Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391411
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-04-16
Brief Title:
Effect of Micronutrient Supplementation on the Intestinal Microbiota in Patients With Age-related Macular Degeneration - The Gut-Retina-axis Study
Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Organization:
Azienda Ospedaliero-Universitaria Careggi
Study Overview
Official Title:
Effect of Supplementation With Lutein Zeaxanthin and Saffron on the Intestinal Microbiota in Patients Suffering From Age-related Macular Degeneration - The Gut-Retina-axis Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Age-related macular degeneration AMD is a leading cause of visual impairment in the elderly characterized by multifactorial etiology Recent evidence suggests a potential involvement of the gut-retina axis in AMD pathogenesis prompting exploration into novel therapeutic strategies The investigators assessed the effects of a micronutrient mix containing lutein zeaxanthin and saffron recognized for their anti-inflammatory properties on ophthalmological and microbial parameters in neovascular AMD nAMD patients Thirty nAMD subjects were randomized to receive daily micronutrient supplementation along with anti-VEGF therapy or anti-VEGF treatment alone for 6 months Ophthalmological assessments anthropometric and biochemical measurements and stool samples were obtained pre- and post-treatment Gut microbiota GM characterization was performed through 16S rRNA sequencing while short SCFAs medium MCFAs and long LCFAs chain fatty acids were analyzed with a gas chromatography-mass spectrometry protocol nAMD patients exhibited reduced GM alpha diversity altered taxonomic abundances and decreased total SCFA amount coupled with elevated proinflammatory octanoic and nonanoic acids Micronutrient supplementation led to improved visual acuity in comparison to the control group along with the reduction in the total amount of MCFAs metabolites exerting detrimental ocular effects This study reveals compositional and functional imbalances in the GM of nAMD patients compared to healthy controls Furthermore micronutrient supplementation demonstrated a potential to restore the gut-retina axis suggesting its therapeutic efficacy in improving ocular outcomes in nAMD patients These findings underscore the intricate interplay between the GM and ocular health offering insights into innovative interventions for AMD management
Detailed Description:
Age-related macular degeneration AMD stands as the primary cause of visual impairment in the over-65-year-old population of industrialized countries affecting approximately 170 million people worldwide AMD is a multifactorial disease in the pathogenesis of which that its not yet fully understood genetic and environmental factors are involved Specifically there are two main types of AMD both culminating in central vision deficiency and potential blindness due to the death of photoreceptors The first type of AMD type known as dry AMD is characterized by the accumulation of extracellular material ie lipids vitronectin inflammatory or amyloid proteins between the Bruchs membrane and the retinal pigment epithelium leading to the formation of drusen Drusen are small yellow or white spots on the retina that can gradually evolve either into retinal and pigment epithelium atrophy or for approximately 20 of patients progress into the second AMD type that is called wet AMD or neovascular AMD nAMD nAMD is distinguished by the development of new choroidal vessels a condition that can result in permanent visual impairment Presently although therapeutic options for dry AMD are limited nAMD is treated with intravitreal injections of anti-VEGF vascular endothelial growth factor drugs which have proven effective in slowing angiogenic development and limiting the progression of nAMD Moreover recent investigations have implicated immune system alterations oxidative stress and overweight as critical factors in AMD pathogenesis Particularly many studies have recently highlighted the potential benefits of dietary supplementation with micronutrients having antioxidant and antiinflammatory effects in reducing the risk of AMD development Notably the AREDS2 study definitively demonstrated the efficacy of dietary supplementation with lutein and zeaxanthin in reducing the risk of progression of early-stage AMD In detail the administration of lutein and zeaxanthin which can absorb blue light and neutralize free radicals and reactive oxygen species in the macula has been associated with increased macular pigment optical density MPOD improved visual acuity and a reduced risk of retinal aging Moreover other micronutrients such as vitamins E and C can prevent the progression of maculopathy by providing protection against oxidative stress and maintaining GM homeostasis while oral zinc supplementation can reduce the complement-mediated inflammation in the retinal pigment epithelium which plays a fundamental role in the etiology of AMD Additionally saffron Crocus sativus which contains active components such as crocin safranal crocetin and picrocrocin has demonstrated antioxidant and anti-inflammatory effects leading to significant improvements in the retinal function of AMD patients Furthermore considering that the retina is an extension of the brain both anatomically and developmentally the hypothesis of a gut-retina interplay has been recently proposed paralleling the widely explored bidirectional communication between the gut and the brain Objectives of the study To evaluate the GM composition and function of nAMD patients in comparison to healthy subjects and considering the dual potential of micronutrients to act through direct antioxidant mechanisms and modulation of the GM the investigators assessed the impact of a novel micronutrient supplementation based on lutein zeaxanthin and saffron on ophthalmological parameters and microbial features of nAMD patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None