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临床试验/NCT01480700
NCT01480700已完成不适用

Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People

Institut Pasteur de Lille2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2011年10月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Michel Lecerf

medical doctor specializing in endocrinology and metabolic diseases

Institut Pasteur de Lille

研究点 (2)

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