Protandim and the Metabolic Syndrome: A Preliminary Study to Define Protein Signatures That Change Along With Lowered Oxidative Stress Measured as F2 Isoprostanes or TBARS and Inflammation Measured as hsCRP
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Measure Decrease in Oxidative Stress markers.
研究概览
简要总结
Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.
详细描述
Evaluate the effects of Protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the Metabolic Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age = 40-60 years of age
- •Meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by NCEP/ATP III criteria)
- •NCEP/ATP III criteria
- •Central obesity as measured by waist circumference:
- •Men - Greater than 40 inches
- •Women - Greater than 35 inches
- •Fasting blood triglycerides greater than or equal to 150 mg/dL
- •Blood HDL cholesterol:
- •Men - Less than 40 mg/dL
- •Women - Less than 50 mg/dL
- •Blood pressure greater than or equal to 130/85 mmHg or on anti-hypertensive Rx
- •Fasting glucose greater than or equal to 100 but < 125 mg/dL
排除标准
- •Women taking hormone replacement therapy for post menopause
- •Signs or symptoms of acute coronary syndrome
- •History of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, EBCT calcium score of at least 100, or a positive stress test)
- •Serum creatinine > 1.5 mg/dL, AST or ALT > 2 times ULN, HgA1c >6.5%, severely depressed or elevated blood cell lines, triglycerides > 500, TSH outside of normal range, elevated calcium, blood pressure > 160/100, urine protein > 30 ,g/dl.
- •Concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes).
- •Participation in any other investigational substance or medical device study within 30 days before this trial and/or participation in such entity during this trial.
- •Known pregnancy.
- •Supplementation with nutraceuticals or if so one month washout before initiating the study before initiating this trial.
- •Taking statins or fibrates to lower cholesterol
- •Inability or unwillingness to provide written informed consent
研究组 & 干预措施
Protandim
one capsule a day for 30 days of protandim given, followed by a wash out period.
干预措施: Protandim (Dietary Supplement)
Placebo
one capsule a day for 30 days will be given followed by a washout period.
干预措施: Protandim (Dietary Supplement)
结局指标
主要结局
Measure Decrease in Oxidative Stress markers.
时间窗: every 30 days for 120 days
the primary purpose of this trial is a preliminary study to examine the relationship to markers of oxidative stress,in response to Protandim, in Metabolic Syndrome.
次要结局
- Protein signatures(every 30 days for 120 days)