Effects of Sea Buckthorn Oil and Lutein on Eye Health

NCT02379169 — Not applicable, Unknown, 90 participants, Turku University Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT02379169, acronym SBEYE
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	90 (Estimated)
Sponsor	Turku University Hospital (Other gov); collaborators: Aromtech Ltd.
Conditions	Risk Factors for Age Related Macular Degeneration
Interventions	Sea buckthorn oil & lutein, Placebo (Dietary supplement)
Dates	start 2015-02-01, primary completion 2017-02-01 (estimated), completion 2018-08-01 (estimated), first posted 2015-03-04, last updated 2015-03-04

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Sea buckthorn & lutein	Experimental	Dietary Supplement: Sea buckthorn oil & lutein	Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months
Placebo	Placebo comparator	Dietary Supplement: Placebo	Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months

Sea buckthorn oil & lutein (Dietary supplement): Standardised sea buckthorn seed and pulp oil complemented with lutein
Placebo (Dietary supplement): Triglycerides of medium chain fatty acids

+Outcome measures

Primary outcomes

Change in macular pigment optical density from baseline to 6 mo [0 mo, 3 mo, 6 mo]: measurement of macular pigment optical density

Secondary outcomes

Change in symptoms of dry eye from baseline to 6 mo [0 months, 3 months, 6 months]: questionnaires, symptom logbook
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 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

Other outcomes

Change in serum markers of sea buckthorn oil and lutein intake [0 months, 6 months]: analysis from serum samples

+Eligibility

Sex: All, ages: 60 Years to 75 Years, accepts healthy volunteers

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