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NCT06391411Completed

Effect of Micronutrient Supplementation on the Intestinal Microbiota in Patients With Age-related Macular Degeneration - The Gut-Retina-axis Study

: 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"

Source: ClinicalTrials.gov · Last updated 31 Jul 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
45 (actual)
First submitted
16 Apr 2024
Start date
1 Mar 2021
Primary completion date
1 Mar 2022
Lead sponsor
Azienda Ospedaliero-Universitaria Careggi
NCT number
NCT06391411

What you commit to

  • Study type: Interventional
  • Participants enrolled: 45
  • From 1 Mar 2021 to the primary completion date, 1 Mar 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of antibiotics or continued use of pre- or probiotics in the 2 months before enrolment
  • Use of other treatments (medications or nutritional programs) that affect body weight, food intake, and/or energy expenditure

Other illness

  • Diagnosis of any ocular disease.

Who the study is looking for

  • Men and women \>50 years of age.
  • Willingness to cooperate during the study and ability to follow guidelines and to complete all clinical visits
  • Ability to provide informed consent

Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Unit of Clinical Nutrition, University Hospital of Careggi
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.