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Trial record 1 of 1 for:    NCT05368909
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Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality

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ClinicalTrials.gov Identifier: NCT05368909
Recruitment Status : Completed
First Posted : May 10, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
4Life Research, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Quality Sleep Health Dietary Supplement: Sleep Supplement Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 16, 2021
Actual Primary Completion Date : March 28, 2022
Actual Study Completion Date : May 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Sleep Supplement
Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.

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

Dietary Supplement: Placebo
Placebo product


Outcome Measures
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Primary Outcome Measures :
  1. Saliva Melatonin level changes [ Time Frame: 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.

  2. Insomnia Severity Index Score [ Time Frame: 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 :
  1. Sleep Onset Latency [ Time Frame: 6 weeks ]
    Sleep latency, or sleep onset latency, is the time it takes a person to fall asleep after turning the lights out.

  2. Total Sleep Time [ Time Frame: 6 weeks ]
    Total time a person spends asleep over a given night

  3. Sleep Efficiency [ Time Frame: 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.

  4. Leeds Sleep Evaluation Questionnaire (LSEQ) Score [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368909


Locations
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United States, Utah
4Life Research
Sandy, Utah, United States, 84070
Sponsors and Collaborators
4Life Research, LLC
More Information
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Responsible Party: 4Life Research, LLC
ClinicalTrials.gov Identifier: NCT05368909    
Other Study ID Numbers: 4Life-Sleep
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 4Life Research, LLC:
Sleep Health
Sleep Quality
Melatonin
Lavender essential oil
GABA