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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

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE March 4, 2015
Last Update Posted Date March 4, 2015
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
  • Change in symptoms of dry eye from baseline to 6 mo [ Time Frame: 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 [ Time Frame: 0 months, 6 months ]
    analysis from serum samples
  • Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo [ Time Frame: 0 months, 6 months ]
    analysis from serum samples
  • Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo [ Time Frame: 0 months, 6 months ]
    analysis from plasma samples
  • Change in contrast sensitivity from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    analysis of contrast sensitivity
  • Change in vision aquity from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    ETDRS chart
  • Change in vision functioning from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    questionnaire
  • Change in tear film osmolarity from baseline to 6 mo [ Time Frame: 0 mo, 3 mo, 6 mo ]
    measurement of tear film osmolarity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 26, 2015)
Change in serum markers of sea buckthorn oil and lutein intake [ Time Frame: 0 months, 6 months ]
analysis from serum samples
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Sea Buckthorn Oil and Lutein on Eye Health
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Risk Factors for Age Related Macular Degeneration
Intervention  ICMJE
  • Dietary Supplement: Sea buckthorn oil & lutein
    Standardised sea buckthorn seed and pulp oil complemented with lutein
  • Dietary Supplement: Placebo
    Triglycerides of medium chain fatty acids
Study Arms  ICMJE
  • Experimental: Sea buckthorn & lutein
    Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months
    Intervention: Dietary Supplement: Sea buckthorn oil & lutein
  • Placebo Comparator: Placebo
    Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 26, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02379169
Other Study ID Numbers  ICMJE SBEYE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Turku University Hospital
Study Sponsor  ICMJE Turku University Hospital
Collaborators  ICMJE Aromtech Ltd.
Investigators  ICMJE Not Provided
PRS Account Turku University Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP