Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change From Baseline in Lipid Profile
研究概览
简要总结
The hypothesis of this study is that the natural supplement Capros will decrease LDL levels, platelet aggregation, and serum concentrations of high sensitivity C-reactive protein in humans at risk for cardiovascular disease.
详细描述
A non-randomized, longitudinal study to determine the effect of Capros supplementation on a lipid profile, platelet aggregation and high-sensitivity C - reactive protein in 30 volunteers at risk for cardiovascular disease.
-Herbal Polyphenols/Antioxidants: Role in Cardiovascular Disease Prevention: Phenolic compounds are dietary antioxidants found in plants that are shown to inhibit LDL oxidation, inhibit platelet aggregation and adhesion, decrease total and LDL cholesterol, and induce endothelium-dependent vaso-relaxation. [Lapointe, Vita, and Mendes]. Epidemiologic studies suggest that higher polyphenol intake from fruits and vegetables is associated with decreased risk for cardiovascular disease. Among the numerous plausible mechanisms by which polyphenols may offer cardiovascular protection, improvement of the endothelial function and inhibition of angiogenesis and cell migration and proliferation in blood vessels have been the focuses of recent studies. Antioxidants in polyphenols, in addition to protecting LDL cholesterol against oxidation, may act at a vascular cell level by limiting cellular production of reactive oxygen species, and, thus, cell-mediated LDL oxidation. In traditional Indian medicine, the gooseberry (Phyllanthus emblica) has been used for thousands of years as an effective source of polyphenols and antioxidants. "P. emblica is considered beneficial against various diseases namely cancer, diabetes, liver treatment, and various other diseases."[Hiraganahalli]. Capros®, from Natreon, Inc., is a cascading antioxidant ingredient derived from Phyllanthus emblica. It has been used in cosmetics and food-and-beverage formulations in many countries, and, based on extensive scientific research, also shows particular promise as a dietary supplement.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 21-70 years of age
- •BMI 25-35
排除标准
- •BMI > 35 OR < 25
- •Individuals who are deemed unable to understand the procedures, risks and benefits of the study, i.e. Informed consent will be excluded
- •Females who are pregnant as well as individuals who are therapeutically immuno-compromised will also be excluded in order to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.
- •Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable. Pregnant women are excluded to minimize the risk to such individuals (and fetus) and to decrease statistical variability and to minimize potential of confounders.
研究组 & 干预措施
Capros dietary supplement
Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.
干预措施: Capros dietary supplement (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Lipid Profile
时间窗: Baseline and 14 weeks
Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period
次要结局
- C-reactive Protein(Baseline and 14 weeks)
- Changes From Baseline in Platelet Aggregometry(Baseline and 14 weeks)
- Changes in High-Sensitivity C-reactive Protein(Baseline and 14 weeks)
研究者
Chandan K Sen
Professor
Ohio State University