Feasibility and Acceptability of Powdered Multinutrient Formula

NCT05234593 | Completed

• 1 other identifier: 23379
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  week 6

Secondary Outcomes (7)

• Feasibility measured by count of participants who provide blood using the Tasso device

  once, at baseline

• Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw

  once, at baseline

• Feasibility measured by count of participants who provide the dried urine sample

  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

  once, at baseline

• Feasibility of remote study visits measured by count of participants who complete all online remote study visits

  week 6

Study Arms (1)

Lightning Stick

OTHER

Feasibility and acceptability

Dietary Supplement: EmpowerPlus Lightning Sticks

Interventions

EmpowerPlus Lightning Sticks DIETARY_SUPPLEMENT

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

Lightning Stick

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jeanette Johnstone, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 10, 2022
• Study Start: August 1, 2022
• Primary Completion: February 2, 2023
• Study Completion: April 30, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)