Effects of Sea Buckthorn Oil on Dry Eye

Overview

The objective is to study the effect of sea buckthorn oil on dry eye.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2009

Detailed Description

The objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3 months. The dry eye symptoms will be monitored during the study using a validated questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood samples for the analyses of inflammatory markers are also obtained. The cytokine and other inflammation marker analyses are optional. The symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.

Interventions

  • Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
    • Dosage 2 g/d, frequency twice/d, duration 3 months
  • Dietary Supplement: Placebo comparison
    • Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Arms, Groups and Cohorts

  • Experimental: SB
    • Sea buckthorn oil group
  • Placebo Comparator: PL
    • Placebo group

Clinical Trial Outcome Measures

Primary Measures

  • Symptom severity: symptom questionnaires and clinical dry eye tests
    • Time Frame: 3 months intervention + 1 month after the intervention

Secondary Measures

  • Tear film lipid profile, tear cytokines, inflammation mediators in blood
    • Time Frame: 3 months intervention + 1 month after the intervention

Participating in This Clinical Trial

Inclusion Criteria

  • Dry eye symptoms Exclusion Criteria:

  • Severe illness – Anticholinergic drugs – Smoking

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Turku
  • Collaborator
    • Turku Municipal Health Department/evo-funding
  • Provider of Information About this Clinical Study
    • Matti Viitanen/ Professor, University of Turku
  • Overall Official(s)
    • Heikki P Kallio, Professor, Study Director, University of Turku

References

Yang B, Kalimo KO, Mattila LM, Kallio SE, Katajisto JK, Peltola OJ, Kallio HP. Effects of dietary supplementation with sea buckthorn (Hippophaë rhamnoides) seed and pulp oils on atopic dermatitis. J Nutr Biochem. 1999 Nov;10(11):622-30.

Citations Reporting on Results

Larmo PS, Järvinen RL, Setälä NL, Yang B, Viitanen MH, Engblom JR, Tahvonen RL, Kallio HP. Oral sea buckthorn oil attenuates tear film osmolarity and symptoms in individuals with dry eye. J Nutr. 2010 Aug;140(8):1462-8. doi: 10.3945/jn.109.118901. Epub 2010 Jun 16.

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