NCT03911427已完成不适用
Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Change in fasting serum LDL-cholesterol
研究概览
简要总结
The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo.
Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L)
- •Males and non-pregnant, non-lactating females 18-65 years
- •Agree to consume the investigational product three times daily for the duration of the study
- •BMI 18.5 to 39.9 kg/m2
- •Blood pressure <160/100 mmHg
- •Fasting triglycerides <4.0 mmol/L
- •Fasting serum glucose <126mg/dL (<7 mmol/L)
- •Serum urea and creatinine < 1.8 times upper limit of normal (ULN)
- •Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) < 2 times ULN
- •Hemoglobin > 0.9 times lower limit of normal and < 1.1 times ULN
- •Have a stable body weight (<7 kg change) over the past 3-months
- •Absence of health conditions that would prevent fulfillment of study requirements
排除标准
- •Pregnancy, breastfeeding or planning to be pregnant
- •Allergy or sensitivity to study product ingredients
- •Dislike description of study product
- •Diet containing ≥15% of energy from saturated fat
- •Consuming >20g fiber/per 1000 Kcal or >40g fiber/day (including soluble fiber supplements)
- •Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week
- •Extreme dietary habits
- •Smoking >5 cigarettes or equivalent per day
- •Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization
- •Active major gastrointestinal disorder
- •Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization
- •History of cancer within two years or randomization, except for non-melanoma skin cancer
- •Any condition or substance use which might, in the opinion of the PI, make participation dangerous for the participant, lead to poor attendance or compliance or affect the results
结局指标
主要结局
Change in fasting serum LDL-cholesterol
时间窗: Baseline vs. Week 4
Reduction in mmol/L is a better outcome and \>=5% reduction would be significant
次要结局
- Change in fasting serum HDL cholesterol(Baseline vs. Week 4)
- Change in fasting non-HDL-cholesterol(Baseline vs. Week 4)
- Change in fasting triglycerides(Baseline vs. Week 4)
- Change in fasting glucose(Baseline vs. Week 4)
- Change in fasting insulin(Baseline vs. Week 4)
- Change in fasting glycated albumin(Baseline vs. Week 4)
- Change in fasting HOMA-IR(Baseline vs. Week 4)
- Change in Framingham risk score(Baseline vs. Week 4)
- Change in fasting serum total cholesterol(Baseline vs. Week 4)
研究者
研究点 (2)
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