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Proprietary Blend And Melatonin for Depression (InTeNSS Trial)

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline after 30 days supplementation
Awards & highlights

InTeNSS Trial 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

InTeNSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 30 days supplementation
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after 30 days supplementation for reporting.

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 more

InTeNSS Trial 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

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Who is running the clinical trial?

Kemin Foods LCIndustry Sponsor
7 Previous Clinical Trials
447 Total Patients Enrolled
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,171 Total Patients Enrolled
21 Trials studying Depression
3,224 Patients Enrolled for Depression
Michael Grandner, PhDPrincipal InvestigatorUniversity of Arizona
1 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.
Recent research and studies
clinicaltrials.govStudy
Investigational Test of a New Sleep Supplement
Michael A. Grandner 2018. "Investigational Test of a New Sleep Supplement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03567343.
All > Melatonin
~14 spots leftby Apr 2025
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