Attention Deficit Hyperactivity DisorderNCT05234593
Feasibility and Acceptability of Powdered Multinutrient Formula
A study testing EmpowerPlus Lightning Sticks in people with Attention Deficit Hyperactivity Disorder, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- EmpowerPlus Lightning Sticks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age inclusive of and between 7 and 16 years at the time of enrollment
- Verbally willing to ingest one EmpowerPlus Lightning Stick daily
- Attend all virtual study appointments and complete questionnaires
- Have been previously enrolled in a multinutrient study OR complete a screening to match with participants from that study in terms of age and symptoms of ADHD and emotional dysregulation
- Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
- Willing to collect blood and urine samples, once, at home.
Who cannot join
- Neurological disorder involving brain or other central function (e.g., history of, or suspected, intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition
- Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
- Known allergy to any ingredients of the intervention
- Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
- Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
- Any disability that would interfere with participant answering questions verbally
- Non-English speaking
- Pregnancy or sexually active at baseline. *Exclusion criteria will be based on parent/guardian report on child. If the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. Potential participants may be reviewed virtually by study physician in the case of any concerns about participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Feasibility and Acceptability Study of a Powdered Multinutrient Formula in Children With Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires.
Read the detailed description
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. A limited number of blood samples will be used to generate cytokine data to test the ability to detect these molecules from the Tasso device-collected plasma. Parent and child questionnaire responses will examined for signals of change, but no formal statistical comparisons will be performed. This study will inform us whether a larger efficacy study is possible in this population.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- EmpowerPlus Lightning Sticks
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpowerPlus Lightning SticksDietary supplement
multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue
| Study group | Role | What they receive |
|---|---|---|
| Lightning Stick | Other | Feasibility and acceptability Receives: Dietary Supplement: EmpowerPlus Lightning Sticks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured by count of remaining Sticks
Feasibility will be determined if consumption of one Lightning Stick daily is achieved when greater than or equal to 80% of provided Sticks were taken.
Measured by count of remaining (unused) Sticks.
Measured: week 6
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
Acceptability of taking the Lightning Sticks will be measure through 7 questions with a 6-point Likert-scale, (range: Strongly Disagree to Strongly Agree) Acceptability will be achieved if greater than or equal to 70% of children and parents report that taking powdered multinutrients is acceptable, at or above the Agree range.
Measured: week 6
Secondary outcomes (7)
Feasibility measured by count of participants who provide blood using the Tasso device
At-home collection of blood with the Tasso device will be considered feasible if greater than or equal to 70% of children provide the sample.
Measured: once, at baseline
Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the Tasso at-home collection method instead of going to a lab to provide the blood sample.
Measured: once, at baseline
Feasibility measured by count of participants who provide the dried urine sample
At-home collection of dried urine samples will be considered feasible if greater than or equal to 70% of children provide the sample.
Measured: once, at baseline
Acceptability measured by a 'yes' response to their preference of using the at-home dried urine sample collection method instead of a lab-based urine sample collection method
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the at-home dried urine collection method instead of going to a lab to provide the urine sample.
Measured: once, at baseline
Feasibility of remote study visits measured by count of participants who complete all online remote study visits
Feasibility will be determined if greater than or equal to 70% of parents/guardians complete all three remote visits
Measured: week 6
Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits
Acceptability will be measured if greater than or equal to 70% of parents state they preferred completing online remote study visits instead of in-person study visits
Measured: week 6
Monitor participants for side effects by count of 'yes' if listed symptoms are new or have increased in severity, using the question format from the Pediatric Adverse Events Rating Scale
Parent and child report of side effects, including: headache, dry mouth, sleep disruptions, nausea, irritability, fatigue, anxiety, changes in appetite, skin rash, migraines, and other (specify what symptom).
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Aug 2022
- Primary completion2 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jeanette Johnstone, Oregon Health and Science University
- Investigators
- Jeanette Johnstone, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234593
- Sponsor's protocol ID
- 23379
- Status last verified
- Apr 2025
- First submitted
- 19 Jan 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Study of a Powdered Multinutrient Formula in Children With Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation
- ClinicalTrials.gov ID
- NCT05234593
- Acronym / sponsor ID
- 23379
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires.
Detailed description
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. A limited number of blood samples will be used to generate cytokine data to test the ability to detect these molecules from the Tasso device-collected plasma. Parent and child questionnaire responses will examined for signals of change, but no formal statistical comparisons will be performed. This study will inform us whether a larger efficacy study is possible in this population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility
| Arm | Type | Receives |
|---|---|---|
| Lightning Stick | Other | Dietary Supplement: EmpowerPlus Lightning SticksFeasibility and acceptability |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age inclusive of and between 7 and 16 years at the time of enrollment
- Verbally willing to ingest one EmpowerPlus Lightning Stick daily
- Attend all virtual study appointments and complete questionnaires
- Have been previously enrolled in a multinutrient study OR complete a screening to match with participants from that study in terms of age and symptoms of ADHD and emotional dysregulation
- Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
Key exclusion criteria (8 listed)
- Neurological disorder involving brain or other central function (e.g., history of, or suspected, intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition
- Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
- Known allergy to any ingredients of the intervention
- Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
- Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpowerPlus Lightning Sticksmultinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue | Dietary supplement | Lightning Stick |
Primary outcome
Feasibility measured by count of remaining Sticks
Time frame: week 6
Feasibility will be determined if consumption of one Lightning Stick daily is achieved when greater than or equal to 80% of provided Sticks were taken. Measured by count of remaining (unused) Sticks.
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
Time frame: week 6
Acceptability of taking the Lightning Sticks will be measure through 7 questions with a 6-point Likert-scale, (range: Strongly Disagree to Strongly Agree) Acceptability will be achieved if greater than or equal to 70% of children and parents report that taking powdered multinutrients is acceptable, at or above the Agree range.
7 secondary outcomes
Feasibility measured by count of participants who provide blood using the Tasso device
Time frame: once, at baseline
Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw
Time frame: once, at baseline
Feasibility measured by count of participants who provide the dried urine sample
Time frame: once, at baseline
Acceptability measured by a 'yes' response to their preference of using the at-home dried urine sample collection method instead of a lab-based urine sample collection method
Time frame: once, at baseline
Feasibility of remote study visits measured by count of participants who complete all online remote study visits
Time frame: week 6
Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits
Time frame: week 6
Monitor participants for side effects by count of 'yes' if listed symptoms are new or have increased in severity, using the question format from the Pediatric Adverse Events Rating Scale
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanette Johnstone, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmpowerPlus Lightning Sticks in people with Attention Deficit Hyperactivity Disorder, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measured by count of remaining Sticks (time frame: week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.