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临床试验/NCT04496817
NCT04496817招募中不适用

Effects of DHA and Lutein Enriched Eggs on Retina Health and Metabolic and Physical Parameters in Type 2 Diabetes: a Strategy for Diabetic Retinopathy

University of Manitoba2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Change in Retina Function

研究概览

简要总结

Diabetes mellitus has been declared a major public health issue. Among the complications of the disease, retinopathy can have a significant impact on mobility and quality of life for individuals living with diabetes. As the leading cause of new blindness in adults, diabetic retinopathy has been shown to affect 23% of all Type 1 and 14% of Type 2 diabetic individuals. Various studies have reported that a number of components in the egg may contribute to visual function and eye health. Specifically, i) egg yolk naturally contains, and can be further enriched with the carotenoids lutein and zeaxanthin. Lutein and zeaxanthin protect the retina against light induced retinal damage by acting as potent antioxidants that shield the retina from harmful short-wave radiation. ii) eggs can also be enriched to provide a vehicle for specific nutrients to promote eye health including omega-3 fatty acid, docosahexaenoic acid (DHA). A substantial amount of DHA is uniquely found within the retina. A DHA deficiency has shown to induce abnormal retina function indicating a constant supply of this nutrient is necessary for retina health. Currently, the American Diabetes Association declares that eggs are an excellent choice for people with diabetes, but information lacks on the status of whole egg consumption in diabetic individuals in relation to their retinal health. Therefore, the current study aims to determine if the consumption of two lutein and DHA enriched eggs per day can safely improve the retina function of individuals with type 2 diabetes.

A total of 60 adult diabetic male and female participants will be recruited to take part in this double-blinded, randomized, placebo-controlled, parallel trial. Participants will be randomly assigned to include two DHA and lutein enriched eggs or regular eggs into their usual diet for 6 weeks. At the beginning and end of the trial, a variety of measures will be analyzed including blood lipid parameters, carotenoid status, anthropometrics, arterial stiffness, advanced glycated end products, macular pigment optical density and electroretinography. These measures will aid in determining whether enriched egg consumption can safely improve retina function, while not adversely effecting body composition and cardiovascular risk factors in individuals with diabetes. The results of this study will contribute to the development of valuable prevention strategies for eye health in individuals with diabetes, thereby improving their quality of life.

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
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (>19 years of age)
  • Individuals diagnosed with Type 2 diabetes
  • Individuals taking oral hypoglycemic medications (sulfonylureas, meglitinides, biguanides, thiazolidinediones etc.)
  • Individuals with a fasting plasma glucose of ≥7.0 mmol/L or glycated hemoglobin (A1C) of ≥6.5%. (these values are based on the Canadian Diabetes Association and are predictors of the development of diabetic retinopathy)

排除标准

  • Individuals previously diagnosed with moderate to severe diabetic retinopathy (to assess egg consumption as a preventative strategy for diabetic retinopathy).
  • Individuals with eye disease (cataracts, glaucoma, age-related macular degeneration, retinitis pigmentosa, optic atrophy, and eye malformation etc.)
  • Individuals with Alzheimer's, dementia or other mental cognitive diseases
  • Individuals with Type 1 diabetes
  • Individuals taking insulin
  • Individuals diagnosed with cancer or anemia
  • Pregnant women

结局指标

主要结局

Change in Retina Function

时间窗: 6 weeks

Measured by Full Field Electroretinography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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