This is a hybrid, two-arm, triple-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of the Stasis supplement on reducing oxidative stress, cortisol levels, and side effects associated with stimulant medications used for ADHD over a three-month period in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Daytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.
Matched placebo product in taste and appearance.
Citruslabs
Las Vegas, Nevada, United States
RECRUITINGChange in oxidative stress and cortisol levels as measured by hs-CRP, 8-OHdG
Measurement of oxidative stress and cortisol levels will be assessed using the following validated biomarkers: hs-CRP and serum cortisol from blood samples 8-hydroxy-2'-deoxyguanosine (8-OHdG) from urine samples
Time frame: Baseline and Month 3
Change in cortisol levels
Serum cortisol concentration measured via blood draw.
Time frame: Baseline and Month 3
Change in sleep quality
Sleep quality assessed via self-report questionnaire.
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in irritability
Irritability assessed via self-report questionnaire.
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in focus
Focus assessed via self-report questionnaire.
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in sociability
Sociability assessed via self-report questionnaire.
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in self-reported mood
Mood assessed via self-report questionnaire.
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in self-reported stress
Stress levels assessed via self-report questionnaire.
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Time frame: Baseline, Month 1, Month 2, and Month 3
Change in self-reported appetite
Appetite assessed via self-report questionnaire.
Time frame: Baseline, Month 1, Month 2, and Month 3
Change in blood levels of Vitamin C
Serum levels of Vitamin C measured via blood test.
Time frame: Baseline and Month 3
Change in blood levels of CoQ10
Serum levels of Coenzyme Q10 measured via blood test.
Time frame: Baseline and Month 3