Quality of sleep in healthy adults with difficulty falling asleep or staying asleep Nervous System Diseases
Conditions
Interventions
Eighty healthy adults were planned to be randomized, with 40 participants randomized equally to Maizinol™ or placebo in a triple-blinded manner at a ratio of 1:1. Participants are instructed to take o
Sponsors
Unigen Inc
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males and females between 18 and 65 years of age, inclusive, at screening 2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of childbearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: 2.1. 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) 2.2. Double-barrier method 2.3. Intrauterine devices 2.4. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) 2.5. Vasectomy of partner at least 6 months prior to screening 3. Self-reported difficulty in falling asleep (taking longer than 30 minutes to fall asleep) or staying asleep, with two or more difficulty falling asleep/waking episodes in a 7-day period for at least one month 4. Agrees to maintain current lifestyle habits as much as possible throughout the run-in and study period depending on your ability to maintain the following: diet, medications, supplements, exercise, and avoid taking any new supplements 5. Agrees to stay in the current time zone for the duration of the run-in and study period 6. Agrees to refrain from herbal teas affecting sleep within 2 hours of bedtime, unless currently a part of their night routine for more than 30 days and willing to maintain that routine throughout the run-in and study period 7. Agrees to refrain from consuming caffeine and other stimulants, such as energy drinks, after 3:00 pm for the duration of the run-in and study period 8. Willingness to provide information related to COVID-19 infection/vaccination history 9. Willingness to complete study procedures, assessments, and all clinic visits associated with this study 10. Provided voluntary, written, informed consent to participate in the study 11. Healthy as determined by medical history and laboratory results as assessed by the QI
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, or intolerance to the IP or Placebo ingredients 3. Previous diagnosis of a sleep disorder or use of C-PAP 4. Menopausal women currently experiencing hot flashes 5. Current employment that calls for shiftwork or have worked shift work in the last three weeks 6. Travel across one or more time zones in the last two weeks prior to run-in 7. Currently experiencing vivid nightmares or sleepwalking 8. Unstable metabolic diseases or conditions known to cause disruptive sleep as assessed by the QI 9. Current or history of any significant psychiatric conditions, as assessed by the QI 10. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis 11. Unstable hypertension. Treatment on a stable dose of medication for at least three months will be considered by the QI 12. Type I diabetes 13. Type II diabetes with HbA1c = 7.5% 14. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least three months will be considered by the QI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in total sleep time, REM sleep time, deep sleep time, light sleep time, and awake duration are measured using an actigraphy and electroencephalogram (EEG) device from baseline at Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measures are assessed from baseline at Day 14: 1. Blood levels of serotonin measured using high-performance liquid chromatography, and melatonin and gamma-aminobutyric acid (GABA) measured using enzyme-linked immunosorbent assay (ELISA) 2. Clinically significant changes in vital signs (blood pressure [BP] and heart rate [HR]) measured manually or using an automatic blood pressure monitor/sphygmomanometer 3. Clinically significant changes in aspartate aminotransferase (AST), measured using IFCC without pyridoxal phosphate 4. Clinically significant changes in alanine aminotransferase (ALT), measured using a ALT catalysing reaction between L-alanine and 2-oxoglutarate. The pyruvate formed is reduced by NADH in a reaction catalyzed by lactate dehydrogenase (LDH) to form L-lactate and NAD+. 5. Clinically significant changes alkaline phosphatase (ALP), measured using a colorimetric assay 6. Clinically significant changes total bilirubin, measured using the colorimetric diazomethod 7. Clinically significant changes creatinine, measured using an enzymatic method 8. Clinically significant changes electrolytes (Na, K, Cl) measured using Indirect Ion-Selective Electrode 9. Clinically significant changes random glucose measured using a UV test, with enzymatic reference method with hexokinase 10. Clinically significant changes estimated glomerular filtration rate (eGFR) measured using The Chronic Kidney Disease Epidemiology Collaboration studies equation 11. Clinically significant changes in white blood cell (WBC) count with differential neutrophils, lymphocytes, monocytes, eosinophils, basophils, measured using Flow Cytometry Method using Semiconductor Laser 12. Clinically significant changes in red blood cell (RBC) count, platelet count, immature granulocytes, nucleated RBC, RBC indices (mean corpuscular volume [MCV], and red cell distribution width [RDW]), measured using Hydro Dynamic Focusing (DC Detection) - Impedance Counting. 13. Clinically significant chan | — |
Countries
Canada
Contacts
Public ContactErin Lewis
Outcome results
None listed