Status:
COMPLETED
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
Lead Sponsor:
4Life Research, LLC
Conditions:
Sleep Quality
Sleep Health
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05368909
Start Date
December 16 2021
End Date
May 31 2022
Last Update
July 12 2022
Active Locations (1)
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1
4Life Research
Sandy City, Utah, United States, 84070