Clinical Efficacy of a Supplement on Sleep Quality

TruDiagnostic

Status: Unknown

Conditions: Sleep

Treatments: Dietary Supplement: Circadian Wellness sleep SL strip

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04988542

TD-SQ-001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Sleep supplement

Experimental group

Description:

Circadian Wellness sleep SL strip nightly for 30 days.

Treatment:

Dietary Supplement: Circadian Wellness sleep SL strip

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Circadian Wellness sleep SL strip