Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- change from baseline in optical density of macular pigment after 4 months of eggs consumption
研究概览
简要总结
This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular Degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects (male or female),
- •18 to 55 years
- •Having signed the consent form,
- •Susceptible to accept the stresses generated by the study,
排除标准
- •Corrected Visual Acuity <8/10th,
- •History of cardiovascular disease, specifically coronary heart disease,
- •Characterized dyslipidemia
- •* Total cholesterol ³ 2.50 g / L, and / or triglycerides ³ 2.00 g / L
- •Lipid-lowering treatment,
- •Current smoking or person who stopped smoking less than 6 months
- •Cataract or cataract surgery,
- •Body Mass Index (BMI)> 30 kg/m2,
- •Taking food supplements in the 3 months preceding the start of the study (carotenoids, omega-3 fatty acids, phytosterols),
- •Regular consumption in the three months preceding the start of the study products with added phytosterols.
- •Regular consumption of high fatty fish or shellfish rich in omega-3 (4x a week or more): salmon, sardines, mackerel, herring, trout, tuna, red mullet, sea bass, bream, farmed turbot, mussels, squid / squid, anchovies.
- •Allergy to eggs
- •Difference significant weight over the last 3 months (> 3 kg)
- •Inability to understand or adhere to the protocol
- •Persons deprived of liberty
- •People in a position to judicial protection
- •Pregnant Women.
结局指标
主要结局
change from baseline in optical density of macular pigment after 4 months of eggs consumption
时间窗: before the eggs consumption and four months afterwards
optical density of macular pigment was measured with a Heidelberg Retinal Angiograph (HRA)specially modify for the measure of the pigment.
次要结局
- change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption(before the eggs consumption and four months afterwards)
- change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption(before the eggs consumption and four months afterwards)
研究者
Jean-Michel Lecerf
medical doctor specializing in endocrinology and metabolic diseases
Institut Pasteur de Lille
