The Effects of Blackcurrant Supplementation on Eye Health

NCT ID: NCT04775654

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Eye Strain Eye Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and the individuals providing informed consent are masked.

Study Groups

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Supplement

Participants consume 455mg of blackcurrant extract standardized to contain 50mg anthocyanins in a 2-capsule dose for 70 days.

Group Type EXPERIMENTAL

Blackcurrant

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Participants consume 2 capsules of microcrystalline cellulose for 70 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Two capsules containing an inert material.

Interventions

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Blackcurrant

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Two capsules containing an inert material.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Artemis International

UNKNOWN

Sponsor Role collaborator

Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessie R Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Franklin Health Research & Education Center

Locations

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Franklin Health Research Center

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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21-02-7800

Identifier Type: -

Identifier Source: org_study_id

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