Effects of Sea Buckthorn Oil and Lutein on Eye Health

Study Overview
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Brief Summary
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Low macular pigment optical density has been associated with increased risk of age-related macular degeneration, an important cause of vision problems in the elderly population. Dry eye is multifactorial disease of tears and the ocular surface associated with symptoms of dryness, grittiness, burning and redness of eyes. The risk of dry eye increases with age. The aim is to investigate the effects of sea buckthorn oil complemented with lutein on eye health, specifically on the macula.

Conditions
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Risk Factors for Age Related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: Sea buckthorn oil & lutein
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - macular pigment optical density equal to or less than 0,40 OD Exclusion Criteria: diabetic retinopathy macular changes associated with high blood pressure signs of macular degeneration: classes 2, 3 and 4 according to the Rotterdam study (Mol Vis 2012: 657-74) severe eye diseases, exluding cataract. The intervention will begina after surgery and recovery from cataract

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sea buckthorn & lutein<br>Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months | Dietary Supplement: Sea buckthorn oil & lutein<br>* Standardised sea buckthorn seed and pulp oil complemented with lutein<br>|
| Placebo Comparator: Placebo<br>Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months | Dietary Supplement: Placebo<br>* Triglycerides of medium chain fatty acids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in macular pigment optical density from baseline to 6 mo | measurement of macular pigment optical density | 0 mo, 3 mo, 6 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of dry eye from baseline to 6 mo | questionnaires, symptom logbook | 0 months, 3 months, 6 months | 
| Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo | analysis from serum samples | 0 months, 6 months | 
| Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo | analysis from serum samples | 0 months, 6 months | 
| Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo | analysis from plasma samples | 0 months, 6 months | 
| Change in contrast sensitivity from baseline to 6 mo | analysis of contrast sensitivity | 0 mo, 3 mo, 6 mo | 
| Change in vision aquity from baseline to 6 mo | ETDRS chart | 0 mo, 3 mo, 6 mo | 
| Change in vision functioning from baseline to 6 mo | questionnaire | 0 mo, 3 mo, 6 mo | 
| Change in tear film osmolarity from baseline to 6 mo | measurement of tear film osmolarity | 0 mo, 3 mo, 6 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular pigment optical density, age related macular degeneration, dry eye, vision