NCT04988542

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

July 26, 2021

Last Update Submit

August 9, 2021

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • Epigenetic Age

    Change from baseline to 2 months

Secondary Outcomes (1)

  • Sleep duration

    change from baseline to 2 months

Study Arms (2)

Sleep supplement

EXPERIMENTAL

Circadian Wellness sleep SL strip nightly for 30 days.

Dietary Supplement: Circadian Wellness sleep SL strip

Control Group

PLACEBO COMPARATOR

Participants in the control group will have no intervention and no change in their usual daily routine or supplements. They will be asked to not take any sleep aid supplement during the study period.

Dietary Supplement: Circadian Wellness sleep SL strip

Interventions

Circadian Wellness sleep SL stripDIETARY_SUPPLEMENT

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.

Control GroupSleep supplement

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women of any ethnicity.
  • Age Range - 16 - 65
  • Patient must be able to comply with treatment plan and laboratory tests

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 22207209BACKGROUND

Study Officials

  • Sanjeev Goel

    Peak Human Labs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjeev Goel, MD

CONTACT

647-966-4385DRGOEL@PEAKHUMAN.CA

Annie Prestrud

CONTACT

annie@trudiagnostic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Patients will be in the control group for 1 month and in the intervention group for one month
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 3, 2021

Study Start

August 30, 2021

Primary Completion

December 1, 2021

Study Completion

April 1, 2022

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share