An Open Label Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in myostatin levels
研究概览
简要总结
This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer > 40 years (adult)
- •Systolic blood pressure 90-140 mmHg upon screening
- •Subject has provided written informed consent
- •Subject is willing to undergo the procedures outlined in this study
- •Subjects BMI is within 18-
- •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.
排除标准
- •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 Musclin™
- •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.
结局指标
主要结局
Change in myostatin levels
时间窗: Day 1(Baseline) to Day 60 (End of Study)
Change in myostatin will be measured by blood samples using ELISA method.
Change in creatinine kinase
时间窗: Day 1(Baseline) to Day 60 (End of Study)
Change in creatinine kinase measured in U/L
Number of Participants with adverse events as a measure of tolerance
时间窗: Day 60 (End of Study)
次要结局
- Changes in weight(Day 1(Baseline) to Day 60 (End of Study))
- Change in cholesterol levels(Day 1(Baseline) to Day 60 (End of Study))
- Number, type, and severity of adverse events(60 days)