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Carotenoid Supplementation and Normal Ocular Health

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ClinicalTrials.gov Identifier: NCT02147171
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : May 26, 2014
Sponsor:
Information provided by (Responsible Party):
Laura Patryas, University of Manchester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Retinal Ageing Dietary Supplement: VisionAce Dietary Supplement: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Bioavailability of Retinal Carotenoids in the Older Human Eye and Their Effects on Photoreceptor Performance
Study Start Date : November 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active lutein group
44 participants taking VisionAce daily for a period of 1 year
 Dietary Supplement: VisionAce
Placebo Comparator: Placebo group
44 participants taking placebo daily for a period of 1 year
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Changes in macular pigment optical density [ Time Frame: 12 months ]
  2. Changes in serum lutein [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Changes in visual performance [ Time Frame: 12 months ]

    The following parameters of visual function will be assessed:

    Visual acuity Contrast Sensitivity Resolution limit Dark adaptation



Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Not on food supplements containing lutein or zeaxanthin
  2. Visual acuity at least 0.4 logMAR units (6/15 Snellen)

4. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147171


Locations
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United Kingdom
University of Manchester
Manchester, United Kingdom, M13 9PL
Sponsors and Collaborators
University of Manchester
Investigators
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Study Director: Ian Murray University of Manchester
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Laura Patryas, Miss, University of Manchester
ClinicalTrials.gov Identifier: NCT02147171    
Other Study ID Numbers: BB/F017227/1
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: May 26, 2014
Last Verified: April 2014
Keywords provided by Laura Patryas, University of Manchester:
Retinal ageing, macular pigment, visual function