Carotenoid Supplementation and Normal Ocular Health

Phase 2

Completed

• Conditions: Retinal Ageing
• Interventions: Dietary Supplement: VisionAce; Dietary Supplement: Placebo

• Registration Number: NCT02147171
• Lead Sponsor: University of Manchester

Brief Summary

Normal ageing affects vision as a result of preretinal and retinal changes. Photoreceptors, the light sensitive cells in the retina, degenerate and the rods (responsible for night vision) are most susceptible to damage with increasing age. Rod loss leads to poor vision in the dark which increases the risk of accidents amongst the elderly. Macular pigment (located in the photoreceptors)is thought to protect the retina and reduce the risk of age related changes. Dark adaptation, mediated by the rods, slows down with age, and is also reduced in AMD (age-related macular degeneration). Recent evidence suggests that lutein (the main component of macular pigment) supplementation improves the dark adaptation deficit in AMD subjects. Research into the effects of lutein in a normal human has not been previously conducted. Since the older population is increasing, our aim is to firstly establish the extent of night vision loss (using dark adaptometry) and secondly to examine the possibility of slowing down or reversing this loss through lutein supplementation.

Detailed Description

It is believed that the macular pigment protects the retina against photooxidative damage which can lead to agerelated macular degeneration (AMD). It is also hypothesized to enhance visual performance in normal human eyes. Much of the research into lutein supplementation has been centered around AMD subjects. AMD can result from agerelated retinal photoreceptor dysfunction which could hypothetically be prevented or slowed down through early supplementation. To our knowledge, the effects of lutein in normal ageing, have not been studied previously.

Macular pigment is composed of lutein and zeaxanthin. These compounds absorb blue light and therefore protect the retinal photoreceptors. They also possess powerful antioxidant properties and therefore help maintain the integrity of the macular region. With increasing age, the visual performance worsens as a result of preretinal and retinal changes such as photoreceptor degeneration. Rods (responsible for night vision) are highly susceptible to degeneration in a normal aging eye and in AMD. Older subjects often complain of reduced vision in the dark which can contribute to increased risk of road traffic accidents and falls. Since the older population is rapidly growing, it is vital to study the mechanics of photoreceptor degeneration and the possible beneficial effects of supplementation with retinal carotenoids, particularly lutein.

The supplement that will be used in this study will be the commercially available Visionace Plus (details attached). The manufacturer of Visionace Plus is Vitabiotics. The placebo will be soya-based, also manufactured by Vitabiotics.

Study Timeline

• Study Start: 2011-11
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Study First Posted: 2014-05-26
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Not on food supplements containing lutein or zeaxanthin

2. Visual acuity at least 0.4 logMAR units (6/15 Snellen)

3. Body mass index of less than 35 5. No diagnosed ocular disease (e.g. established AMD, cataract, glaucoma) 6. Age between 50 and 90

Exclusion Criteria

1. Diabetes
2. Any diagnosed ocular disease (e.g. AMD, cataract, glaucoma)
3. Under 50 and over 90 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active lutein group	VisionAce	44 participants taking VisionAce daily for a period of 1 year
Placebo group	Placebo	44 participants taking placebo daily for a period of 1 year

Primary Outcome Measures

Name	Time	Method
Changes in macular pigment optical density	12 months
Changes in serum lutein	12 months

Secondary Outcome Measures

Name	Time	Method
Changes in visual performance	12 months	The following parameters of visual function will be assessed: Visual acuity Contrast Sensitivity Resolution limit Dark adaptation

Trial Locations

Locations (1)

University of Manchester; 🇬🇧 Manchester, United Kingdom