Effects of a Combination of Polyphenol-rich Extracts on the Protection of Retinal Cells Against Blue Light in the Prevention of Ocular Diseases

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-09-30

Brief Summary

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The aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.

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Detailed Description

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Randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. Patients receive one of the investigational products or placebo for 6 weeks. Study parameters: OCT (optical coherence tomography), Amsler test, Computerized Perimetry, Schirmer test. In addition, subjective symptoms will be assessed using the Visual Analog Scale (VAS) method and a Dry Eye-Related Quality-of-Life Questionnaire. The studied parameters will be measured before and after supplementation.

Conditions

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Eye Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Complex product

18 volunteers

Group Type EXPERIMENTAL

Complex product

Intervention Type DIETARY_SUPPLEMENT

Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica, rutin, vitamin B6, vitamin B12, folic acid Single oral dose - 2 capsules

Polyphenol-rich extracts

18 volunteers

Group Type ACTIVE_COMPARATOR

Polyphenol-rich extracts

Intervention Type DIETARY_SUPPLEMENT

Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules

Placebo

18 volunteers

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single oral dose - 2 capsules

Interventions

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Complex product

Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica, rutin, vitamin B6, vitamin B12, folic acid Single oral dose - 2 capsules

Intervention Type DIETARY_SUPPLEMENT

Polyphenol-rich extracts

Extracts from the fruits of Vaccinium myrtillus L. + Aronia Melanocarpa (Michx.) Elliot + Lonicera caerulea var. Kamtschatica Single oral dose - 2 capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo

Single oral dose - 2 capsules

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women and men, 25-45 years old.
* Signed informed consent.
* Volunteers who do not use glasses or contact lenses.
* Volunteers exposed to blue light for at least 6 - 8 hours a day.

Exclusion Criteria

* Intake of supplements containing plant extracts, polyphenols or anthocyanins.
* Participation in another clinical trial.
* Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
* Use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids).
* Current use of eye drops in the treatment of ocular diseases.
* Ocular diseases.

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes