Feasibility and Acceptability of Powdered Multinutrient Formula

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Dietary Supplement: EmpowerPlus Lightning Sticks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05234593

23379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 7 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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*:

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Lightning Stick

Other group

Description:

Feasibility and acceptability

Treatment:

Dietary Supplement: EmpowerPlus Lightning Sticks