Clinical Efficacy of a Supplement on Sleep Quality

August 9, 2021 updated by: TruDiagnostic

Clinical Efficacy of a Novel Delivery Supplement on Sleep Quality

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sleep supplement
Circadian Wellness sleep SL strip nightly for 30 days.
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.
PLACEBO_COMPARATOR: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epigenetic Age
Time Frame: Change from baseline to 2 months
Change from baseline to 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep duration
Time Frame: change from baseline to 2 months
change from baseline to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TruDiagnostic

Collaborators

Circadian Wellness Corp

Investigators

  • Principal Investigator: Sanjeev Goel, Peak Human Labs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 30, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (ACTUAL)

August 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TD-SQ-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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