Clinical Efficacy of a Supplement on Sleep Quality

Sleep Clinical Trial

Official title:

Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04988542
• Other study ID #: TD-SQ-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: TruDiagnostic
• Contact: Sanjeev Goel, MD
• Phone: 647-966-4385
• Email: DRGOEL[@]PEAKHUMAN.CA
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Circadian 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
TruDiagnostic	Circadian Wellness Corp

References & Publications (1)

Cui XY, Cui SY, Zhang J, Wang ZJ, Yu B, Sheng ZF, Zhang XQ, Zhang YH. Extract of Ganoderma lucidum prolongs sleep time in rats. J Ethnopharmacol. 2012 Feb 15;139(3):796-800. doi: 10.1016/j.jep.2011.12.020. Epub 2011 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetic Age		Change from baseline to 2 months
Secondary	Sleep duration		change from baseline to 2 months