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

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093271
• Other study ID #: 18RSHL
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy
• Sleep

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