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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 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
研究组 & 干预措施
Powder Mix 1
Experimental
Oat powder product, mixed with water
干预措施: Active oat beverage (Other)
Powder Mix 2
Placebo Comparator
Brown rice milk powder product, mixed with water
干预措施: Control rice beverage (Other)
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 (1)
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