Back to resultsThe Effects of Blackcurrant Supplementation on Eye Health
Primary Purpose
Eye Strain, Eye Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blackcurrant
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Eye Strain focused on measuring black currant, blackcurrant, Ribes nigrum, digital eye fatigue, eye health, computer vision syndrome, dietary supplement
Eligibility Criteria
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
Sites / Locations
- Franklin Health Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Supplement
Placebo
Arm Description
Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days.
Participants consume 2 capsules of microcrystalline cellulose for 70 days.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04775654
First Posted
February 25, 2021
Last Updated
January 20, 2022
Sponsor
Franklin Health Research
Collaborators
Artemis International
1. Study Identification
Unique Protocol Identification Number
NCT04775654
Brief Title
The Effects of Blackcurrant Supplementation on Eye Health
Official Title
The Effects of Blackcurrant Supplementation on Eye Health: a Randomized, Double Blind, Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research
Collaborators
Artemis International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Strain, Eye Fatigue
Keywords
black currant, blackcurrant, Ribes nigrum, digital eye fatigue, eye health, computer vision syndrome, dietary supplement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and the individuals providing informed consent are masked.
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplement
Arm Type
Experimental
Arm Description
Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants consume 2 capsules of microcrystalline cellulose for 70 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blackcurrant
Intervention Description
Two capsules containing 455mg of CurrantCraft 11% black currant extract.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Two capsules containing an inert material.
Primary Outcome Measure Information:
Title
Change from baseline in ocular discomfort on day 70.
Description
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.
Time Frame
Baseline and day 70
Title
Change from baseline in visual fatigue on day 70.
Description
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.
Time Frame
Baseline and day 70
Title
Change from baseline in computer vision symptoms on day 70.
Description
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.
Time Frame
Baseline and day 70
Title
Change from baseline in symptoms of computer vision syndrome on day 70.
Description
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.
Time Frame
Baseline and day 70
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie R Hawkins, PhD
Organizational Affiliation
Franklin Health Research & Education Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin Health Research Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Blackcurrant Supplementation on Eye Health
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