Effects of Sea Buckthorn Oil and Lutein on Eye Health

Turku University Hospital90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Risk Factors for Age Related Macular Degeneration

Interventions

Sea buckthorn oil & luteinDIETARY_SUPPLEMENT

Standardised sea buckthorn seed and pulp oil complemented with lutein

PlaceboDIETARY_SUPPLEMENT

Triglycerides of medium chain fatty acids

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in macular pigment optical density from baseline to 6 mo

measurement of macular pigment optical density

Time frame: 0 mo, 3 mo, 6 mo

Secondary Outcomes

Change in symptoms of dry eye from baseline to 6 mo

questionnaires, symptom logbook

Time frame: 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

Time frame: 0 months, 6 months

Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo

analysis from serum samples

Time frame: 0 months, 6 months

Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo

analysis from plasma samples

Time frame: 0 months, 6 months

Change in contrast sensitivity from baseline to 6 mo

analysis of contrast sensitivity

Time frame: 0 mo, 3 mo, 6 mo

Change in vision aquity from baseline to 6 mo

ETDRS chart

Time frame: 0 mo, 3 mo, 6 mo

Change in vision functioning from baseline to 6 mo

questionnaire

Time frame: 0 mo, 3 mo, 6 mo

Data from ClinicalTrials.gov

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