Sleep
Conditions
Brief summary
This is a prospective randomized clinical study of 30 patients to evaluate a novel sleep supplement. This study will be evaluating the effectiveness of the supplement over a 2 month program. The study will assess the effects that the supplement has on a patient's sleep metrics and epigenetic age biomarkers.
Interventions
DIETARY_SUPPLEMENTCircadian Wellness sleep SL strip
Participants in the intervention group will be asked to begin Circadian Wellness sleep SL strip nightly for 30 days. Participants will continue the supplementation for the 30 days.
Sponsors
Circadian Wellness Corp
TruDiagnostic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Patients will be in the control group for 1 month and in the intervention group for one month
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women of any ethnicity. * Age Range - 16 - 65 * Patient must be able to comply with treatment plan and laboratory tests
Exclusion criteria
* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision * No immune system issues or immunodeficiency disease * No history of viral illness which could be reactivated by immune downregulation * Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) * Diagnosis of a transient ischemic attack in the 6 months prior to screening * Patients infected with hepatitis, C or HIV * Patients with Body Mass Index (BMI) \> 40 kg/m2 * Presence of active infection * Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study * Unable or unwilling to provide required blood sample for testing * As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial. * If the patient has previously used any products in a month prior to the start of the trial. * Known sleep disorder ie. obstructive sleep apnea * Presence of schizophrenia, bipolar disorder * Concurrent use of cannabis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epigenetic Age | Change from baseline to 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Sleep duration | change from baseline to 2 months |
Contacts
Primary ContactSanjeev Goel, MD
Backup ContactAnnie Prestrud
Outcome results
None listed