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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.
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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.
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Secondary ID [1]
314178
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD)
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Condition category
Condition code
Neurological
333748
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330984
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Treatment: Other
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Comparator / control treatment
Participants in the placebo control condition will take gel-capsules containing an inert powder (e.g., corn powder).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Sustained Concentration
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Assessment method [1]
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Conners Continuous Performance Test (CPT)
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Timepoint [1]
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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).
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Secondary outcome [1]
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Acceptability of the intervention.
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Assessment method [1]
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Participant Feedback Questionnaire
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Timepoint [1]
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At intervention end-point (Day 14)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/06/2025
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Actual
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Date of last participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last data collection
Anticipated
31/10/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Auckland
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Address [1]
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Dr Rebecca Slykerman (Principal Investigator) the University of Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
321124
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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18/11/2024
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Approval date [1]
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01/04/2025
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Ethics approval number [1]
317304
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Summary
Brief summary
This feasibility study aims to explore the effects of 14 days of high-dose, multi-strand probiotic supplementation on mood and cognition in people with symptoms of ADHD, when taken with two different combinations of prebiotic and amino acid ingredients, compared to a placebo. The study will be exploratory with the following objectives: 1. To assess the tolerability and acceptability of the supplement combinations and placebo; 2. To assess the feasibility of trial processes including recruitment procedures and outcome measures; 3. To explore the effects of a single dose of two combinations of dietary supplements on attention, executive functioning, and mood state with the effects of a placebo; 4. To explore the effects of 14 days of twice-daily dosing of two combinations of dietary supplements on attention, executive functioning, and mood state with the effects of a placebo.
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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 Rebecca Slykerman
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Address
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Department of Psychological Medicine, University of Auckland, Level 3, Room 3033, Building 507, 22-30 Park Rd Grafton, Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 923 1132
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Rebecca Slykerman
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Address
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Department of Psychological Medicine, University of Auckland, Level 3, Room 3033, Building 507, 22-30 Park Rd Grafton, Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 923 1132
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Rebecca Slykerman
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Address
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Department of Psychological Medicine, University of Auckland, Level 3, Room 3033, Building 507, 22-30 Park Rd Grafton, Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 923 1132
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Fax
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Email
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[email protected]
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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.
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