Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep

NCT04093271 | Completed Phase 1

• 1 other identifier: 18RSHL
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a sleep. The study will have 3 study periods. During each study period, eligible participants will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison in sleep quality using a sleep quality questionnaire from pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes include the change in quality of life, profile of mood states (POMS), and safety outcomes such as vital signs, clinical chemistry and hematological markers

Conditions

Sleep; Healthy

Keywords

Sleep; Healthy; Rest-ZZZ; randomized controlled trial; RCT; dietary supplement; natural health product

Outcome Measures

Primary Outcomes (1)

• Comparison of change in sleep quality assessed by the sleep quality (SQ) questionnaire between Rest-ZZZ, comparator, and placebo from pre-supplementation to after 7 days of supplementation

  The SQ Questionnaire will provide an index for the following parameters: sleep efficiency, perceived sleep debt, and sleep difficulty. In the sleep difficulty section, there are 7 questions asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). There are 7 questions in the sleep-related quality of life asking participants to rate on a scale of 1 to 5 (1 = Strongly Disagree, 2 = Disagree, 3 = No Opinion, 4 = Agree, 5 = Strongly agree). In both cases, a higher score corresponds to more sleep difficulty and worse sleep-related quality of life (one question in the sleep-related quality of life section has reverse scoring).

  7 days

Secondary Outcomes (2)

• Comparison between Rest-ZZZ, comparator, and placebo in the change in quality of life assessed by a quality of life questionnaire from pre-supplementation to after 7 days of supplementation

  7 days

• Comparison between Rest-ZZZ, comparator, and placebo in the change in Profile of Mood States (POMS) questionnaire from pre-supplementation to after 7 of supplementation

  7 days

Other Outcomes (25)

• The incidence of adverse events (AEs) in the Rest-ZZZ, comparator, and placebo groups over the course of the study

  7 days

• The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on systolic blood pressure from pre-supplementation to Day 7 post-supplementation

  7 days

• The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on diastolic blood pressure from pre-supplementation to Day 7 post-supplementation

  7 days

Study Arms (3)

Randomized to consume Rest-ZZZ, comparator, then placebo

EXPERIMENTAL

Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume the Rest-ZZZ dietary supplement in Study Period 1, Comparator (Diphenhydramine HCl) in Study Period 2, and Placebo in Study Period 3.

Dietary Supplement: Rest-ZZZ; Drug: Active Comparator - Diphenhydramine HCl; Other: Placebo

Randomized to consume comparator, placebo, then Rest-ZZZ

EXPERIMENTAL

Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume the Comparator (Diphenhydramine HCl) in Study Period 1, Placebo in Study Period 2, and the Dietary Supplement, Rest-ZZZ in Study Period 3.

Dietary Supplement: Rest-ZZZ; Drug: Active Comparator - Diphenhydramine HCl; Other: Placebo

Randomized to consume placebo, Rest-ZZZ, then comparator

EXPERIMENTAL

Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Dietary Supplement, Rest-ZZZ in Study Period 2, and Comparator (Diphenhydramine HCl) in Study Period 3.

Dietary Supplement: Rest-ZZZ; Drug: Active Comparator - Diphenhydramine HCl; Other: Placebo

Interventions

Rest-ZZZ DIETARY_SUPPLEMENT

A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm

Randomized to consume Rest-ZZZ, comparator, then placebo; Randomized to consume comparator, placebo, then Rest-ZZZ; Randomized to consume placebo, Rest-ZZZ, then comparator

Active Comparator - Diphenhydramine HCl DRUG

DIN 02229960 encapsulated for blinding purposes

Randomized to consume Rest-ZZZ, comparator, then placebo; Randomized to consume comparator, placebo, then Rest-ZZZ; Randomized to consume placebo, Rest-ZZZ, then comparator

Placebo OTHER

No active ingredients

Randomized to consume Rest-ZZZ, comparator, then placebo; Randomized to consume comparator, placebo, then Rest-ZZZ; Randomized to consume placebo, Rest-ZZZ, then comparator

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has given voluntary, written, informed consent to participate in the study
• Males and females 25-65 years of age, inclusive
• BMI of 18-32.5 kg/m2, inclusive
• Difficulty in falling asleep (taking longer than 30 minutes to fall asleep) or staying asleep, with 2 or more waking episodes in a 7-day period for at least 2 weeks
• Females participant is not of child bearing potential, defined as females who have had a hysterectomy or bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) or,
• Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Healthy as determined by laboratory results and medical history and by QI assessment
• Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
• Agrees to maintain normal diet and exercise routine throughout the study
• Agrees to maintain current sleep schedule throughout the study

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
• Anticipated problems or allergies to any active or inactive ingredients in the investigational products as well as other flowers in the Asteraceae/Compositae family
• Previous diagnosis of a sleep disorder or use of continuous positive air pressure (C-PAP)
• Menopausal women with hot flashes
• Registered with the Canadian National Institute for the Blind (CNIB) and considered as legally blind
• Currently experiencing vivid nightmares or sleepwalking
• Have unstable medical conditions such as heart failure, pneumonia, chronic obstructive pulmonary disease (COPD), reflux/gastroesophageal reflux disease (GERD), restless leg syndrome, chronic pain, or disruptive sleep for medical reasons
• Chronic conditions such as asthma, heartburn, and migraines that consistently interfere with sleep
• Controlled and uncontrolled hypo- and hypertension
• Type I and Type II diabetes
• Current employment that calls for shift work or have worked shift work in the last 3 weeks
• Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel
• Clinically significant abnormal laboratory results at screening
• Use of prescribed medications or any other medications used to help with sleep
• Use of OTC medications, supplements, food, drinks or products similar to the comparator or Rest-ZZZ to help with sleep. Chamomile, passion flower, valerian root, lemon balm and hawthorn berry ingested as teas and part of daily routine may be included in the study. However, participants will be required to maintain their current routines of consumption until the completion of the study.

Sponsors & Collaborators

• LifeSeasons Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: September 24, 2019
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: March 2, 2021

Record last verified: 2019-11

Locations

CA (1)