- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03068377
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Glaucoma Research and Diagnostic Center Eugene and Marilyn Glick Eye Institute Indiana University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Soft gel capsules without test material
|
soft gel capsules without test material
|
|
Eksperimentel: Experimental
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
|
Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Retinal microcirculation via Heidelberg Retinal Flowmeter
Tidsramme: 3 weeks
|
Measures retinal capillary blood flow
|
3 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ocular perfusion pressure
Tidsramme: 3 weeks
|
intraocular pressure and blood pressure
|
3 weeks
|
|
Retinal photographic oximetry
Tidsramme: 3 weeks
|
Measures oxygen content in retinal arteries and veins
|
3 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alon Harris, MS, PhD, Indiana University School of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- LYC-001e
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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