Effects of Sea Buckthorn Oil and Lutein on Eye Health

NCT ID: NCT02379169

Last Updated: 2015-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-08-31

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.

Detailed Description

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Conditions

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Risk Factors for Age Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sea buckthorn & lutein

Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months

Group Type EXPERIMENTAL

Sea buckthorn oil & lutein

Intervention Type DIETARY_SUPPLEMENT

Standardised sea buckthorn seed and pulp oil complemented with lutein

Placebo

Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Triglycerides of medium chain fatty acids

Interventions

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Sea buckthorn oil & lutein

Standardised sea buckthorn seed and pulp oil complemented with lutein

Intervention Type DIETARY_SUPPLEMENT

Placebo

Triglycerides of medium chain fatty acids

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aromtech Ltd.

INDUSTRY

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SBEYE

Identifier Type: -

Identifier Source: org_study_id

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