A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects

Innovus Pharmaceuticals

Status

Unknown

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Thymol

Study type

Interventional

Funder types

Industry

Identifiers

NCT03767504

INNV-MS1000-001

Details and patient eligibility

About

This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.

Full description

This study will be an open label, uncontrolled, ascending dose clinical trial to assess the tolerance and effect of orally ingested Musclin, 20 mg thymol per capsule, in healthy adult subjects. In addition, this study will evaluate whether Musclin has an effect on creatine kinase and myostatin levels. The study will aim to enroll 20 consenting men and women. Consented subjects will ingest 2 capsules of Musclin daily for 30 days and increase to 4 capsules daily for an additional 30 days . Physical assessments and biological samples will be collected at baseline (day 0) and at end of treatment (d 60). Surveys to include reported stamina and energy levels will be collected at baseline, prior to increased dosage (d 30) and end of treatment period. Risk to participants is expected to be minimal and will be outlined through an informed consent.

Enrollment

20 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteer > 40 years (adult)
Systolic blood pressure 90-140 mmHg upon screening
Subject has provided written informed consent
Subject is willing to undergo the procedures outlined in this study
Subjects BMI is within 18-28.
Subjects of childbearing potential must use a hormonal method of birth control, single-barrier method or a double-barrier method of birth control throughout the study or be documented as medically sterile.

Exclusion criteria

Subject has clinically significant deviation from normal in any organ system.
Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
Pregnant, breastfeeding, or planned pregnancy during the study duration.
Known liver, renal or muscle diseases.
History of hypertensive or currently taking anti-hypertensive medications.
Presence or history of specific heart conditions.
Currently taking anti-thyroid or thyroid replacement medications.
Currently taking any creatinine kinase lowering drug or supplement.
Use of investigational drug within the previous 30 days.
Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
Known allergies or intolerance to ingredients in Musclin™
Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.