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The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow

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ClinicalTrials.gov Identifier: NCT03068377
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
LycoRed Ltd.

Brief Summary:

Objectives:To determine LYC-001e's influences on ocular blood flow Ocular blood flow has been implicated as a parameter relevant to eye health and involved in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes We hypothesis that LYC-001e will increase measures of ocular blood flow in healthy individuals

Methods: This is a single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals.


Condition or disease Intervention/treatment Phase
Ocular Blood Flow Dietary Supplement: Experimental Dietary Supplement: Placebo Not Applicable

Detailed Description:

Age-Related Eye Disease (ARED) is a group of conditions that are associated with an increased risk of manifesting later in life, and include: Age-related Macular Degeneration (AMD), cataract, diabetic retinopathy, glaucoma, dry eye, and low vision. AMD and cataract are the leading causes of visual impairment in the United States. According to the National Eye Institute, approximately 1.7 million Americans suffer from some form of AMD, and over 1.5 million cataract surgeries are performed annually.

Although there are established risk factors, such as smoking and diabetes, cataracts are generally considered a consequence of ageing. The National Eye Institute estimates more than half of Americans will have cataracts or have had cataract surgery by the time they reach 80 years old. Additionally, AMD is the leading cause of central vision loss in developed countries and affects 13.4% of all adults aged 60 years and older.

It is estimated that the number of patients with AMD in the U.S. will double in 2050, based on 2010 demographics.

The severity and irreversibility of ocular pathology have created interest in researching ways to either prevent or slow their progression. Nutritional methods have been demonstrated to improve microvascular function in hypertensive patients, however diet modifications are infrequently well established and maintained in the American population.

Over the last 15 years, researchers focused on the role of the AREDS vitamin formulation on age related eye disease, specifically as it pertains to the development and progression of AMD and cataracts. While the benefit of AREDS supplementation has proven beneficial for AMD, its role in the prevention of cataract and/or glaucoma development has not been confirmed. However, with evidence suggesting that some combination supplements do provide potential risk reduction, it is our belief that further studies are needed to elucidate the role of combination nutriceuticals for the prevention of cataracts.

Lycored Nutrient Complex for eyes (LNC for eyes) a.k.a. (LYC-001e) is a commercially available multivitamin formula nutraceutical product that also contains a standardized tomato extract. Research by Armoza, et al. has shown multiple benefits of tomato extract as it pertains to limiting inflammatory processes of the vascular endothelium. Along with the previously mentioned benefits of nutraceuticals, diminished endothelial damage may result in increased ocular blood flow and alter the progression of Age Related Eye Diseases.

This is an important research consideration as ocular blood flow has been implicated in the disease process of several ophthalmic pathologies including AMD, glaucoma, and diabetes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: randomized double blind
Primary Purpose: Supportive Care
Official Title: The Effects of LycoRed Phytonutrient and Vitamin Supplement (a.k.a. LYC-001e) on Ocular Blood Flow
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : December 30, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Soft gel capsules without test material
Dietary Supplement: Placebo
soft gel capsules without test material

Experimental: Experimental
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
Dietary Supplement: Experimental
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins




Primary Outcome Measures :
  1. Retinal microcirculation via Heidelberg Retinal Flowmeter [ Time Frame: 3 weeks ]
    Measures retinal capillary blood flow


Secondary Outcome Measures :
  1. Ocular perfusion pressure [ Time Frame: 3 weeks ]
    intraocular pressure and blood pressure

  2. Retinal photographic oximetry [ Time Frame: 3 weeks ]
    Measures oxygen content in retinal arteries and veins



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females of 18 years of age or older and free of any eye disease (other than myopia)
  • Willing to sign an informed consent statement and able to comply with the requirements of the examination

Exclusion Criteria:

  • Women who are pregnant or lactating or who plan to become pregnant (self reporting) within the duration of the study or within one month after study completion.

    • Receiving medications or dietary supplements known to have any interaction with the study supplements.
    • Smoker during last ten years (self reporting)
    • Concurrent use of any of the components of the study supplement
    • Individuals with narrow anterior chamber angles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068377


Locations
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United States, Indiana
Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
LycoRed Ltd.
Indiana University School of Medicine
Investigators
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Principal Investigator: Alon Harris, MS, PhD Indiana University School of Medicine
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Responsible Party: LycoRed Ltd.
ClinicalTrials.gov Identifier: NCT03068377    
Other Study ID Numbers: LYC-001e
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LycoRed Ltd.:
lycopene
eye
vessel function