Effects of Sea Buckthorn Oil and Lutein on Eye Health (SBEYE)

February 26, 2015 updated by: Turku University Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in macular pigment optical density from baseline to 6 mo
Time Frame: 0 mo, 3 mo, 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
Time Frame: 0 months, 3 months, 6 months
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
Time Frame: 0 months, 6 months
analysis from serum samples
0 months, 6 months
Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo
Time Frame: 0 months, 6 months
analysis from serum samples
0 months, 6 months
Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo
Time Frame: 0 months, 6 months
analysis from plasma samples
0 months, 6 months
Change in contrast sensitivity from baseline to 6 mo
Time Frame: 0 mo, 3 mo, 6 mo
analysis of contrast sensitivity
0 mo, 3 mo, 6 mo
Change in vision aquity from baseline to 6 mo
Time Frame: 0 mo, 3 mo, 6 mo
ETDRS chart
0 mo, 3 mo, 6 mo
Change in vision functioning from baseline to 6 mo
Time Frame: 0 mo, 3 mo, 6 mo
questionnaire
0 mo, 3 mo, 6 mo
Change in tear film osmolarity from baseline to 6 mo
Time Frame: 0 mo, 3 mo, 6 mo
measurement of tear film osmolarity
0 mo, 3 mo, 6 mo

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum markers of sea buckthorn oil and lutein intake
Time Frame: 0 months, 6 months
analysis from serum samples
0 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Aromtech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBEYE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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