Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04093271
Other study ID # 18RSHL
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 24, 2019
Est. completion date December 23, 2019

Study information

Verified date November 2019
Source LifeSeasons Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 23, 2019
Est. primary completion date December 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: 1. Has given voluntary, written, informed consent to participate in the study 2. Males and females 25-65 years of age, inclusive 3. BMI of 18-32.5 kg/m2, inclusive 4. 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 5. 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 6. Healthy as determined by laboratory results and medical history and by QI assessment 7. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits 8. Agrees to maintain normal diet and exercise routine throughout the study 9. Agrees to maintain current sleep schedule throughout the study 10. Agrees to stay in the current time zone for the duration of the study 11. Agrees to refrain from herbal teas within 2 hours of bedtime, unless currently a part of their night routine for more than 30 days 12. Agrees to refrain from over-the-counter (OTC) products to help with sleep 13. Agrees to refrain from caffeine intake after 3:00 pm during the study 14. Agrees to comply with all study procedures Exclusion Criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial 2. Anticipated problems or allergies to any active or inactive ingredients in the investigational products as well as other flowers in the Asteraceae/Compositae family 3. Previous diagnosis of a sleep disorder or use of continuous positive air pressure (C-PAP) 4. Menopausal women with hot flashes 5. Registered with the Canadian National Institute for the Blind (CNIB) and considered as legally blind 6. Currently experiencing vivid nightmares or sleepwalking 7. 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 8. Chronic conditions such as asthma, heartburn, and migraines that consistently interfere with sleep 9. Controlled and uncontrolled hypo- and hypertension 10. Type I and Type II diabetes 11. Current employment that calls for shift work or have worked shift work in the last 3 weeks 12. Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel 13. Clinically significant abnormal laboratory results at screening 14. Use of prescribed medications or any other medications used to help with sleep 15. 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. 16. Evidence or history of clinically significant hematological, renal, endocrine, hepatic, and neurological diseases within the last 5 years as assessed by the QI 17. Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C-positive) 18. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow-up that is negative. Volunteers with cancer in full remission for more than 5 years after diagnosis are acceptable after review by QI 19. Diagnosis of any pineal gland abnormalities or have undergone pinealectomy 20. Diagnosis of lower gastrointestinal diseases such as irritable bowel syndrome and inflammatory bowel disease 21. Current or history of bleeding disorders 22. Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI 23. Tobacco use (cigarettes, e-cigarettes, vaporizers, etc.) within 90 days prior to baseline 24. Use of recreational marijuana within 30 days prior to baseline 25. High alcohol intake (average of >2 standard drinks per day or > 10 standard drinks per week) 26. Excessive habitual caffeine consumption (>2 cups coffee or >3 cups caffeinated tea or >2 energy drinks per day) or caffeine intake after 3:00 pm 27. Illicit drug use in the past 6 months as assessed by the QI 28. Participation in clinical trials within 30 days prior to enrollment 29. Blood donation will be assessed on a case-by case basis depending on frequency of donation and hematological and clinical chemistry parameters 30. History of any mental illness that might impair the ability of participants to provide written informed consent 31. Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures, or pose significant risk to the participant

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Rest-ZZZ
A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm
Drug:
Active Comparator - Diphenhydramine HCl
DIN 02229960 encapsulated for blinding purposes
Other:
Placebo
No active ingredients

Locations

Country Name City State
Canada KGK Science Inc. London Ontario

Sponsors (2)

Lead Sponsor Collaborator
LifeSeasons Inc. KGK Science Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other The incidence of adverse events (AEs) in the Rest-ZZZ, comparator, and placebo groups over the course of the study 7 days
Other 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
Other 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
Other The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on heart rate from pre-supplementation to Day 7 post-supplementation 7 days
Other The effect of supplementation with Rest-ZZZ formula, comparator, or placebo on weight from pre-supplementation to Day 7 post-supplementation 7 days
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1