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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rest-ZZZ | Dietary Supplement | A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The quality of life questionnaire will be used to measure discomfort and feelings of well being. This questionnaire has 31 questions assessing different areas in quality of life with various scales. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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:
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
Agrees to stay in the current time zone for the duration of the study
Agrees to refrain from herbal teas within 2 hours of bedtime, unless currently a part of their night routine for more than 30 days
Agrees to refrain from over-the-counter (OTC) products to help with sleep
Agrees to refrain from caffeine intake after 3:00 pm during the study
Agrees to comply with all study procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
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| Active Comparator - Diphenhydramine HCl | Drug | DIN 02229960 encapsulated for blinding purposes |
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| Placebo | Other | No active ingredients |
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| 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 | The POMS index is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials including other exercise related studies. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Participants will be instructed by a clinic coordinator to respond to the questionnaire based on the past week. | 7 days |
| 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 |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on heart rate from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on weight from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on Body Mass Index (BMI) from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on alanine aminotransferase (ALT) levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on aspartate aminotransferase (AST) levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on total bilirubin levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on creatinine levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on sodium levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on potassium levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on chloride levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on hemoglobin levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on hematocrit levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on platelet count levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on mean platelet volume (MPV) levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on red blood cell (RBC) count levels in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on red blood cell (RBC) indices in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on red cell distribution width (RDW) in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on white blood cell (WBC) count in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on neutrophils in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on monocytes in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on eosinophils in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |
| The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on basophils in the blood from pre-supplementation to Day 7 post-supplementation | 7 days |