Clinical trial NCT05971771: Study to Assess Impact of Dietary Supplement on Sleep Health
Official title: A Randomized, Double-Blind, Placebo Controlled, Single Center Pilot Study to Assess the Impact of Sleep Supplement on Sleep Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Keywords: Sleep
Alertness
Restfulness
Dietary AND Supplement
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: Dermatology Consulting Services, High Point NC
First posted: 2023-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, placebo controlled, parallel designed study in healthy subjects
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* The subject is male or female 20-60 years of age at the time of informed consent.
* Recorded baseline BMI is ≥18.5 and ≤29.9 kg/m2.
* A score of 5 or higher on the Pittsburgh Sleep Quality Index.
* Willing and able to give informed consent
* Willing to maintain consistent diet and physical activity through the study period.
* Willing to limit alcohol consumption to ≤14 drinks per week, no more than 4 drinks at a time, and no more than 1 drink within 4h of bedtime.
* Willing to limit caffeine consumption to no more than 4 servings per day and no caffeine within 6h of bedtime.

Exclusion Criteria:

* Could not or did not want to participate in clinical study.
* Taken nutritional supplements for sleep or stress in the previous 6 months.
* Have received non-pharmacological treatment for sleep disorders (eg. Cognitive behavioral therapy, relation therapy) in previous 6 months
* Any known allergy or intolerance to any of the ingredients contained in supplement.
* Planned surgical procedure during the course of the study.
* Used nicotine in the past 6 months.
* Have a major psychiatric disorder as determined by the Mini International Neuropsychiatric Inventory
* A history of unconventional sleep pattern, a diagnosed sleep disorder, or chronic medical condition that could affect energy/fatigue levels.
* Consume more than 400mg of caffeine per day in the past 2 weeks.
* Used any psychotropic medications, stimulants, cannabis, non-registered drug products, or illicit substances in the past 4 weeks.
* At risk of drug or alcohol abuse
* Used any sleep aids in the past 2 weeks.
* Employed in night shift work or rotational shift work
* Currently pregnant, nursing, planning to become pregnant, or unwilling to use a medically approved form of contraception will be excluded.
* Individuals who sleep more than 10 hours.
* Typically take a nap during the day.
* Those planning travel or vacation during the study period.

Primary outcomes:
measure: Change from baseline sleep quality index
timeFrame: Baseline, Day 1, Day 7, Day 28
measure: Change from baseline sleep duration and quality from diary
timeFrame: Baseline and Daily for 28 days
Secondary outcomes:
measure: Change from baseline perceived stress scale
timeFrame: Baseline, Day 1, Day 7, Day 28
measure: Change from baseline Insomnia severity index
timeFrame: Baseline, Day 1, Day 7, Day 28
measure: Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)
timeFrame: Baseline, Day 1, Day 7, Day 28
measure: Change from baseline in mood
timeFrame: Baseline, Day 1, Day 7, Day 28
measure: Change from baseline in skin attributes
timeFrame: Baseline, Day 7, and Day 28
Other outcomes:
measure: Change in diastolic blood pressure measurement (safety measure)
timeFrame: Baseline and Day 28
measure: Change in systolic blood pressure measurement (safety measure)
timeFrame: Baseline and Day 28
measure: Change in body weight
timeFrame: Baseline and Day Day 28
Locations:
Study officials:
References: