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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)
Scientific title
Evaluating change in the colonic luminal environment with protein supplementation in healthy adults (EAT PROTEIN)
Secondary ID [1] 312854 0
None
Universal Trial Number (UTN)
1111-1312-7414
Trial acronym
EAT-PROTEIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal health 334989 0
Condition category
Condition code
Oral and Gastrointestinal 331506 331506 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329399 0
Treatment: Other
Comparator / control treatment
The comparator is habitual diet
Control group
Active

Outcomes
Primary outcome [1] 339254 0
Volume of faecal hydrogen sulphide production between protein supplementation and habitual diet periods
Timepoint [1] 339254 0
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).
Secondary outcome [1] 439248 0
Weight status between protein supplementation and habitual diet periods
Timepoint [1] 439248 0
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).
Secondary outcome [2] 439249 0
Hand grip strength between protein supplementation and habitual diet periods
Timepoint [2] 439249 0
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).
Secondary outcome [3] 439250 0
Waist circumference between protein supplementation and habitual diet periods
Timepoint [3] 439250 0
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).
Secondary outcome [4] 439251 0
Faecal calprotectin between protein supplementation and habitual diet periods
Timepoint [4] 439251 0
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).
Secondary outcome [5] 439252 0
Metabolomics between protein supplementation and habitual diet periods
Timepoint [5] 439252 0
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).
Secondary outcome [6] 439254 0
Functional gastrointestinal symptom scores between protein supplementation and habitual diet periods
Timepoint [6] 439254 0
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).
Secondary outcome [7] 439255 0
Bowel habit between protein supplementation and habitual diet periods
Timepoint [7] 439255 0
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).
Secondary outcome [8] 439256 0
maintenance of habitual diet between protein supplementation and habitual diet periods
Timepoint [8] 439256 0
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).
Secondary outcome [9] 439257 0
Adherence to protein supplementation
Timepoint [9] 439257 0
end of week 1 (intervention period), end of week 2 (intervention period), end of week 7 (intervention period), end of week 8 (intervention period)
Secondary outcome [10] 439260 0
Tolerability of protein supplementation
Timepoint [10] 439260 0
end of week 1 (intervention period), end of week 2 (intervention period), end of week 7 (intervention period), end of week 8 (intervention period)
Secondary outcome [11] 439261 0
Safety via record of any adverse events
Timepoint [11] 439261 0
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
Secondary outcome [12] 440267 0
Microbial structure between protein supplementation and habitual diet periods
Timepoint [12] 440267 0
Baseline and end of week 2 (intervention)
Secondary outcome [13] 440268 0
Microbial diversity between protein supplementation and habitual diet periods
Timepoint [13] 440268 0
Baseline and end of week 2 (intervention period)
Secondary outcome [14] 440269 0
Microbial functional potential between protein supplementation and habitual diet periods
Timepoint [14] 440269 0
Baseline and end of week 2

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
5/05/2025
Actual
Date of last data collection
Anticipated
4/08/2025
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317298 0
Hospital
Name [1] 317298 0
The Queen Elizabeth Hospital
Country [1] 317298 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Country
Australia
Secondary sponsor category [1] 319579 0
None
Name [1] 319579 0
Address [1] 319579 0
Country [1] 319579 0
Other collaborator category [1] 283166 0
University
Name [1] 283166 0
The University of Adelaide
Address [1] 283166 0
Country [1] 283166 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316031 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316031 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 316031 0
Australia
Date submitted for ethics approval [1] 316031 0
20/09/2024
Approval date [1] 316031 0
Ethics approval number [1] 316031 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136562 0
Dr Alice Day
Address 136562 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
Country 136562 0
Australia
Phone 136562 0
+61 478267780
Fax 136562 0
Email 136562 0
[email protected]
Contact person for public queries
Name 136563 0
Ms Rachel Davis
Address 136563 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
Country 136563 0
Australia
Phone 136563 0
+61 478267780
Fax 136563 0
Email 136563 0
[email protected]
Contact person for scientific queries
Name 136564 0
Ms Rachel Davis
Address 136564 0
The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
Country 136564 0
Australia
Phone 136564 0
+61 478267780
Fax 136564 0
Email 136564 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
IPD will not be publicly 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.