None listed
Conditions
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.
Interventions
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.
P
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.
Sponsors
Dr Rebecca Slykerman (Principal Investigator) the University of Auckland
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed