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Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep

Healthy Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep

Clinical Trial Summary

A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a sleep. The study will have 3 study periods. During each study period, eligible participants will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison in sleep quality using a sleep quality questionnaire from pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes include the change in quality of life, profile of mood states (POMS), and safety outcomes such as vital signs, clinical chemistry and hematological markers

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04093271
Study type Interventional
Source LifeSeasons Inc.
Contact
Status Completed
Phase Phase 1
Start date September 24, 2019
Completion date December 23, 2019
View Details
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