The Effects of Blackcurrant Supplementation on Eye Health

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the potential for supplementation with black currant to support eye health among otherwise healthy adult women who spend 6+ hours per day using digital screens.

Detailed Description
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Women who are informed about the study and provide informed consent will be randomized to one of two groups: supplement and placebo. Group assignment will be a 1:1 ratio to supplement (455mg of blackcurrant standardized to 50mg anthocyanins in 2 capsules/day) or placebo (2 capsules/day). Outcomes will be assessed at baseline and again on day 70.

Official Title
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The Effects of Blackcurrant Supplementation on Eye Health: a Randomized, Double Blind, Placebo Controlled Clinical Trial

Conditions
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Eye Strain, Eye Fatigue

Intervention / Treatment
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* Dietary Supplement: Blackcurrant
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 30-60 Lives in the United States Employed full time in an online work environment OR enrolled full time in an online learning environment (average of 6+ hours per day) Ability to understand study instructions Ability to provide informed consent Residence within 100 miles of the study center Exclusion Criteria: Low blood pressure Uncontrolled hypertension (i.e. systolic/diastolic blood pressure > 140/90) Uncontrolled diabetes (i.e. fasting blood glucose >180mg/dl) Any blood clotting disorder Ocular disease Best corrected visual acuity <20/30 Cataracts Renal disease Active hepatitis or cirrhosis Acute or chronic infectious disease Pregnant Breastfeeding Currently trying to conceive Surgical or other invasive procedure planned within the intervention period

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement<br>Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days. | Dietary Supplement: Blackcurrant<br>* Two capsules containing 455mg of CurrantCraft 11% black currant extract.<br>|
| Placebo Comparator: Placebo<br>Participants consume 2 capsules of microcrystalline cellulose for 70 days. | Other: Placebo<br>* Two capsules containing an inert material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ocular discomfort on day 70. | The Ocular Discomfort scale is a validated self reported instrument assessing ocular discomfort symptoms. The scale contains 6 domains with a combination of likert scale (ranging from 1-7) and dichotomous (yes/no) questions. Higher scores indicate greater visual fatigue. | Baseline and day 70 | 
| Change from baseline in visual fatigue on day 70. | The Visual Fatigue scale is a validated self reported instrument assessing visual fatigue symptoms. It is a 6-question scale which asks about immediate symptoms (such as dry eyes). Participants rank their symptoms on a likert scale scored from 1-7, with higher scores indicating more severe symptoms. | Baseline and day 70 | 
| Change from baseline in computer vision symptoms on day 70. | The Computer Vision Symptom scale is a validated self reported instrument assessing computer vision symptoms. The scale measures 17 symptom domains, with scores ranging from 1-4 to 1-7. On each domain, higher scores indicate greater severity. | Baseline and day 70 | 
| Change from baseline in symptoms of computer vision syndrome on day 70. | The Computer Vision Syndrome Questionnaire is a validated self reported instrument assessing computer vision symptoms. The scale measures the presence or absence of 16 symptoms producing scores from 0-16. Higher scores indicate more symptoms. | Baseline and day 70 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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black currant, blackcurrant, Ribes nigrum, digital eye fatigue, eye health, computer vision syndrome, dietary supplement