NCT01313988已完成不适用
Efficacy Study on the Lipid-lowering Effect of a Spread Enriched With the Recommended Dose of Plant Sterols and 3 Different Doses of Fatty Acids From Fish Oil
Unilever R&D2 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 2
- 主要终点
- Change in blood lipid profile
研究概览
简要总结
Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and women
- •Age ≥ 25 and ≤ 75 years old
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
- •Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
- •10-year CVD risk equal or lower than 10% according to "SCORE"
- •Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
- •Informed consent and biobank consent signed
- •Willing to comply to study protocol during study
- •Agreeing to be informed about medically relevant personal test-results by a physician
- •Not smoking
- •Accessible veins on the forearm
- •Habitually consuming spreads
排除标准
- •Pregnant or having the wish to become pregnant, or lactating
- •Use of prescribed medication which may interfere with study measurements
- •Use of antibiotics in the 3 months before screening or during the study
- •Use of any medically- or self-prescribed diet with the purpose to reduce weight
- •Intolerance for gluten or lactose
- •Reported food allergy
- •Having bleeding disorders
- •Recent blood donation
- •Excessive alcohol consumption
- •Strenuous exercise
- •Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
- •Recent participation in another nutritional or medical trial
- •Participation in night shift work
结局指标
主要结局
Change in blood lipid profile
时间窗: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
次要结局
- Change in EPA/DHA in red blood cells(At baseline (after 4 weeks run-in period) and after 4 weeks intervention)
- Change in metabolomic parameters(At baseline (after 4 weeks run-in period) and after 4 weeks intervention)
研究者
研究点 (2)
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