Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
NCT ID: NCT05368909
Last Updated: 2022-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-12-16
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Arm 1 before Cross Over
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.
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
Arm 2 after Cross Over
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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4Life Research, LLC
INDUSTRY
Responsible Party
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Locations
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4Life Research
Sandy City, Utah, United States
Countries
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Other Identifiers
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4Life-Sleep
Identifier Type: -
Identifier Source: org_study_id
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