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

NCT05368909 | Completed

• 1 other identifier: 4Life-Sleep
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality; Sleep Health

Keywords

Sleep Health; Sleep Quality; Melatonin; Lavender essential oil; GABA

Outcome Measures

Primary Outcomes (2)

• Saliva Melatonin level changes

  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.

  6 weeks

• Insomnia Severity Index Score

  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)

  6 weeks

Secondary Outcomes (4)

• Sleep Onset Latency

  6 weeks

• Total Sleep Time

  6 weeks

• Sleep Efficiency

  6 weeks

• Leeds Sleep Evaluation Questionnaire (LSEQ) Score

  6 weeks

Study Arms (2)

Arm 1 before Cross Over

EXPERIMENTAL

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; Dietary Supplement: Placebo

Arm 2 after Cross Over

EXPERIMENTAL

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; Dietary Supplement: Placebo

Interventions

Sleep Supplement DIETARY_SUPPLEMENT

Proprietary sleep formula containing Tri Factor, Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) and Magnesium.

Arm 1 before Cross Over; Arm 2 after Cross Over

Placebo DIETARY_SUPPLEMENT

Placebo product

Arm 1 before Cross Over; Arm 2 after Cross Over

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• 4Life Research, LLC: lead

Study Sites (1)

4Life Research

Sandy City, Utah, 84070, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 10, 2022
• Study Start: December 16, 2021
• Primary Completion: March 28, 2022
• Study Completion: May 31, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)