Effects of Sea Buckthorn Oil and Lutein on Eye Health
SBEYE
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMarch 4, 2015
November 1, 2014
2 years
November 7, 2014
February 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in macular pigment optical density from baseline to 6 mo
measurement of macular pigment optical density
0 mo, 3 mo, 6 mo
Secondary Outcomes (8)
Change in symptoms of dry eye from baseline to 6 mo
0 months, 3 months, 6 months
Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo
0 months, 6 months
Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo
0 months, 6 months
Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo
0 months, 6 months
Change in contrast sensitivity from baseline to 6 mo
0 mo, 3 mo, 6 mo
- +3 more secondary outcomes
Other Outcomes (1)
Change in serum markers of sea buckthorn oil and lutein intake
0 months, 6 months
Study Arms (2)
Sea buckthorn & lutein
EXPERIMENTALSea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months
Placebo
PLACEBO COMPARATORTriglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months
Interventions
Standardised sea buckthorn seed and pulp oil complemented with lutein
Eligibility Criteria
You may qualify if:
- \- macular pigment optical density equal to or less than 0,40 OD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Aromtech Ltd.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
March 4, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2017
Study Completion
August 1, 2018
Last Updated
March 4, 2015
Record last verified: 2014-11