A Double-blinded, Placebo-controlled Randomized Trial Assessing the Extent to Which Consumption of Two Different Amounts of a Non-Pharmaceutical Food Supplement Can Improve Cardiovascular Health
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline in Total Cholesterol and LDL levels at 30 days
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a food-source nutrient containing bitter orange by comparing changes 45 blood chemistries and self-reported quality of life.
详细描述
To evaluate the safety and efficacy of a food-source nutrient by comparing changes in total cholesterol levels, 44 other blood chemistries, and self-reported quality of life as a function of consuming two different functional-food supplements versus a placebo in a 60-day study.
Upon completion of the pre-study screening, and after having received an explanation of the requirements, risks and benefits, and completing the informed consent interview with the research coordinator, subjects will execute a written informed consent. Subjects will be randomly assigned to one of three study groups.
Relevant Background Information.
A factor leading to development of vascular disease, a leading cause of death in industrialized nations, is elevated serum cholesterol. It is estimated that 19% of Americans between the ages of 20 and 74 years of age have high serum cholesterol. However, in an analysis of 10,000 test results in our database from subjects similar to those who are likely to participate in this study, we found 37% of subjects had TC scores between 200 and 250 and 10.3% above 250.
The most prevalent form of vascular disease is arteriosclerosis, a condition associated with the thickening and hardening of the arterial wall. The regulation of whole-body cholesterol homeostasis involves the regulation of intestinal cholesterol absorption, cellular cholesterol trafficking, a modulation of cholesterol biosynthesis, bile acid biosynthesis, steroid biosynthesis and the catabolism of the cholesterol-containing plasma lipoproteins. Regulation of intestinal cholesterol absorption has proven to be an effective means by which to regulate serum cholesterol levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be an English-speaking male or female at least 18 years of age;
- •have a total cholesterol level between 200 mg/dL and 250mg/dL
- •have a LDL level between 100 mg/dL and 160 mg/dL
- •not have allergic reactions to eggs or egg products
- •not have consumed cholesterol-lowering drugs within 2 months of starting the study
- •agree to follow the requirements of the study as set forth in this Informed Consent
- •agree to withdraw from the study if becoming pregnant during the study.
排除标准
- •do not speak English;
- •are under 18 years of age;
- •have a total cholesterol level below 200 mg/dL or above 250 mg/dL
- •have a LDL level below 100 mg/dL or above 160 mg/dL
- •have allergic reactions to eggs or egg products
- •have consumed cholesterol-lowering drugs within 2 months of starting the study
- •are pregnant or nursing;
结局指标
主要结局
Change from baseline in Total Cholesterol and LDL levels at 30 days
时间窗: 0 and 30 days
Change from baseline in Total Cholesterol and LDL levels at 60 days
时间窗: 0 and 60 days
Change from mid-point in Total Cholesterol and LDL levels at 60 days
时间窗: 30 and 60 days
次要结局
- Blood Chemistry Measurements(0, 30, and 60 days)
- Self-reported Quality of Life(0, 30, and 60 days)
- Number of participants with adverse effects(up to 60 days)
研究者
Gilbert R Kaats
Dr. Gilbert R. Kaats, PhD
Integrative Health Technologies, Inc.