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

NCT03068377 | Completed

• 1 other identifier: LYC-001e
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Blood Flow

Keywords

lycopene; eye; vessel function

Outcome Measures

Primary Outcomes (1)

• Retinal microcirculation via Heidelberg Retinal Flowmeter

  Measures retinal capillary blood flow

  3 weeks

Secondary Outcomes (2)

• Ocular perfusion pressure

  3 weeks

• Retinal photographic oximetry

  3 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Soft gel capsules without test material

Dietary Supplement: Placebo

Experimental

EXPERIMENTAL

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

Dietary Supplement: Experimental

Interventions

Experimental DIETARY_SUPPLEMENT

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

Experimental

Placebo DIETARY_SUPPLEMENT

soft gel capsules without test material

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LycoRed Ltd.: lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Alon Harris, MS, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomized double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-phase, randomized, parallel, double blind , comparative study of LYC-001e versus placebo on ocular blood vessels in healthy individuals

Study Record Dates

• First Submitted: February 26, 2017
• First Posted: March 1, 2017
• Study Start: March 20, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 30, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)