Study to Assess Impact of Dietary Supplement on Sleep Health

NCT05971771 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-02

No results posted yet for this study

Summary

Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.

Conditions

  • Sleep

Interventions

OTHER

Placebo

Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed

DIETARY_SUPPLEMENT

Treatment

14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed

Sponsors & Collaborators

  • Dermatology Consulting Services, High Point NC

    collaborator OTHER
  • Pharmanex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-08-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971771 on ClinicalTrials.gov