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. 2024 Oct 18;11:1422468. doi: 10.3389/fnut.2024.1422468

Table 2.

Schedule for enrollment, interventions, and assessments.

Time point Study period
Enrollment Allocation Post-allocation
-t1 t1 t2 t3
(Week 0) (Week 12) (Week 24)
Enrollment
Eligibility screen ×
Informed consent ×
Allocation ×
Interventions
Tablet 1 and placebo 1 graphic file with name fnut-11-1422468-i001.jpg
Tablet 2 and placebo 1 graphic file with name fnut-11-1422468-i001.jpg
Tablet 3 and placebo 1 graphic file with name fnut-11-1422468-i001.jpg
Tablet 4 and placebo 1 graphic file with name fnut-11-1422468-i001.jpg
Tablet 4 and capsule 1 graphic file with name fnut-11-1422468-i001.jpg
Placebo 1 and placebo 2 graphic file with name fnut-11-1422468-i001.jpg
Assessments
Demographics ×
Lifestyle behaviors × × ×
Medical history and medications × × ×
Dietary assessment × × ×
Anthropometry × × ×
MPOD × × ×
UCVA and BCVA × × ×
CS and GS × × ×
CFF × × ×
Reaction time × × ×
Visuognosis persistence × × ×
Symptoms and signs of DED × ×
Retinal thickness × ×
Optical quality × ×
DNA extraction and genotyping ×
Fasting blood (e.g., serum lutein and zeaxanthin, RBC membrane omega-3 fatty acids) × × ×
Stool samples for microbiome analysis × ×
Provided supply of supplements × ×
Adverse events × × ×
Collect unused test product × ×

t1, baseline; t2, at 12 weeks; t3, at 24 weeks; MPOD, macular pigment optical density; UCVA, uncorrected visual acuity; BCVA, best-corrected visual acuity; CS, contrast sensitivity; GS, glare sensitivity; CFF, critical flicker fusion; DED, dry eye disease; RBC, red blood cell.