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

4Life Research, LLC1 site in 1 country30 target enrollmentDecember 16, 2021

ConditionsSleep Quality Sleep Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Quality
Sponsor: 4Life Research, LLC
Enrollment: 30
Locations: 1
Primary Endpoint: Saliva Melatonin level changes
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 16, 2021

End Date

May 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

4Life Research, LLC

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Saliva Melatonin level changes

Time Frame: 6 weeks

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.

Insomnia Severity Index Score

Time Frame: 6 weeks

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)