Effects of Sea Buckthorn Oil and Lutein on Eye Health

Not Applicable

• Conditions: Risk Factors for Age Related Macular Degeneration
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Sea buckthorn oil & lutein

• Registration Number: NCT02379169
• Lead Sponsor: Turku University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-07
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-26
• Last Update Submitted: 2015-02-26
• Study First Posted: 2015-03-04
• Last Update Posted: 2015-03-04
• Primary Completion: 2017-02
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months
Sea buckthorn & lutein	Sea buckthorn oil & lutein	Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months

Primary Outcome Measures

Name	Time	Method
Change in macular pigment optical density from baseline to 6 mo	0 mo, 3 mo, 6 mo	measurement of macular pigment optical density

Secondary Outcome Measures

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