Meso-zeaxanthin Ocular Supplementation Trial (MOST)
| ISRCTN | ISRCTN60816411 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60816411 |
| Secondary identifying numbers | NA |
- Submission date
- 05/09/2008
- Registration date
- 23/10/2008
- Last edited
- 07/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr John Nolan
Scientific
Scientific
Macular Pigment Research Group
Chemical and Life Sciences Department
Waterford Institute of Technology
Cork Road
Waterford
-
Ireland
| jnolan@wit.ie |
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information sheet can be found at http://www.wit.ie/mprg |
| Scientific title | Macular and serum responses to supplemental Meso-zeaxanthin, Lutein and Zeaxanthin (Macushield™/MacuHealth with LMZ) |
| Study acronym | MOST |
| Study hypothesis | Age-related macular degeneration (AMD) is the most common cause of blind registration in the western world. It is estimated that AMD affects approximately 1.4 million individuals in the United States, 417,000 people in the United Kingdom and 70,000 people in the Republic of Ireland, and this number is likely to increase due to increasing longevity. Although the aetiological mechanisms leading to AMD are uncertain, there is a growing consensus that cumulative short wavelength (blue) light damage and/or oxidative stress play a role. The central retina, known as the macula, is responsible for central, colour and fine-detail vision. A pigment, composed of the three dietary hydroxycarotenoids, meso-zeaxanthin (MZ), lutein (L) and zeaxanthin (Z) (MZ is also formed in the retina following conversion from L), accumulates at the macula where it is known as macular pigment (MP). MP is a blue light filter and a powerful antioxidant, and is therefore believed to protect against AMD. In addition, there is good reason to believe why supplementation with MZ, L and Z would enhance a patient's retinal sensitivity. Several studies have investigated the relationship between dietary and serum concentrations of L (and Z) and MP optical density in humans, and all have demonstrated a positive relationship between these variables. Non-dietary variables suspected of acting as determinants of serum concentrations of L (and Z) and/or MP optical density include: age; sex; iris colour; race; body fat; ultraviolet light exposure; cumulative visible light exposure; tobacco and drinking habits; and genetic background. However, the exclusively dietary origins of L and Z suggest that dietary intake (fruit and vegetables and/or dietary supplements) of these carotenoids represents one of the most important determinants of serum L (and Z) and MP optical density. To date, there have been several published studies in the literature reporting on L and/or Z supplementation with respect to serum carotenoid and MP levels, in human subjects. In 1997, Hammond et al. showed that dietary modification, for as little as four weeks, could augment MP, with this effect being maintained for several months following resumption of a normal, unmodified diet. Of note, two of the 11 subjects involved in that study did not show a significant rise in MP optical density despite a significant increase in serum L. These subjects were termed "retinal non-responders" and this phenomenon may be due to a compromised ability to capture and/or stabilise the macular carotenoids in these individuals. Landrum et al. investigated the effect of L supplementation in two individuals over a 140 day period. They found an increase in serum L levels in both individuals, coupled with a parallel increase in MP optical density. Most recently, a study by Trieschmann et al. concluded that supplementation with 12 mg L and 1 mg Z, combined with co-antioxidants, resulted in a significant increase in MP optical density in a majority of subjects. However, there has only been one study which has investigated the effects of supplemental MZ and that study consisted of only 10 subjects and nine controls which were recruited in a non-randomised manner. MZ is a particularly interesting macular carotenoid for the following reasons: 1. MZ is the dominant carotenoid in the central fovea: of the three macular carotenoids, MZ is the most powerful antioxidant in the presence of its binding protein 2. MZ facilitates a wider range of blue light filtration 3. At an anatomic level, MZ is more closely related to vulnerable photoreceptors than either L or Z, and is therefore ideally located to afford protection against free radical damage. In addition, the design of all studies to date are limited, as no study has yet investigated supplementation of any macular carotenoid in subjects using a double-blind randomised placebo controlled design. Also, all supplementation studies to date have reported only on the peak MP optical density. This is a major limitation, due to the fact that most of the studies to date would have supplemented with L only, and it is known that L accumulates in the periphery of the MP and not at the centre where these measurements would have been made. In other words, it is likely that previous studies reporting on L supplementation with respect to MP levels would have missed (or were unable to detect) significant increases in peripheral MP levels. In brief, therefore, a properly designed study capable of investigating MZ, L and Z supplementation with respect to serum and MP levels (including its entire spatial profile), in human subjects is truly merited. This study is designed to investigate (in a double-blind, randomised placebo controlled fashion) changes in MP optical density (including its entire spatial profile), and in serum concentrations of MZ, L and Z, in response to supplementation with MacuShield™/MacuHealth with LMZ (a specialised, comprehensive formula of MZ, L and Z) in normal subjects, and investigate whether MP augmentation in such subjects enhances retinal sensitivity. Please note that, as of 21/01/2009, the public title of this trial has been amended from "Human response to Macushield™/MacuHealth with LMZ" to "Meso-zeaxanthin Ocular Supplementation Trial (MOST)". Acronym has also been changed from "MZ Trial" to "MOST". |
| Ethics approval(s) | Granted by the Research Ethics Committee in the Waterford Regional Hospital, Ireland on the 11th August 2008. |
| Condition | Age-related macular degeneration (AMD) |
| Intervention | Patients were randomised to: 1. Intervention group: one tablet of Macushield™/MacuHealth with LMZ (dosage: 10 mg L, 10 mg MZ, 2 mg Z) orally, once daily 2. Control group: one tablet of placebo (rice flour) orally, once daily The total duration of treatment was six months, the total duration of follow-up was three months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Macushield™/MacuHealth with LMZ (Meso-zeaxanthin, Lutein and Zeaxanthin) |
| Primary outcome measure | MP optical density (including its entire spatial profile), as measured by heterochromatic flicker photometry [HFP]. Primary and secondary outcome measures will be carried out at baseline, three, six and nine months. |
| Secondary outcome measures | 1. Assessment of retinal sensitivity using microperimetry 2. Serum L and Z (including MZ) concentrations as measured by high-performance liquid chromatography [HPLC] 3. Comparison of MP optical density values measured using the validated gold standard customised HFP device (Densitometer™) to MP optical density values obtained using a MP screening device (MacuScope™) Primary and secondary outcome measures will be carried out at baseline, three, six and nine months. |
| Overall study start date | 01/10/2008 |
| Overall study end date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Any race 2. Male or female 3. Aged 18 to 60 years 4. No presence of ocular pathology 5. Visual acuity of at least 6/18 in the study eye |
| Participant exclusion criteria | 1. Outside age range 18 to 60 years 2. Pregnancy 3. Presence of ocular pathology |
| Recruitment start date | 01/10/2008 |
| Recruitment end date | 01/01/2010 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Macular Pigment Research Group
Waterford
-
Ireland
-
Ireland
Sponsor information
Macuvision Europe Limited (UK)
Industry
Industry
c/o Trevor McCormack
122 Station Lane
Lapworth, Solihull
West Midlands
B94 6JJ
United Kingdom
| Phone | +44 (0)1564 783753 |
|---|---|
| trevormccormack1@btconnect.com | |
| Website | http://www.macushield.com |
"ROR" |
https://ror.org/001zd1d95 |
Funders
Funder type
Industry
Macuvision Europe Ltd (UK)
No information available
MacuHealth US (USA)
No information available
MacuHealth Canada (Canada)
No information available
Macuscope US (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/11/2011 | Yes | No |
