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

Not Applicable

Completed

• Conditions: Sleep Health; Sleep Quality

• Registration Number: NCT05368909
• Lead Sponsor: 4Life Research, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-16
• Primary Completion: 2022-03-28
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Saliva Melatonin level changes	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	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)

Secondary Outcome Measures

Name	Time	Method
Sleep Onset Latency	6 weeks	Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.
Total Sleep Time	6 weeks	Total time a person spends asleep over a given night
Leeds Sleep Evaluation Questionnaire (LSEQ) Score	6 weeks	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.
Sleep Efficiency	6 weeks	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.

Trial Locations

Locations (1)

4Life Research; 🇺🇸 Sandy, Utah, United States