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

Sleep Quality Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05368909
• Other study ID #: 4Life-Sleep
• Status: Completed
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: 4Life Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Health
• Sleep Quality

Intervention

Dietary Supplement:
• Sleep Supplement
Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.
• Placebo
Placebo product

Locations

Country	Name	City	State
United States	4Life Research	Sandy	Utah

Sponsors (1)

Lead Sponsor	Collaborator
4Life Research, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Total Sleep Time	Total time a person spends asleep over a given night	6 weeks
Secondary	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
Secondary	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