Sleep
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and superiority of a botanical based sleep product on sleep quality as compared to melatonin, among healthy female participants.
Interventions
DIETARY_SUPPLEMENTProprietary Blend of Botanical Extracts
Participants consumed 2.4ml of the supplement each night before bed.
DIETARY_SUPPLEMENTMelatonin
Participants consumed 1mg melatonin each night before bed.
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Provision of signed and dated informed consent form Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study Self reported poor sleep quality Biological sex of woman; gender identification of female Aged 35 to 55, inclusive Good general health as evidenced by medical history and screening For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study Has an apple watch or similar device Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion criteria
Pregnancy, trying to conceive, or breastfeeding Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year Has received medical diagnosis or treatment for any sleep disorder in the past year Has ever received a medical diagnosis of sleep apnea or narcolepsy Works a night shift, is on-call or performs any job requiring or potentially requiring work related responsibilities after 8pm Consumes \> 8 alcoholic beverages in an average week Is a primary caretaker for a child younger than 18 months of age Consumes any sleep aid, medication, diet, or supplement intended to improve sleep in any way Known allergic reactions to any components of the intervention Positive COVID-19 test within 30 days of the study period Recent dramatic weight changes (10% change in body weight in the last 6 months) Introducing a new investigational drug or other intervention within 60 days before the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRI Sleep Scale | From baseline to the end of the 28 day intervention. | The NRI Sleep Scale is a validated measure of sleep health. It has 6 domains, each measured on a Likert scale, with higher scores indicating greater sleep disturbances. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wearable Technology | From baseline to the end of the 28 day intervention. | Sleep data sourced from the participant's Apple Watch (time in bed, time spent per phase (awake, REM, core, and deep). |
| NRI Energy Scale | From baseline to the end of the 28 day intervention. | Description: The NRI Energy Scale is a validated measure of fatigue. It has 7 domains, each measured on a Likert scale, with higher scores indicating greater fatigue. |
Countries
United States
Outcome results
None listed