{"type":"trials","record":{"id":41957,"source_id":"clinicaltrials-gov","external_id":"NCT06391411","title":"Effect of Micronutrient Supplementation on the Intestinal Microbiota in Patients With Age-related Macular Degeneration - The Gut-Retina-axis Study","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","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Azienda Ospedaliero-Universitaria Careggi","enrollment":45,"countries":["Italy"],"start_date":"2021-03-01","completion_date":"2024-05-01","last_update_date":"2024-07-31","source_url":"https://clinicaltrials.gov/study/NCT06391411","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"50 Years","comparator":"Control; Aflibercept 2 mg, 0.05 ml","organization":"Azienda Ospedaliero-Universitaria Careggi","interventions":["a micronutrient mix containing lutein (10 mg), zeaxanthin (2 mg), saffron (20 mg), vitamin C (80 mg), vitamin E (12 mg)…","anti-VEGF treatment"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Changes in gut microbiota composition — At baseline and at month 6","Changes in gut microbiota function — At baseline and at month 6","Ophthalmological examination — At baseline and at month 6","White blood cells — At baseline and at month 6","Red blood cells — At baseline and at month 6","Hemoglobin — At baseline and at month 6","Platelets — At baseline and at month 6","Glucose — At baseline and at month 6","HDL-cholesterol — At baseline and at month 6","LDL-cholesterol — At baseline and at month 6","Triglycerides — At baseline and at month 6","Evaluation of Interleukin-6 — At baseline and at month 6","Evaluation of Interleukin-10 — At baseline and at month 6","Evaluation of tumor necrosis factor-α (TNF-α) — At baseline and at month 6"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":false},"controlled_terms":["Age-Related Macular Degeneration","a micronutrient mix containing lutein (10 mg), zeaxanthin (2 mg), saffron (20 mg), vitamin C (80 mg), vitamin E (12 mg)…","anti-VEGF treatment"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct06391411","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2021-03-01 to 2024-05-01","comparator":"Control; Aflibercept 2 mg, 0.05 ml","confidence":"structured-source","population":"ALL · 50 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.899Z","intervention":["a micronutrient mix containing lutein (10 mg), zeaxanthin (2 mg), saffron (20 mg), vitamin C (80 mg), vitamin E (12 mg)…","anti-VEGF treatment"],"participants":45,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Changes in gut microbiota composition — At baseline and at month 6","Changes in gut microbiota function — At baseline and at month 6","Ophthalmological examination — At baseline and at month 6","White blood cells — At baseline and at month 6","Red blood cells — At baseline and at month 6","Hemoglobin — At baseline and at month 6","Platelets — At baseline and at month 6","Glucose — At baseline and at month 6","HDL-cholesterol — At baseline and at month 6","LDL-cholesterol — At baseline and at month 6","Triglycerides — At baseline and at month 6","Evaluation of Interleukin-6 — At baseline and at month 6","Evaluation of Interleukin-10 — At baseline and at month 6","Evaluation of tumor necrosis factor-α (TNF-α) — At baseline and at month 6"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41957","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}