The Effect of an Integrative Dietary Supplement on the Lipid Profile of Subjects With Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- LDL cholesterol
研究概览
简要总结
This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100 subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks and 12 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LDL-C 110 - 190 mg/dL
- •For current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose.
- •Age 18 - 85 years
排除标准
- •Type 1 diabetes
- •Severe hypertension, defined as at least 180 / 100 mmHg
- •Any other health condition that may interfere with the study results, as judged by the principle investigator
- •Allergy against any of the ingredients in the tested product
- •Any medical condition, in which fiber consumption is contraindicated (e.g. Crohn's disease
- •The use of nutritional supplements during the last two months containing one or more similar ingredients, as the tested supplement.
- •History of alcohol or drug abuse, psychological or other mental issues that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
- •Participation in any other studies involving investigational or marketed product concomitantly or within one month prior to entry into the study
- •Pregnant or breast feeding
- •Persons who eat only 1 meal per day
研究组 & 干预措施
I
Cohort I subjects will take supplement for 12 weeks
干预措施: BiosLife Complete (Dietary Supplement)
II
Cohort II will take placebo for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
LDL cholesterol
时间窗: 12 weeks
HDL cholesterol
时间窗: 12 weeks
次要结局
- triglycerides(12 weeks)
- LDL particle number(12 weeks)
- LDL particle size distribution(12 weeks)
- HDL particle number(12 weeks)
- HDL particle size distribution(12 weeks)
- VLDL particle number(12 weeks)