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Completed

NCT Number: NCT04775654

The Effects of Blackcurrant Supplementation on Eye Health

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.

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Key information

Conditions

Eye Strain Asthenopia Eye Diseases Eye Fatigue

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blackcurrant

Dietary Supplement

Two capsules containing 455mg of CurrantCraft 11% black currant extract.

Placebo

Other

Two capsules containing an inert material.

Primary outcomes

  1. Change from baseline in ocular discomfort on day 70.

    Time frame: 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.

  2. Change from baseline in visual fatigue on day 70.

    Time frame: 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.

  3. Change from baseline in computer vision symptoms on day 70.

    Time frame: 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.

  4. Change from baseline in symptoms of computer vision syndrome on day 70.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Collaborators

  • Artemis International

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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