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

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

Tracking Information

• First Submitted Date: May 2, 2022
• First Posted Date: May 10, 2022
• Last Update Posted Date: July 12, 2022
• Actual Study Start Date: December 16, 2021
• Actual Primary Completion Date: March 28, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 6, 2022)

• 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.
• 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 6, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Sleep Quality
• Sleep Health

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.
• Dietary Supplement: Placebo
  Placebo product

Study Arms

• 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.
  Interventions:

  • Dietary Supplement: Sleep Supplement
  • Dietary Supplement: Placebo
• 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.
  Interventions:

  • Dietary Supplement: Sleep Supplement
  • Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2022): 30
• Original Estimated Enrollment (submitted: May 6, 2022): 36
• Actual Study Completion Date: May 31, 2022
• Actual Primary Completion Date: March 28, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05368909
• Other Study ID Numbers: 4Life-Sleep
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: 4Life Research, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: 4Life Research, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: 4Life Research, LLC
• Verification Date: July 2022