Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sleep Quality, Sleep Health

Intervention / Treatment
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* Dietary Supplement: Sleep Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 before Cross Over<br>Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week. | Dietary Supplement: Sleep Supplement<br>* Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.<br>Dietary Supplement: Placebo<br>* Placebo product<br>|
| Experimental: Arm 2 after Cross Over<br>In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week. | Dietary Supplement: Sleep Supplement<br>* Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.<br>Dietary Supplement: Placebo<br>* Placebo product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva Melatonin level changes | Samples taken before bedtime at night and 2 hours after wakeup the next morning. A total of 8 samples were taken for each subject: (2) right after first washout, (2) right after Arm 1, (2) right after the second washout, (2) right after Arm 2. | 6 weeks | 
| Insomnia Severity Index Score | A scale used to measure the severity of insomnia. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Onset Latency | Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out. | 6 weeks | 
| Total Sleep Time | Total time a person spends asleep over a given night | 6 weeks | 
| Sleep Efficiency | Sleep efficiency is typically referring to the percentage of time a person spends asleep at night. To calculate this, you take a ratio of the total amount of time a person was asleep on a given night divided by the total amount of time they spent in bed, then multiply that by 100 to create a percentage. | 6 weeks | 
| Leeds Sleep Evaluation Questionnaire (LSEQ) Score | A 10-item, subjective, self-report measure, the LSEQ was designed to assess changes in sleep quality over the course of a psychopharmacological treatment intervention. The scale evaluates four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness. Total LSEQ Score ranges from 0 to 100, with 100 being the worst sleep quality and health overall. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Health, Sleep Quality, Melatonin, Lavender essential oil, GABA