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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767504
• Other study ID #: INNV-MS1000-001
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2018
• Source: Innovus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Innovus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with adverse events as a measure of tolerance		Day 60 (End of Study)
Primary	Change in creatinine kinase	Change in creatinine kinase measured in U/L	Day 1(Baseline) to Day 60 (End of Study)
Primary	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	Changes in weight	Effect of supplement on weight (lbs)	Day 1(Baseline) to Day 60 (End of Study)
Secondary	Change in cholesterol levels	Effect of supplement on cholesterol levels	Day 1(Baseline) to Day 60 (End of Study)
Secondary	Number, type, and severity of adverse events		60 days