Feasibility Study of Whole Egg Consumption in Adults With Intermediate Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Adherence rate to consuming four whole eggs per day
研究概览
简要总结
Age-related macular degeneration (AMD) is the primary cause of vision loss in people over the age of 55. Currently, no cure is available for individuals suffering from AMD. The purpose of this pilot study is to evaluate the feasibility of implementing a 5-month egg intervention in adults with intermediate AMD. The objective of this research study is to evaluate the feasibility of a whole egg (2 or 4 per day) intervention in older adults with intermediate AMD. The secondary objective of this research is to determine descriptive statistics, change over time and estimate effect sizes for retinal sensitivity, and vision, cognition and physical function. By completing these research objectives, the researchers hope to gain preliminary evidence in support of a larger trial that will assess the impact of egg consumption on eye health in adults with AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with intermediate dry AMD as noted in their medical record (defined as having multiple medium drusen, at least one large druse (>125 μm or the approximate size of a vessel coming off the optic nerve), and/or non-center involving geographic atrophy) who are BCVA stable from prior exam within 6 months - defined by change of < 10 letters on EDTRS chart (BCVA within 10 letters within past 6 months)
- •55 years of age and older
- •Willing to limit consumption of eggs for one month prior to beginning the study intervention
- •Willing to follow diet protocol
- •Body Mass Index (22.0 - 39.9 kg/m2)
- •Access to refrigeration
- •Access to reliable transportation
排除标准
- •Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid and other macular pathology other than AMD
- •Presence of dense cataracts
- •Presence of glaucoma
- •Previous retinal laser or surgical therapy that has impacted the integrity of the retina
- •Any other ocular condition requiring long-term therapy or surgery during the study period
- •Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
- •Diagnosis of nystagmus that will interfere with testing
- •Egg allergy
- •Uncontrolled hyperlipidemia (cholesterol >240 mg/dL in the last 12 months, unless under active medication management to achieve <240 mg/dL)
研究组 & 干预措施
Whole Egg - 2
Participants will be asked to consume 2 medium eggs per day for five months.
干预措施: Whole Egg - 2 (Drug)
Whole Egg - 4
Participants will be asked to consume 4 medium eggs per day for five months.
干预措施: Whole Egg - 4 (Drug)
结局指标
主要结局
Adherence rate to consuming four whole eggs per day
时间窗: From intervention start to the end of treatment at 5 months.
Adherence Rate (%) = (Number of days with 4 whole eggs consumed / Total number of days in the observation period) x 100
次要结局
- Vision function, as measured by percent reduced threshold (PRT)(Baseline and 5 months)
- Vision function, as measured by Average threshold (AT)(Baseline and 5 months)
- Vision function, as measured by Central macular thickness(Baseline and 5 months)
- Vision function, as measured by Best Corrected Visual Acuity (BCVA)(Baseline and 5 months)
- Vision function, as measured by Low Luminance Visual Acuity (LL-BCVA)(Baseline and 5 months)
- Vision function, as measured by Reading Acuity (MN Read)(Baseline and 5 months)
- Vision function, as measured by Contrast Sensitivity(Baseline and 5 months)
- Vision function, as measured by National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)(Baseline and 5 months)
- Cognitive function, as measured by the Hopkins Verbal Learning Test(Baseline and 5 months)
- Physical Function, as measured by balance(Baseline and 5 months)
- Physical Function, as measured by 30-Second Chair Stand(Baseline and 5 months)
- Physical Function, as measured by 30-Second Arm curl(Baseline and 5 months)
- Physical Function, as measured by 8-foot up and go(Baseline and 5 months)
- Quality of Life, as measured by the 36-Item Short Form Health Survey (SF-36)(Baseline and 5 months)
- Dietary Intake(Baseline and 5 months)
- Satisfaction with study participation(From enrollment to the end of treatment at 5 months)
- Satisfaction with egg consumption (Whole Egg - 2)(From intervention start to the end of treatment at 5 months.)
- Satisfaction with egg consumption (Whole Egg - 4)(From intervention start to the end of treatment at 5 months.)
研究者
Kathryn Starr
Associate Professor
Duke University