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

Primary Purpose

Risk Factors for Age Related Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sea buckthorn oil & lutein
Placebo
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Risk Factors for Age Related Macular Degeneration focused on measuring macular pigment optical density, age related macular degeneration, dry eye, vision

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sea buckthorn & lutein

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change in macular pigment optical density from baseline to 6 mo
    measurement of macular pigment optical density

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 7, 2014
    Last Updated
    February 26, 2015
    Sponsor
    Turku University Hospital
    Collaborators
    Aromtech Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379169
    Brief Title
    Effects of Sea Buckthorn Oil and Lutein on Eye Health
    Acronym
    SBEYE
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Turku University Hospital
    Collaborators
    Aromtech Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Risk Factors for Age Related Macular Degeneration
    Keywords
    macular pigment optical density, age related macular degeneration, dry eye, vision

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sea buckthorn & lutein
    Arm Type
    Experimental
    Arm Description
    Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Sea buckthorn oil & lutein
    Intervention Description
    Standardised sea buckthorn seed and pulp oil complemented with lutein
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Triglycerides of medium chain fatty acids
    Primary Outcome Measure Information:
    Title
    Change in macular pigment optical density from baseline to 6 mo
    Description
    measurement of macular pigment optical density
    Time Frame
    0 mo, 3 mo, 6 mo
    Secondary Outcome Measure Information:
    Title
    Change in symptoms of dry eye from baseline to 6 mo
    Description
    questionnaires, symptom logbook
    Time Frame
    0 months, 3 months, 6 months
    Title
    Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo
    Description
    analysis from serum samples
    Time Frame
    0 months, 6 months
    Title
    Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo
    Description
    analysis from serum samples
    Time Frame
    0 months, 6 months
    Title
    Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo
    Description
    analysis from plasma samples
    Time Frame
    0 months, 6 months
    Title
    Change in contrast sensitivity from baseline to 6 mo
    Description
    analysis of contrast sensitivity
    Time Frame
    0 mo, 3 mo, 6 mo
    Title
    Change in vision aquity from baseline to 6 mo
    Description
    ETDRS chart
    Time Frame
    0 mo, 3 mo, 6 mo
    Title
    Change in vision functioning from baseline to 6 mo
    Description
    questionnaire
    Time Frame
    0 mo, 3 mo, 6 mo
    Title
    Change in tear film osmolarity from baseline to 6 mo
    Description
    measurement of tear film osmolarity
    Time Frame
    0 mo, 3 mo, 6 mo
    Other Pre-specified Outcome Measures:
    Title
    Change in serum markers of sea buckthorn oil and lutein intake
    Description
    analysis from serum samples
    Time Frame
    0 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Effects of Sea Buckthorn Oil and Lutein on Eye Health

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