Clinical trial NCT03767504: A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
Official title: An Open Label Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Innovus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm, ascending dose
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy volunteer \> 40 years (adult)
2. Systolic blood pressure 90-140 mmHg upon screening
3. Subject has provided written informed consent
4. Subject is willing to undergo the procedures outlined in this study
5. Subjects BMI is within 18-28.
6. 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:

1. Subject has clinically significant deviation from normal in any organ system.
2. Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
3. Pregnant, breastfeeding, or planned pregnancy during the study duration.
4. Known liver, renal or muscle diseases.
5. History of hypertensive or currently taking anti-hypertensive medications.
6. Presence or history of specific heart conditions.
7. Currently taking anti-thyroid or thyroid replacement medications.
8. Currently taking any creatinine kinase lowering drug or supplement.
9. Use of investigational drug within the previous 30 days.
10. Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
11. Known allergies or intolerance to ingredients in Musclin™
12. 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.

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Primary outcomes:
measure: Number of Participants with adverse events as a measure of tolerance
timeFrame: Day 60 (End of Study)
measure: Change in creatinine kinase
timeFrame: Day 1(Baseline) to Day 60 (End of Study)
measure: Change in myostatin levels
timeFrame: Day 1(Baseline) to Day 60 (End of Study)
Secondary outcomes:
measure: Changes in weight
timeFrame: Day 1(Baseline) to Day 60 (End of Study)
measure: Change in cholesterol levels
timeFrame: Day 1(Baseline) to Day 60 (End of Study)
measure: Number, type, and severity of adverse events
timeFrame: 60 days
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
Study officials:
References: