Study to Assess Impact of Dietary Supplement on Sleep Health

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo Controlled, Single Center Pilot Study to Assess the Impact of Sleep Supplement on Sleep Health

Conditions
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Sleep

Intervention / Treatment
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* Other: Placebo
* Dietary Supplement: Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind, placebo controlled, parallel designed study in healthy subjects
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active: Sleep Supplement containing Magnesium and Saffron Extract<br>Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed | Dietary Supplement: Treatment<br>* 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<br>* Other names: Supplement for supporting sleep;|
| Placebo Comparator: Placebo<br>Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed. | Other: Placebo<br>* Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed<br>* Other names: Placebo Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline sleep quality index | Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality) | Baseline, Day 1, Day 7, Day 28 | 
| Change from baseline sleep duration and quality from diary | Change from baseline with Daily Sleep Diary | Baseline and Daily for 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline perceived stress scale | Change from baseline with validated perceived stress questionnaire | Baseline, Day 1, Day 7, Day 28 | 
| Change from baseline Insomnia severity index | Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia) | Baseline, Day 1, Day 7, Day 28 | 
| Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ) | Change from baseline using restorative sleep questionnaire as measured by Restorative Sleep Questionnaire (RSQ) that is a 9-item scale/question assessing symptoms over the last week. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep | Baseline, Day 1, Day 7, Day 28 | 
| Change from baseline in mood | Change from baseline using abbreviated Profile of Mood States (POMS) is a widely used questionnaire of 24 items and four scales. Total numbers range from 0-not at all to 4-very strong | Baseline, Day 1, Day 7, Day 28 | 
| Change from baseline in skin attributes | Change from baseline in skin attributes using 1-5 scale (1 strongly disagree to 5 strongly agree) with questionnaire regarding skin appearance (youthfulness, glow, evenness, hydration, etc) | Baseline, Day 7, and Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Alertness, Restfulness, Dietary AND Supplement