Clinical trial NCT05368909: Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
Official title: Assessment of the Effects of a Dietary Supplement on the Sleep Health and Sleep Quality of People With Sleep Problems: A Randomized, Double-blind, Placebo-controlled, Crossover Design Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Sleep Health
Keywords: Sleep Health
Sleep Quality
Melatonin
Lavender essential oil
GABA
Lead sponsor: 4Life Research, LLC
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.


Eligibility criteria: Inclusion Criteria:

* Non-smokers
* Judged by the Investigator to be in general good health on the basis of medical history
* Willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or Rx sleep aids for the duration of the study
* Insomnia Severity Index score of ≥ 8
* Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study

Exclusion Criteria:

* Pregnant and/or lactating women
* Known allergy or adverse reaction to ingredients in the product: Tri Factor (bovine colostrum and egg yolk extracts), Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) or Magnesium
* Prescription sedative or psychoactive (including anti-depressant) medication use
* Diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history
* A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
* Routine consumption of more than 2 alcoholic beverages per day or consumption of caffeine past 2 PM for the duration of the study
* Illicit drug use
* Use of prescription stimulants (modafinil, dextroamphetamine, etc.)
* Use of prescription medications known to affect sleep (antidepressants, anti-anxiety, opioids, alpha-blockers, beta-blockers, corticosteroids, ACE inhibitors, angiotensin II-receptor blockers, cholinesterase inhibitors, allergy medication, asthma medication, glucosamine and chondroitin, statins, anti-smoking or thyroid medication, muscle relaxants, anticonvulsants)
* Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 10th grade reading level; visual, hearing or upper extremity motor deficit
* Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months
* Unwilling to consume or unable to swallow capsules/tablets
* Previous exposure to this product in earlier testing phases

Primary outcomes:
measure: Saliva Melatonin level changes
timeFrame: 6 weeks
measure: Insomnia Severity Index Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Sleep Onset Latency
timeFrame: 6 weeks
measure: Total Sleep Time
timeFrame: 6 weeks
measure: Sleep Efficiency
timeFrame: 6 weeks
measure: Leeds Sleep Evaluation Questionnaire (LSEQ) Score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sandy
country: United States
facility: 4Life Research
state: Utah
Study officials:
References: