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

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ClinicalTrials.gov Identifier: NCT03767504
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Innovus Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Thymol Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, single arm, ascending dose
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : February 13, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Thymol

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 Name: Musclin




Primary Outcome Measures :
  1. Number of Participants with adverse events as a measure of tolerance [ Time Frame: Day 60 (End of Study) ]
  2. Change in creatinine kinase [ Time Frame: Day 1(Baseline) to Day 60 (End of Study) ]
    Change in creatinine kinase measured in U/L

  3. Change in myostatin levels [ Time Frame: Day 1(Baseline) to Day 60 (End of Study) ]
    Change in myostatin will be measured by blood samples using ELISA method.


Secondary Outcome Measures :
  1. Changes in weight [ Time Frame: Day 1(Baseline) to Day 60 (End of Study) ]
    Effect of supplement on weight (lbs)

  2. Change in cholesterol levels [ Time Frame: Day 1(Baseline) to Day 60 (End of Study) ]
    Effect of supplement on cholesterol levels

  3. Number, type, and severity of adverse events [ Time Frame: 60 days ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767504


Locations
United States, Florida
Palm Beach Research Center Recruiting
West Palm Beach, Florida, United States, 33409
Contact: Regina Waters, MA    561-689-0606    regina@palmbeachresearch.com   
Principal Investigator: Mira Baron, MD         
Sponsors and Collaborators
Innovus Pharmaceuticals, Inc.

Responsible Party: Innovus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03767504     History of Changes
Other Study ID Numbers: INNV-MS1000-001
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thymol
Anti-Infective Agents
Anti-Infective Agents, Local
Antifungal Agents