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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Thymol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Recruiting
      • Palm Beach Research Center
      • Contact: Regina Waters, MA; Phone Number: 561-689-0606; Email: regina@palmbeachresearch.com
      • Principal Investigator: Mira Baron, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Musclin; Thymol based dietary supplement	Dietary supplement: Thymol; Musclin - a dietary supplement: 2 capsules (20 mg thymol per capsule) BID with a meal for 30 days increased to 4 capsules for an additional 30 days.; Other Names: Musclin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with adverse events as a measure of tolerance		Day 60 (End of Study)
Change in creatinine kinase	Change in creatinine kinase measured in U/L	Day 1(Baseline) to Day 60 (End of Study)
Change in myostatin levels	Change in myostatin will be measured by blood samples using ELISA method.	Day 1(Baseline) to Day 60 (End of Study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	Effect of supplement on weight (lbs)	Day 1(Baseline) to Day 60 (End of Study)
Change in cholesterol levels	Effect of supplement on cholesterol levels	Day 1(Baseline) to Day 60 (End of Study)
Number, type, and severity of adverse events		60 days

Collaborators and Investigators

• Sponsor: Innovus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Anticipated): February 13, 2019
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Antifungal Agents; Thymol
• Other Study ID Numbers: INNV-MS1000-001

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