NCT02376660已完成不适用
A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- reduction of total cholesterol
研究概览
简要总结
A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In total 3 assessment visits of the subjects planned for the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 20 and 50 years old
- •Total Cholesterol: ≥ 200 mg/dL and < 240mg/dL
- •Availability and willingness to follow study protocol
- •Stable body weight for previous 3 months (not more than 5% weight change)
排除标准
- •Subjects already on lipid lowering drugs
- •LDL-c > 190 mg/dL
- •Total cholesterol <200 mg/dL and >240 mg/dL
- •Subjects with serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
- •Baseline Triglycerides: > 300 mg/dL
- •Diabetes (Type 1 or Type 2) as diagnosed by a physician
- •Uncontrolled hyperthyroidism (as per physician's discretion)
- •Uncontrolled hypertension (as per physician's discretion)
- •Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history
- •Irritable bowel syndrome by history
- •Unwillingness to give written informed consent for participation in the study.
- •Pregnancy & lactation (by history)
- •Severe end organ damage
- •Subjects with allergy to oats
- •Heavy smokers (smoking more than 5 cigarettes per day)
结局指标
主要结局
reduction of total cholesterol
时间窗: 4 weeks
次要结局
- Blood pressure(4 weeks)
- LDL-c(4 weeks)
- Triglycerides(4 weeks)
研究者
相似试验
已完成
不适用
Oat and CholesterolElevated LDL CholesterolNCT03911427PepsiCo Global R&D207
招募中
不适用
Effect of Bergamot Juice on LDL Cholesterol Level in Healthy SubjectsHealthyNCT05589636Azienda Ospedaliero-Universitaria di Parma44
已完成
不适用
Randomized control trial of effect of cholesterol absorption with ischemic heart disease patients.Ischemic heart disease.JPRN-UMIN000002297Kameda General Hospital, department of cardiology.250
已完成
不适用
Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy ProductHypercholesterolemiaNCT05064644Raisio Group55
已完成
不适用
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)HypercholesterolemiaNCT01600820Danone Spain126