The Effects of Blackcurrant Supplementation on Eye Health

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

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.

Study Overview

• Status: Completed
• Conditions: Eye Strain; Eye Fatigue
• Intervention / Treatment: Dietary supplement: Blackcurrant; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Health Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Franklin Health Research
• Collaborators: Artemis International
• Investigators: Principal Investigator: Jessie R Hawkins, PhD, Franklin Health Research & Education Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: dietary supplement; black currant; computer vision syndrome; blackcurrant; Ribes nigrum; digital eye fatigue; eye health
• Additional Relevant MeSH Terms: Eye Diseases; Fatigue; Asthenopia
• Other Study ID Numbers: 21-02-7800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No