NCT02729857已完成不适用
Postprandial Response After Intake of Meals With Different Fatty Acid Composition in Patients With Familial Hypercholesterolemia and Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in levels of circulating triglycerides
研究概览
简要总结
The aim of the study is to understand more about how different fatty acids modulate postprandial lipid metabolism and inflammatory response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 30 years of age
- •Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:
- •Treated with low dose statin (<20 mg atorvastatin, <10-20 mg simvastatin or <5-10 mg rosuvastatin)
- •Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)
- •Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)
- •BMI 18.5 - 30 kg/m2
- •Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)
排除标准
- •CRP >10 mg/L
- •TG >4 mmol/L
- •Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism
- •Pregnant or lactating
- •Allergic or intolerant to gluten or egg
- •Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits
- •Using medications affecting lipid metabolism or inflammation, except statins for FH subjects
- •Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))
- •Donating blood 2 months within or during study period
- •Tobacco smoking
- •Large alcohol consumption (>40g daily)
结局指标
主要结局
Change in levels of circulating triglycerides
时间窗: Measured at baseline and 2,4 and 6 hours after intake of test meal
次要结局
- Changes in markers of lipid- and glucose metabolism(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in PBMC Whole genome transcriptomics(Measured at baseline and 4 and 6 hours after intake of test meal)
- Changes in PBMC gene expression levels of markers of inflammation and lipid metabolism(Measured at baseline and 2, 4 and 6 hours after intake of test meal)
- Check DNA for single nuclear polymorphisms(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in circulating levels of inflammatory markers(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in lipid classes and lipoprotein size(Measured at baseline and 2,4 and 6 hours after intake of test meal)
- Changes in plasma and urine metabolomics(Measured in plasma at baseline and 2,4 and 6 hours after intake of test meal. Measured in urine at fasting state and during the 6 hour postprandial phase.)
研究者
Kirsten Holven
Professor
University of Oslo
研究点 (2)
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