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CompletedNCT05234593Updated Apr 4, 2025

Feasibility and Acceptability of Powdered Multinutrient Formula

An interventional study of EmpowerPlus Lightning Sticks in Attention Deficit Hyperactivity Disorder, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
7 Years to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

Who can participate

Ages eligible
7 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age inclusive of and between 7 and 16 years at the time of enrollment
  2. Verbally willing to ingest one EmpowerPlus Lightning Stick daily
  3. Attend all virtual study appointments and complete questionnaires
  4. 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
  5. Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
  6. Willing to collect blood and urine samples, once, at home.

Exclusion criteria

Exclusion Criteria*:

  1. 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
  2. Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
  3. Known allergy to any ingredients of the intervention
  4. Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
  5. Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
  6. Any disability that would interfere with participant answering questions verbally
  7. Non-English speaking
  8. 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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Lightning Stick

    Feasibility and acceptability

    Dietary Supplement: EmpowerPlus Lightning Sticks

Interventions

  • Dietary supplementEmpowerPlus Lightning Sticks

    multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: week 6

  2. 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.

    Time frame: week 6

Secondary outcomes

  1. 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.

    Time frame: once, at baseline

  2. 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.

    Time frame: once, at baseline

  3. 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.

    Time frame: once, at baseline

  4. 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.

    Time frame: once, at baseline

  5. 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

    Time frame: week 6

  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

    Time frame: week 6

  7. 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).

    Time frame: week 6

06

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05234593
Lead sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Jeanette Johnstone (Associate Professor, Oregon Health and Science University) — Principal investigator
First posted
Feb 10, 2022
Start date
Aug 1, 2022
Primary completion
Feb 2, 2023
Completion
Apr 30, 2023
Last update
Apr 4, 2025

Study contacts

Jeanette Johnstone, PhD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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