Study to Assess Impact of Dietary Supplement on Sleep Health

NCT05971771 | Unknown

• 1 other identifier: DCS-7-23
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep

Keywords

Sleep; Alertness; Restfulness; Dietary AND Supplement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change from baseline perceived stress scale

  Baseline, Day 1, Day 7, Day 28

• Change from baseline Insomnia severity index

  Baseline, Day 1, Day 7, Day 28

• Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)

  Baseline, Day 1, Day 7, Day 28

• Change from baseline in mood

  Baseline, Day 1, Day 7, Day 28

• Change from baseline in skin attributes

  Baseline, Day 7, and Day 28

Other Outcomes (3)

• Change in diastolic blood pressure measurement (safety measure)

  Baseline and Day 28

• Change in systolic blood pressure measurement (safety measure)

  Baseline and Day 28

• Change in body weight

  Baseline and Day Day 28

Study Arms (2)

Active: Sleep Supplement containing Magnesium and Saffron Extract

EXPERIMENTAL

Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed

Dietary Supplement: Treatment

Placebo

PLACEBO COMPARATOR

Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed.

Other: Placebo

Interventions

Placebo OTHER

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

Also known as: Placebo Supplement

Placebo

Treatment DIETARY_SUPPLEMENT

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

Also known as: Supplement for supporting sleep

Active: Sleep Supplement containing Magnesium and Saffron Extract

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmanex: lead
• Dermatology Consulting Services, High Point NC: collaborator

MeSH Terms

Interventions

Therapeutics

Central Study Contacts

Zoe D Diana, MD

CONTACT

336-841-2040; zdraelos@northstate.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A double-blind, placebo controlled, parallel designed study in healthy subjects

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share