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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Blood Flow
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Experimental

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal microcirculation via Heidelberg Retinal Flowmeter	Measures retinal capillary blood flow	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular perfusion pressure	intraocular pressure and blood pressure	3 weeks
Retinal photographic oximetry	Measures oxygen content in retinal arteries and veins	3 weeks

Collaborators and Investigators

• Sponsor: LycoRed Ltd.
• Collaborators: Indiana University School of Medicine
• Investigators: Principal Investigator: Alon Harris, MS, PhD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: February 26, 2017
• First Submitted That Met QC Criteria: February 26, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: eye; lycopene; vessel function
• Other Study ID Numbers: LYC-001e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No