Risk Factors for Age Related Macular DegenerationSBEYENCT02379169
Effects of Sea Buckthorn Oil and Lutein on Eye Health
A study testing Sea buckthorn oil & lutein in people with Risk Factors for Age Related Macular Degeneration, run by Turku University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Factors for Age Related Macular Degeneration
- What is being tested?
- Sea buckthorn oil & lutein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- macular pigment optical density equal to or less than 0,40 OD
Who cannot join
- 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
About this study
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.
- Being tested
- Sea buckthorn oil & lutein, Placebo
- Keywords
- macular pigment optical density, age related macular degeneration, dry eye, vision
- Medical subject headings
- Macular Degeneration, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sea buckthorn oil & luteinDietary supplement
Standardised sea buckthorn seed and pulp oil complemented with lutein
PlaceboDietary supplement
Triglycerides of medium chain fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Sea buckthorn & lutein | Experimental | Sea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months Receives: Dietary Supplement: Sea buckthorn oil & lutein |
| Placebo | Placebo comparator | Triglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macular pigment optical density from baseline to 6 mo
measurement of macular pigment optical density
Measured: 0 mo, 3 mo, 6 mo
Secondary outcomes (8)
Change in symptoms of dry eye from baseline to 6 mo
questionnaires, symptom logbook
Measured: 0 months, 3 months, 6 months
Change in serum lipids (Triglycerides, HDL-cholesterol, LDL-cholesterol, total cholesterol) from baseline to 6 mo
analysis from serum samples
Measured: 0 months, 6 months
Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo
analysis from serum samples
Measured: 0 months, 6 months
Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo
analysis from plasma samples
Measured: 0 months, 6 months
Change in contrast sensitivity from baseline to 6 mo
analysis of contrast sensitivity
Measured: 0 mo, 3 mo, 6 mo
Change in vision aquity from baseline to 6 mo
ETDRS chart
Measured: 0 mo, 3 mo, 6 mo
Change in vision functioning from baseline to 6 mo
questionnaire
Measured: 0 mo, 3 mo, 6 mo
Change in tear film osmolarity from baseline to 6 mo
measurement of tear film osmolarity
Measured: 0 mo, 3 mo, 6 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Aromtech Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379169
- Sponsor's protocol ID
- SBEYE
- Acronym
- SBEYE
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sea Buckthorn Oil and Lutein on Eye Health
- ClinicalTrials.gov ID
- NCT02379169
- Acronym / sponsor ID
- SBEYE / SBEYE
- Keywords
- macular pigment optical density, age related macular degeneration, dry eye, vision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Aromtech Ltd.
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sea buckthorn & lutein | Experimental | Dietary Supplement: Sea buckthorn oil & luteinSea buckthorn oil complemented with lutein. Dose: 2 g/day as capsules taken twice/day for 6 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTriglycerides of medium-chain fatty acids. Dose: 2 g/day as capsules taken twice/day for 6 months |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- macular pigment optical density equal to or less than 0,40 OD
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sea buckthorn oil & luteinStandardised sea buckthorn seed and pulp oil complemented with lutein | Dietary supplement | Sea buckthorn & lutein |
| PlaceboTriglycerides of medium chain fatty acids | Dietary supplement | Placebo |
Primary outcome
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
8 secondary outcomes
Change in symptoms of dry eye from baseline to 6 mo
Time frame: 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
Change in serum markers of inflammation (hs-CRP) from baseline to 6 mo
Time frame: 0 months, 6 months
Change in circulating aminotransferases (ALAT, ASAT) from baseline to 6 mo
Time frame: 0 months, 6 months
Change in contrast sensitivity from baseline to 6 mo
Time frame: 0 mo, 3 mo, 6 mo
Change in vision aquity from baseline to 6 mo
Time frame: 0 mo, 3 mo, 6 mo
Change in vision functioning from baseline to 6 mo
Time frame: 0 mo, 3 mo, 6 mo
Change in tear film osmolarity from baseline to 6 mo
Time frame: 0 mo, 3 mo, 6 mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sea buckthorn oil & lutein in people with Risk Factors for Age Related Macular Degeneration, run by Turku University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in macular pigment optical density from baseline to 6 mo (time frame: 0 mo, 3 mo, 6 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.