The Effects of ProAlgaZyme Novel Algae Infusion vs. Placebo on Metabolic Syndrome and Markers of Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- hsCRP
研究概览
简要总结
The purpose of this study is to compare the effects of supplementation with ProAlgaZyme (a novel fermentation product of a freshwater algae ecosystem) vs. placebo on Metabolic Syndrome and indicators of cardiovascular health including: body weight and fat, blood lipids, inflammatory markers such as hsCRP, blood pressure and fasting blood glucose.
详细描述
Metabolic syndrome, a set of symptoms strongly associated with increased risk for both cardiovascular disease and diabetes, is generally linked to obesity and has become a serious problem in many industrialized countries. Agents that aid in weight loss or help to normalize blood lipids or inflammation may reduce the risk of metabolic syndrome and therefore, reduce the risk of cardiovascular disease and diabetes. This study is a single-center, double-blind, placebo-controlled, parallel design, to evaluate the effects of ProAlgaZyme (4 fl. oz. daily) on metabolic syndrome and markers of cardiovascular health including blood lipids, inflammatory markers and anthropometric measurements.
Comparisons: ProAlgaZyme vs. placebo [Time frame: 10 weeks]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet 3 of the following criteria:
- •BMI ≥30 kg/m2
- •HDL Cholesterol of <40
- •Triglycerides >150 mg/dl
- •Fasting blood glucose >100 mg/dl
- •Blood pressure >130/85 mm Hg
- •Total Cholesterol of >200 mg/dl
- •LDL Cholesterol of >160 mg/dl
- •Interleukin 6 (IL-6) >5pg/mL
排除标准
- •Morbidly obese: BMI >40 kg/m2
- •Taking any cholesterol-lowering medications 30 days prior to the start of enrollment and during the course of the study.
- •Enrolled in another clinical study in the past 6 months.
- •Pregnant, actively infected, on medication that interfered with healing (for example, steroids), were inflicted with systemic disease such as AIDS, HIV, active hepatitis or active malignancy (clinical signs within the past 5 years), or suffered from diabetes mellitus requiring daily insulin management.
结局指标
主要结局
hsCRP
时间窗: 10 weeks
Lipids (total cholesterol, triglycerides HDL-C, LDL-C)
时间窗: 10 weeks
Anthropometric measurements (weight/BMI, % body fat, blood pressure)
时间窗: 10 weeks
Fasting Blood Glucose
时间窗: 10 weeks
次要结局
- Insulin(10 weeks)
- Interleukin-6 (IL-6)(10 weeks)
- TNF-alpha(10 weeks)
- RBC Sedimentation Rate(10 weeks)