Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000582459
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
4/06/2025
Date last updated
4/06/2025
Date data sharing statement initially provided
4/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Effects of Dietary Supplements on Mood and Cognition in People with Symptoms of Attention-Deficit Hyperactivity Disorder (ADHD): A Feasibility Study.
Scientific title
Investigating the Effects of Dietary Supplements on Mood and Cognition in People with Symptoms of Attention-Deficit Hyperactivity Disorder (ADHD): A Feasibility Study.
Secondary ID [1] 314178 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 337365 0
Condition category
Condition code
Neurological 333748 333748 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of three intervention conditions. They will receive one of two different combinations of encapsulated dietary supplement ingredients or a matched placebo control. Participants in the dietary supplement groups will receive a combination of probiotic and prebiotic ingredients plus either a single amino acid ingredient or a combination of two different amino acid ingredients. Participants will take the intervention products twice a day for 14 days.
Participants will be asked to complete feedback questionnaires on days 7 and 14 which will include questions about adherence. They will be asked to return unused capsules at the end of the trial.
Details of intervention ingredients will be provided on the ANZCTR registry at the end of IP assessment.
Intervention code [1] 330984 0
Treatment: Other
Comparator / control treatment
Participants in the placebo control condition will take gel-capsules containing an inert powder (e.g., corn powder).
Control group
Placebo

Outcomes
Primary outcome [1] 341332 0
Sustained Concentration
Timepoint [1] 341332 0
At baseline and following consumption of the first dose of encapsulated dietary supplement products (Day 1) and at intervention end following consumption of the dietary supplement products twice a day for 14 days (Day 14).
Secondary outcome [1] 447160 0
Acceptability of the intervention.
Timepoint [1] 447160 0
At intervention end-point (Day 14)

Eligibility
Key inclusion criteria
• Are 18 years or older,
• Have clinically significant ADHD symptoms
• Live in Auckland, New Zealand;
• Are able to provide written informed consent;
• Are able to read and write English;
• Have access to a computer and/or mobile phone for purposes of communication and data collection;
• Can attend the study site (Clinical Rooms at the University of Auckland, Grafton campus) for two, 2-3-hour trial procedures (on trial days 1 and 14);
• Can provide the names of any diagnosed illness, disease or conditions, and the names of any currently prescribed medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant;
• Breast-feeding and their infant has been diagnosed with Phenylketonuria (PKU);
• Currently taking prescribed stimulant medication for ADHD;
• Currently taking non-stimulant medication for ADHD;
• Currently taking prescribed antibiotic medications, or have taken them in the 4 weeks prior to the trial commencement date;
• Currently taking probiotic supplements, or have taken them in the 4-weeks prior to the trial commencement date;
• Diagnosed with any of the following health conditions: Phenylketonuria (PKU), diagnosed conditions involving low blood pressure or blood thinning problems, inflammatory bowel disease (e.g., Chron’s Disease and ulcerative colitis);
• Currently taking medications that may theoretically interact with one or more of the dietary supplement ingredients;
• They have another person in their household currently enrolled in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation was concealed from participants.
A central randomization procedure was conducted using a computer.
Randomized codes were then provided to the compounding company responsible for dispensing the encapsulated dietary and placebo products for the trial.
The compounding company developed an allocation schedule using the randomized codes.
The compounding company then shared the allocation schedule with a designated person at the University of Auckland (not on the research team) who will retain this information in confidence until data lock, ensuring that participants and researchers remain blind to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised via computer (1:1:1 ratio) to one of three trial groups using stratified block randomisation (using varying block sizes), and stratified by ethnicity (Maori, non-Maori). The randomisation sequence will be generated by the trial statistician, and centrally managed and concealed until the point of randomisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/06/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 27034 0
New Zealand
State/province [1] 27034 0
Auckland

Funding & Sponsors
Funding source category [1] 318695 0
University
Name [1] 318695 0
The University of Auckland
Country [1] 318695 0
New Zealand
Primary sponsor type
Individual
Name
Dr Rebecca Slykerman (Principal Investigator) the University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321124 0
None
Name [1] 321124 0
Address [1] 321124 0
Country [1] 321124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317304 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317304 0
Ethics committee country [1] 317304 0
New Zealand
Date submitted for ethics approval [1] 317304 0
18/11/2024
Approval date [1] 317304 0
01/04/2025
Ethics approval number [1] 317304 0

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

Contacts
Principal investigator
Name 140630 0
Dr Rebecca Slykerman
Address 140630 0
Department of Psychological Medicine, University of Auckland, Level 3, Room 3033, Building 507, 22-30 Park Rd Grafton, Auckland 1023
Country 140630 0
New Zealand
Phone 140630 0
+64 09 923 1132
Fax 140630 0
Email 140630 0
[email protected]
Contact person for public queries
Name 140631 0
Rebecca Slykerman
Address 140631 0
Department of Psychological Medicine, University of Auckland, Level 3, Room 3033, Building 507, 22-30 Park Rd Grafton, Auckland 1023
Country 140631 0
New Zealand
Phone 140631 0
+64 09 923 1132
Fax 140631 0
Email 140631 0
[email protected]
Contact person for scientific queries
Name 140632 0
Rebecca Slykerman
Address 140632 0
Department of Psychological Medicine, University of Auckland, Level 3, Room 3033, Building 507, 22-30 Park Rd Grafton, Auckland 1023
Country 140632 0
New Zealand
Phone 140632 0
+64 09 923 1132
Fax 140632 0
Email 140632 0
[email protected]

Data sharing statement
Will the study consider sharing 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.