Study to Assess Impact of Dietary Supplement on Sleep Health

NCT ID: NCT05971771

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Treatment

Intervention Type: 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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Placebo

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

Intervention Type: OTHER

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo Supplement; Supplement for supporting sleep

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dermatology Consulting Services, High Point NC

OTHER

Sponsor Role: collaborator

Pharmanex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zoe D Diana, MD

Role: CONTACT

zdraelos@northstate.net

336-841-2040

Other Identifiers

DCS-7-23

Identifier Type: -

Identifier Source: org_study_id