation of 68.5 is derived from the 95% confidence interval (16, 97) of median difference in hydrogen sulphide production between two groups. Number of time points in N-of-1 trials correspond to what the number of participants is in a cross-over trial when considering sample. Therefore, with N=4 participants recruited and N=9 time points, this equates to an overall sample size for analysis of N=36.
Time series analysis and linear mixed effects models will be performed for continuous variables at the individual N-of-1 trial level. Meta-analysis will be performed to combine data from each N-of-1 trial. Descriptive statistics will be used for categorical variables.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
5/05/2025
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Actual
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Date of last data collection
Anticipated
4/08/2025
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Actual
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Sample size
Target
4
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
317298
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Hospital
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Name [1]
317298
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The Queen Elizabeth Hospital
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Address [1]
317298
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Country [1]
317298
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Australia
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Primary sponsor type
Hospital
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Name
The Queen Elizabeth Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319579
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Address [1]
319579
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Country [1]
319579
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Other collaborator category [1]
283166
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University
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Name [1]
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The University of Adelaide
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Address [1]
283166
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Country [1]
283166
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316031
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
316031
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
316031
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Australia
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Date submitted for ethics approval [1]
316031
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20/09/2024
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Approval date [1]
316031
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Ethics approval number [1]
316031
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Summary
Brief summary
The purpose of this study is to determine the effect of protein-supplementation on faecal hydrogen sulphide production in healthy adult males. We hypothesise that protein supplementation will altern the colonic microbial environment but be safe, tolerable and adhered to by healthy adult males.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Alice Day
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Address
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The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
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Country
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Australia
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Phone
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+61 478267780
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Fax
136562
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Email
136562
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[email protected]
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Contact person for public queries
Name
136563
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Ms Rachel Davis
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Address
136563
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The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
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Country
136563
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Australia
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Phone
136563
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+61 478267780
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Fax
136563
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Email
136563
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[email protected]
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Contact person for scientific queries
Name
136564
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Ms Rachel Davis
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Address
136564
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The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
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Country
136564
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Australia
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Phone
136564
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+61 478267780
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Fax
136564
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Email
136564
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD will not be publicly available
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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.
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