Sleep
Conditions
Keywords
Sleep, Alertness, Restfulness, Dietary AND Supplement
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.
Interventions
OTHERPlacebo
Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed
DIETARY_SUPPLEMENTTreatment
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
Dermatology Consulting Services, High Point NC
Pharmanex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Products will be delivered in forms that it will not be discernable (to participant, investigator, or care provider) as to which product is active or placebo
Intervention model description
A double-blind, placebo controlled, parallel designed study in healthy subjects
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline sleep duration and quality from diary | Baseline and Daily for 28 days | Change from baseline with Daily Sleep Diary |
| Change from baseline sleep quality index | Baseline, Day 1, Day 7, Day 28 | Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Insomnia severity index | Baseline, Day 1, Day 7, Day 28 | Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia) |
| Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ) | Baseline, Day 1, Day 7, Day 28 | 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 |
| Change from baseline perceived stress scale | Baseline, Day 1, Day 7, Day 28 | Change from baseline with validated perceived stress questionnaire |
| Change from baseline in mood | Baseline, Day 1, Day 7, Day 28 | 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 |
| Change from baseline in skin attributes | Baseline, Day 7, and Day 28 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure measurement (safety measure) | Baseline and Day 28 | Change from baseline systolic blood pressure changes using sphygmomanometer |
| Change in diastolic blood pressure measurement (safety measure) | Baseline and Day 28 | Change from baseline diastolic blood pressure changes using sphygmomanometer |
| Change in body weight | Baseline and Day Day 28 | change from baseline in body weight as measured in pounds |
Contacts
Primary ContactZoe D Diana, MD
Outcome results
None listed