The Effects of Blackcurrant Supplementation on Eye Health

Eye Strain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775654
• Other study ID #: 21-02-7800
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Franklin Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenopia
• Eye Fatigue
• Eye Strain
• Fatigue

Intervention

Dietary Supplement:
• Blackcurrant
Two capsules containing 455mg of CurrantCraft 11% black currant extract.

Other:
• Placebo
Two capsules containing an inert material.

Locations

Country	Name	City	State
United States	Franklin Health Research Center	Franklin	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Franklin Health Research	Artemis International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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