NCT05234593

Feasibility and Acceptability of Powdered Multinutrient Formula

Feasibility and Acceptability Study of a Powdered Multinutrient Formula in Children With Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 7 Years – 16 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EmpowerPlus Lightning Sticks	multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-02-02
• Completion: 2023-04-30
• First posted: 2022-02-10
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States