Eye StrainNCT04775654
The Effects of Blackcurrant Supplementation on Eye Health
A study testing Blackcurrant in people with Eye Strain and Eye Fatigue, run by Nutraceuticals Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eye Strain, Eye Fatigue
- What is being tested?
- Blackcurrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Health Research Center
Franklin, Tennessee, 37067
About this study
Official title: 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.
Read the 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.
- Conditions
- Eye Strain, Eye Fatigue
- Being tested
- Blackcurrant, Placebo
- Keywords
- black currant, blackcurrant, Ribes nigrum, digital eye fatigue, eye health, computer vision syndrome, dietary supplement
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlackcurrantDietary supplement
Two capsules containing 455mg of CurrantCraft 11% black currant extract.
PlaceboOther
Two capsules containing an inert material.
| Study group | Role | What they receive |
|---|---|---|
| Supplement | Experimental | Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days. Receives: Dietary Supplement: Blackcurrant |
| Placebo | Placebo comparator | Participants consume 2 capsules of microcrystalline cellulose for 70 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Artemis International
- Responsible party
- Sponsor
- Investigators
- Jessie R Hawkins, PhD, Principal investigator, Franklin Health Research & Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775654
- Sponsor's protocol ID
- 21-02-7800
- Status last verified
- Jan 2022
- First submitted
- 25 Feb 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blackcurrant Supplementation on Eye Health: a Randomized, Double Blind, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04775654
- Acronym / sponsor ID
- 21-02-7800
- Conditions
- Eye Strain, Eye Fatigue
- Keywords
- black currant, blackcurrant, Ribes nigrum, digital eye fatigue, eye health, computer vision syndrome, dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Collaborators
- Artemis International
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement | Experimental | Dietary Supplement: BlackcurrantParticipants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days. |
| Placebo | Placebo comparator | Other: PlaceboParticipants consume 2 capsules of microcrystalline cellulose for 70 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlackcurrantTwo capsules containing 455mg of CurrantCraft 11% black currant extract. | Dietary supplement | Supplement |
| PlaceboTwo capsules containing an inert material. | Other | Placebo |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessie R Hawkins, PhD principal investigator
Franklin Health Research & Education Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blackcurrant in people with Eye Strain and Eye Fatigue, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ocular discomfort on day 70. (time frame: Baseline and day 70). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.