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This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Musclin | Experimental | Thymol based dietary supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymol | Dietary Supplement | 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. |
|
| 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) |
| 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 |
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Inclusion Criteria:
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 Musclinâ„¢
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Beach Research Center | Recruiting | West Palm Beach | Florida | 33409 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 6, 2026 | |
| Reset | Jan 21, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 6, 2026 | Jan 21, 2026 |
| ID | Term |
|---|---|
| D013943 | Thymol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Open label, single arm, ascending dose
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|
| Day 1(Baseline) to Day 60 (End of Study) |
| Number, type, and severity of adverse events | 60 days |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D039821 | Monoterpenes |
| D013729 | Terpenes |