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

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ClinicalTrials.gov Identifier: NCT02379169
Recruitment Status : Unknown
Verified November 2014 by Turku University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Collaborator:
Aromtech Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Risk Factors for Age Related Macular Degeneration Dietary Supplement: Sea buckthorn oil & lutein Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : February 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in symptoms of dry eye from baseline to 6 mo [ Time Frame: 0 months, 3 months, 6 months ]
    questionnaires, symptom logbook

  2. 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

  3. Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo [ Time Frame: 0 months, 6 months ]
    analysis from serum samples

  4. Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo [ Time Frame: 0 months, 6 months ]
    analysis from plasma samples

  5. Change in contrast sensitivity from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    analysis of contrast sensitivity

  6. Change in vision aquity from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    ETDRS chart

  7. Change in vision functioning from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    questionnaire

  8. Change in tear film osmolarity from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    measurement of tear film osmolarity


Other Outcome Measures:
  1. Change in serum markers of sea buckthorn oil and lutein intake [ Time Frame: 0 months, 6 months ]
    analysis from serum samples



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02379169    
Other Study ID Numbers: SBEYE
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: November 2014
Keywords provided by Turku University Hospital:
macular pigment optical density, age related macular degeneration, dry eye, vision
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases