A Study to Evaluate the Effects of a Supplement on the Side Effects Associated With Stimulant Medications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOutliers, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18-55 years
Currently prescribed stimulant medication for ADHD
Experiencing: sleep difficulty, irritability, anxiety, brain fog
Stable medication dose ≥3 months
Disqualifiers
Chronic conditions (e.g. cancer, mental illness)
Use of psychiatric medications besides stimulants
Pregnancy, breastfeeding, thyroid, liver, kidney conditions
Recent smokers or heavy alcohol use
Trial design
Design model
Parallel
Treatments tested in this trial
Stasis Daytime and Nighttime
Dietary supplementDaytime taken with stimulant medication and food. Nighttime taken 30 minutes before bedtime on an empty stomach.
Placebo
Dietary supplementMatched placebo product in taste and appearance.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Stasis SupplementExperimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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 32
Change in cortisol levels
Serum cortisol concentration measured via blood draw.
Time frame
Baseline and Month 3Secondary outcomes
1
Change in sleep quality
Sleep quality assessed via self-report questionnaire.
Time frame
Baseline, Month 1, Month 2, and Month 32
Change in irritability
Irritability assessed via self-report questionnaire.
Time frame
Baseline, Month 1, Month 2, and Month 33
Change in focus
Focus assessed via self-report questionnaire.
Time frame
Baseline, Month 1, Month 2, and Month 34
Change in sociability
Sociability assessed via self-report questionnaire.
Time frame
Baseline, Month 1, Month 2, and Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Outliers, Inc.
Lead sponsor
Citruslabs
Collaborator
Source ClinicalTrials.gov