The Effects of Blackcurrant Supplementation on Eye Health

Not Applicable

Completed

• Conditions: Eye Fatigue; Eye Strain
• Interventions: Dietary Supplement: Blackcurrant; Other: Placebo

• Registration Number: NCT04775654
• Lead Sponsor: Franklin Health Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study Start: 2021-03-01
• Study First Posted: 2021-03-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplement	Blackcurrant	Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days.
Placebo	Placebo	Participants consume 2 capsules of microcrystalline cellulose for 70 days.

Primary Outcome Measures

Name	Time	Method
Change from baseline in symptoms of computer vision syndrome on day 70.	Baseline and 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.
Change from baseline in visual fatigue on day 70.	Baseline and 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.
Change from baseline in computer vision symptoms on day 70.	Baseline and 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.
Change from baseline in ocular discomfort on day 70.	Baseline and 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.

Trial Locations

Locations (1)

Franklin Health Research Center; 🇺🇸 Franklin, Tennessee, United States