Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001080415
Ethics application status
Approved
Date submitted
5/09/2025
Date registered
3/10/2025
Date last updated
3/10/2025
Date data sharing statement initially provided
3/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Hydrolysed Casein on Sleep, Stress and Mental Health in Young Adults
Scientific title
The Effects of Hydrolysed Casein on Sleep, Stress and Mental Health in Young Adults
Secondary ID [1] 315313 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 338780 0
Anxiety 338781 0
Depression 338782 0
Stress 338783 0
Condition category
Condition code
Mental Health 335074 335074 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral consumption of hydrolysed casein containing food bar (3g) daily for 5 weeks followed by two weeks wash out and another 5-week active phase. Adherence was assessed using a participant text messaging approach.
Intervention code [1] 331912 0
Treatment: Other
Comparator / control treatment
Oral consumption of skim milk powder containing food bar (3g) daily for 5 weeks
Control group
Active

Outcomes
Primary outcome [1] 342711 0
Change in sleep
Timepoint [1] 342711 0
Baseline, 2.5 weeks and 5 weeks post commencement for each arm, the primary timepoint is 5 weeks post commencement of each arm which is also the final timepoint.
Secondary outcome [1] 451875 0
Anxiety
Timepoint [1] 451875 0
Baseline, 2.5 weeks and 5 weeks post commencement for each arm
Secondary outcome [2] 451876 0
Depression
Timepoint [2] 451876 0
Baseline, 2.5 weeks and 5 weeks post commencement for each arm
Secondary outcome [3] 451877 0
Stress
Timepoint [3] 451877 0
Baseline, 2.5 weeks and 5 weeks post commencement for each arm,

Eligibility
Key inclusion criteria
The inclusion criteria for the study were adults aged between 20 and 35 years of age with existing low sleep quality. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), and individuals who scored > 5 were eligible to participate.
Minimum age
20 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included allergies to dairy, lactose intolerance, and a sleep deprivation score of < 5.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intervention bars were placed into sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/01/2024
Date of last participant enrolment
Anticipated
Actual
28/03/2024
Date of last data collection
Anticipated
Actual
30/08/2024
Sample size
Target
48
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 27334 0
New Zealand
State/province [1] 27334 0

Funding & Sponsors
Funding source category [1] 319886 0
Commercial sector/Industry
Name [1] 319886 0
Tatua Dairy Co-operative
Country [1] 319886 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 322416 0
Other Collaborative groups
Name [1] 322416 0
AgResearch
Address [1] 322416 0
Country [1] 322416 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318439 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 318439 0
Ethics committee country [1] 318439 0
New Zealand
Date submitted for ethics approval [1] 318439 0
02/10/2023
Approval date [1] 318439 0
31/12/2023
Ethics approval number [1] 318439 0
AHREC, Ref. AH26076

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144198 0
A/Prof Andrea Braakhuis
Address 144198 0
University of Auckland, 85 Park Road, Grafton, Auckland, 1142
Country 144198 0
New Zealand
Phone 144198 0
+64 223502926
Fax 144198 0
Email 144198 0
[email protected]
Contact person for public queries
Name 144199 0
Andrea Braakhuis
Address 144199 0
University of Auckland, 85 Park Road, Grafton, Auckland, 1142
Country 144199 0
New Zealand
Phone 144199 0
+64 223502926
Fax 144199 0
Email 144199 0
[email protected]
Contact person for scientific queries
Name 144200 0
Andrea Braakhuis
Address 144200 0
University of Auckland, 85 Park Road, Grafton, Auckland, 1142
Country 144200 0
New Zealand
Phone 144200 0
+64 223502926
Fax 144200 0
Email 144200 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 6 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.