Intervention With n3 LC-PUFA-supplemented Yogurt: Effects on Cardiovascular Risk Factors and Inflammatory Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
研究概览
简要总结
The effective dosage of a n3-LC-PUFA intervention (with n3 LC-PUFA-enriched yoghurt) on the modulation of cardiovascular risk factors and inflammatory biomarkers were determined.
详细描述
Fifty three mildly hypertriacylglycerolemic subjects (TAG ≥ 150 mg/dL (1.7 mmol/L)) participated on the placebo-controlled, double-blind, parallel designed study.
The subjects consumed placebo yoghurt (1), or n3 LC-PUFA-enriched yoghurt (0.8 g n3 LC-PUFA/d (2), 3 g n3 LC-PUFA/d (3)) for 10 weeks.
Blood samples were taken at the beginning and at the end of the period.
Parameters:
- Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
- Fatty acid distribution of plasma lipids (PL) and erythrocyte membranes (EM)
- Concentrations of eicosanoids (PGs, HETEs)
- Production of ex vivo stimulated cytokines by T cells
- SNPs in the CD36 genotype
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
- 否
入选标准
- •hypertriacylglycerolemic subjects (TAG: ≥ 150 mg/dl (1.7 mmol/l))
排除标准
- •patients receiving blood-diluting and lipid-lowering medications or glucocorticoids
- •patients suffering from gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyper- and hypothyroidism) and hypercholesteremic patients with familial previous impacts
- •patients taking dietary supplements (e.g., fish oil capsules, vitamin E) or having either known allergies or foodstuff indigestibility
- •further exclusion criteria: smoking, high sportive activity or daily alcohol intake
结局指标
主要结局
Blood lipids (total cholesterol, HDL, LDL, triacylglycerols)
时间窗: change from baseline after 10 weeks
change from baseline after 10 weeks Group 1: placebo Group 2: 0.8 g n3 LC-PUFA/125 g yoghurt per day Group 3: 3 g n3 LC-PUFA/200 g yoghurt per day
次要结局
- fatty acid distribution in plasma lipids and erythrocyte membranes, eicosanoids in plasma, production of ex vivo stimulated cytokines by T cells, SNPs on CD36 genotype(change from baseline after 10 weeks)
研究者
Gerhard Jahreis
Proffessor Dr. G. Jahreis
University of Jena