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Central Retinal Enrichment Supplementation Trials (CREST): Design and Methodology of the CREST Randomized Controlled Trials

Creator:

Akuffo KO, Beatty S, Stack J, Dennison J, O'Regan S, Meagher KA, Peto T, Nolan JM

Subject Keywords: Nutrition, Ageing, Older People, Mental Health, Alzheimer's Disease
Catalogue: Systematic Reviews
Type: Report
Region: Republic of Ireland
Description:

Purpose: The Central Retinal Enrichment Supplementation Trials (CREST) aim to investigate the potentialimpact of macular pigment (MP) enrichment, following supplementation with a formulation containing 10 mglutein (L), 2 mg zeaxanthin (Z) and 10 mgmeso-zeaxanthin (MZ), on visual function in normal subjects (Trial 1)and in subjects with early age-related macular degeneration (AMD; Trial 2).Methods: CREST is a single center, double-blind, randomized clinical trial. Trial 1 (12-month follow-up) subjectsare randomly assigned to a formulation containing 10 mg L, 10 mg MZ and 2 mg Z (n= 60) or placebo (n= 60).Trial 2 (24-month follow-up) subjects are randomly assigned to a formulation containing 10 mg L, 10 mg MZ,2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention A;n= 75) or 10 mg Land 2 mg Z plus 500 mg vitamin C, 400 IU vitamin E, 25 mg zinc and 2 mg copper (Intervention B;n= 75).Contrast sensitivity (CS) at 6 cycles per degree represents the primary outcome measure in each trial. Secondaryoutcomes include: CS at other spatial frequencies, MP, best-corrected visual acuity, glare disability, photostressrecovery, light scatter, cognitive function, foveal architecture, serum carotenoid concentrations, and subjectivevisual function. For Trial 2, AMD morphology, reading speed and reading acuity are also being recorded.Conclusions: CREST is the first study to investigate the impact of supplementation with all three macularcarotenoids in the context of a large, double-blind, randomized clinical trial.

Date:

15/10/2014

Rights: © Public
Suggested citation:

Akuffo KO, Beatty S, Stack J, Dennison J, O'Regan S, Meagher KA, Peto T, Nolan JM. (2014) Central Retinal Enrichment Supplementation Trials (CREST): Design and Methodology of the CREST Randomized Controlled Trials [Online]. Available from: http://publichealthwell.ie/node/1264325 [Accessed: 17th November 2019].

  

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Contributor:

Nutritional Research Centre Ireland (NRCI)
 
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