{"type":"trials","record":{"id":33878,"source_id":"clinicaltrials-gov","external_id":"NCT03824041","title":"Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults","brief_summary":"Aging is the primary risk factor for cardiovascular disease (CVD) largely due to vascular endothelial dysfunction, a major initial step in the development of atherosclerosis. Endothelial dysfunction is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Interventions that improve endothelial dysfunction are important for improving endothelial function and reducing CVD risk in this high-risk population. Aronia melanocarpa, commonly known as aronia berries or chokeberries, are rich in polyphenols such as anthocyanins, proanthocyanidins, and phenolic acids. These compounds, and derivatives resulting from gut microbial and phase II metabolism, have been shown to attenuate oxidative stress and inflammation, and to improve endothelial function. Aronia berries and other berries have been shown in numerous studies to have diverse cardiometabolic health effects including modulation of endothelial function, arterial stiffness, blood pressure, oxidative stress, and inflammation. In addition, berries, dietary fiber, polyphenols have been shown to exert positive effects on the gut microbiota, which may mediate improvements in cardiovascular health. Recently, we have demonstrated that modulation of the gut microbiota is associated with improvements in vascular dysfunction. The primary goal of the currently proposed research is to assess the efficacy and dose-dependent response of an aronia full spectrum dietary supplement to improve endothelial function in middle-aged/older men and postmenopausal women. A secondary goal is to determine whether aronia full spectrum modulation of the gut microbiota is associated with improvements in endothelial function. Other functional and biochemical measures of cardiovascular health, oxidative stress, inflammation, and polyphenol metabolism will be assessed.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Colorado State University","enrollment":24,"countries":["United States"],"start_date":"2019-02-11","completion_date":"2021-07-26","last_update_date":"2023-07-03","source_url":"https://clinicaltrials.gov/study/NCT03824041","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":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:15:54.38+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"45 Years to 75 Years","comparator":"Placebo","organization":"Colorado State University","interventions":["Aronia full spectrum - half dose","Aronia full spectrum - full dose","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption — Baseline and 6 weeks","Gut microbiota analysis — Baseline and 6 weeks","Blood pressure — Baseline and 6 weeks","Augmentation index — Baseline and 6 weeks","Gastrointestinal health — Baseline and 6 weeks","Pulse wave velocity — Baseline and 6 weeks","Blood lipids — Baseline and 6 weeks","Blood hemoglobin A1c — Baseline and 6 weeks","Blood oxidized LDL — Baseline and 6 weeks","Blood ICAM — Baseline and 6 weeks","Blood VCAM — Baseline and 6 weeks"],"design_description":"RANDOMIZED · CROSSOVER · BASIC SCIENCE · DOUBLE","source_has_results":false},"controlled_terms":["Endothelial Dysfunction","Aging","Aronia full spectrum - half dose","Aronia full spectrum - full dose","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:16:07.48358+00:00","duplicate_cluster_key":"id:nct03824041","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-02-11 to 2021-07-26","comparator":"Placebo","confidence":"structured-source","population":"ALL · 45 Years to 75 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":"2026-09-25T06:15:54.460Z","intervention":["Aronia full spectrum - half dose","Aronia full spectrum - full dose","Placebo"],"participants":24,"study_design":"RANDOMIZED · CROSSOVER · BASIC SCIENCE · DOUBLE","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":["Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption — Baseline and 6 weeks","Gut microbiota analysis — Baseline and 6 weeks","Blood pressure — Baseline and 6 weeks","Augmentation index — Baseline and 6 weeks","Gastrointestinal health — Baseline and 6 weeks","Pulse wave velocity — Baseline and 6 weeks","Blood lipids — Baseline and 6 weeks","Blood hemoglobin A1c — Baseline and 6 weeks","Blood oxidized LDL — Baseline and 6 weeks","Blood ICAM — Baseline and 6 weeks","Blood VCAM — Baseline and 6 weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"microbiome-dysbiosis","is_published":true,"match_reasons":["Title contains controlled term: gut microbiota.","Abstract contains controlled term: gut microbiota.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Microbiome and dysbiosis","slug":"microbiome-dysbiosis"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33878","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}