Other
Proprietary Blend And Melatonin for Depression
N/A
Waitlist Available
Led By Michael Grandner, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is a male or female, 22-50 years of age, inclusive.
Subject is judged by the Investigator to be in general good health on the basis of medical history.
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upchange from baseline after 30 days supplementation
Awards & highlights
Study Summary
This study seeks to observe the effects of a proprietary spearmint extract and green tea blend on sleep quality and duration. The study observes the effect of the supplement regarding sleep quality, and mental health.
Eligible Conditions
- Depression
- Cognitive Functioning
- Sleep
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline after 30 days supplementation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 30 days supplementation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fitbit - Rapid Eye Movement (REM) Sleep
Sleep Diary- Sleep Latency
Secondary outcome measures
Fitbit - total sleep time
Fitbit- %Deep Sleep
Fitbit- %Light Sleep
+11 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: Proprietary Blend And MelatoninActive Control1 Intervention
Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the proprietary spearmint extract blend and 1 Mg of melatonin by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days.
Group II: Proprietary Spearmint Extract BlendActive Control1 Intervention
Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the Proprietary Spearmint Extract Blend blend by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days.
A subset of this group will undergo 2 overnight polysomnography studies
Group III: MelatoninActive Control1 Intervention
Subjects randomized into the active treatment group will be asked to consume 1 Mg of melatonin by mouth every night 30 mins before bed and complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days.
Group IV: ControlPlacebo Group1 Intervention
Subjects randomized into the active treatment group will be asked to consume 500 mg/day of the excipient, microcrystalline cellulose by mouth every night 30 mins before bed, complete a sleep diary upon waking and wear a Fitbit Charge 2 device for sleep monitoring for 30 days.
A subset of this group will undergo 2 overnight polysomnography studies
Find a site
Who is running the clinical trial?
Kemin Foods LCIndustry Sponsor
7 Previous Clinical Trials
447 Total Patients Enrolled
University of ArizonaLead Sponsor
495 Previous Clinical Trials
147,579 Total Patients Enrolled
20 Trials studying Depression
3,229 Patients Enrolled for Depression
Michael Grandner, PhDPrincipal Investigator
University of Arizona1 Previous Clinical Trials
200 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.