Study to Assess Impact of Dietary Supplement on Sleep Health

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Treatment; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoe D Diana, MD; Phone Number: 336-841-2040; Email: zdraelos@northstate.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diastolic blood pressure measurement (safety measure)	Change from baseline diastolic blood pressure changes using sphygmomanometer	Baseline and Day 28
Change in systolic blood pressure measurement (safety measure)	Change from baseline systolic blood pressure changes using sphygmomanometer	Baseline and Day 28
Change in body weight	change from baseline in body weight as measured in pounds	Baseline and Day Day 28

Collaborators and Investigators

• Sponsor: Pharmanex
• Collaborators: Dermatology Consulting Services, High Point NC

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Alertness; Restfulness; Dietary AND Supplement
• Other Study ID Numbers: DCS-7-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No