Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
- Conditions
- Sleep HealthSleep Quality
- Interventions
- Dietary Supplement: Sleep SupplementDietary Supplement: Placebo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
- Arm && Interventions
Group Intervention Description Arm 2 after Cross Over Sleep Supplement In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week. Arm 2 after Cross Over Placebo In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week. Arm 1 before Cross Over Placebo Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week. Arm 1 before Cross Over Sleep Supplement Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week.
- 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