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

Turku University Hospital (TYKS)

Status: Unknown

Conditions: Risk Factors for Age Related Macular Degeneration

Treatments: Dietary Supplement: Sea buckthorn oil & lutein; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02379169

SBEYE

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Sea buckthorn & lutein

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sea buckthorn oil & lutein

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo