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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Egg - 4 | Experimental | Participants will be asked to consume 4 medium eggs per day for five months. |
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| Whole Egg - 2 | Active Comparator | Participants will be asked to consume 2 medium eggs per day for five months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Egg - 4 | Drug | Participants will be asked to consume 4 medium Eggland's Best eggs per day for 5 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate to consuming four whole eggs per day | Adherence Rate (%) = (Number of days with 4 whole eggs consumed / Total number of days in the observation period) x 100 | From intervention start to the end of treatment at 5 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Vision function, as measured by percent reduced threshold (PRT) | Mesopic microperimetry with eye tracking (MAIA) results will be reported as percent reduced threshold (PRT), defined as the percentage of abnormal retinal sensitivity thresholds below 25 dB. | Baseline and 5 months |
| Vision function, as measured by Average threshold (AT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn N Starr, PhD, RDN | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Living | Durham | North Carolina | 27705 | United States |
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| Whole Egg - 2 | Drug | Participants will be asked to consume 2 medium Eggland's Best eggs per day for 5 months. |
|
Mesopic microperimetry with eye tracking (MAIA) results will be reported as average threshold (AT), defined as the average of retinal sensitivity values from all loci tested. |
| Baseline and 5 months |
| Vision function, as measured by Central macular thickness | Central macular thickness will be measured by Optical Coherence Tomography (OCT) | Baseline and 5 months |
| Vision function, as measured by Best Corrected Visual Acuity (BCVA) | BCVA will be assessed by reading a standard eye chart placed at a distance | Baseline and 5 months |
| Vision function, as measured by Low Luminance Visual Acuity (LL-BCVA) | LL-BCVA will be assessed by reading a standard eye chart placed at a distance in low-light conditions | Baseline and 5 months |
| Vision function, as measured by Reading Acuity (MN Read) | Participants will be asked to read a chart with various print sizes (MNREAD acuity charts) | Baseline and 5 months |
| Vision function, as measured by Contrast Sensitivity | Participants will be asked to read letters (which will be colored in a range of gray) on an eye chart or iPad, placed at a distance. | Baseline and 5 months |
| Vision function, as measured by National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) | Participants will rate their vision on multiple activities of daily living based on their own opinion. The NEI VFQ-25 is scored by converting item responses to a 0-100 scale, averaging them into subscales, and calculating a composite score (excluding general health), with higher scores indicating better visual function. | Baseline and 5 months |
| Cognitive function, as measured by the Hopkins Verbal Learning Test | The Hopkins Verbal Learning Test is scored by summing the number of correct words recalled across three learning trials (Total Recall), the number recalled after a delay (Delayed Recall), and the number of correctly identified words on a recognition task (Recognition Discrimination Index), with higher scores indicating better verbal learning and memory performance. | Baseline and 5 months |
| Physical Function, as measured by balance | Will be asked to stand for 10 seconds with feet in 3 different positions (side-by-side, semi-tandem, tandem). The balance component of the SPPB is scored from 0 to 4 based on the ability to hold side-by-side, semi-tandem, and tandem stances for up to 10 seconds each, with higher scores indicating better balance. | Baseline and 5 months |
| Physical Function, as measured by 30-Second Chair Stand | Number of full stands that can be completed in 30 seconds with arms folded across chest | Baseline and 5 months |
| Physical Function, as measured by 30-Second Arm curl | Number of arm curls completed in 30 seconds. | Baseline and 5 months |
| Physical Function, as measured by 8-foot up and go | Number of seconds required to get up from a seated position, walk 8 feet (2.44 m), turn, and return to seated position | 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 | 3-day food record and recalls. Total calories (kcals) consumed are determined by averaging the intake of three days. A higher mean number indicates that more calories are consumed. | Baseline and 5 months |
| Satisfaction with study participation | On a 1-5 Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied), overall, how satisfied are you with your decision to participate in this study? | From enrollment to the end of treatment at 5 months |
| Satisfaction with egg consumption (Whole Egg - 2) | On a 1-5 Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied), How satisfied were you with consuming two medium eggs per day for the duration of the study? | From intervention start to the end of treatment at 5 months. |
| Satisfaction with egg consumption (Whole Egg - 4) | On a 1-5 Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied), how satisfied were you with consuming four medium eggs per day for the duration of the study? | From intervention start to the end of treatment at 5 months. |