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

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Quality, Sleep Health

In brief

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.

Key facts

Study ID

NCT05368909

Run by

4Life Research, LLC

People needed

30

Starts

2021-12-16

Expected to finish

2022-05-31

Last updated by the study team

2022-07-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 4Life Research — Sandy City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.