{"type":"trials","record":{"id":32545,"source_id":"clinicaltrials-gov","external_id":"NCT03679533","title":"The Impact of Cranberries On the Microbiome and the Brain in Healthy Ageing sTudy (COMBAT)","brief_summary":"Tremendous progress has been made in characterizing the interactions between the central nervous system and the gastrointestinal tract. This concept of a gut-brain axis suggests that influencing bacteria in the gut is a promising approach for developing new ways of benefiting brain function. This is particularly relevant for an ageing population for which cognitive decline is a common symptom and can be an indicator for the development of neurodegenerative conditions such as dementia. There is good evidence already that nutrition can delay the development of cognitive decline in ageing, in particular for ageing-sensitive brain regions such as the medial temporal lobe, however this has been little explored for cranberry intake. Cranberries are high in plant-derived nutrients called polyphenols, which have been suggested to promote brain function and protect against disease-causing mechanisms. In the proposed project we will pioneer work to investigate the impact of cranberry intake on gut bacteria and how it relates to cognitive performance in ageing and associated regions in the brain. This study is being conducted by Chief Investigators Dr David Vauzour and Prof Michael Hornberger at the University of East Anglia. Sixty participants (i.e. n=30 control and treatment groups) aged 50-80 years old, with no memory complaints will be recruited for this 12-week double-blind placebo-controlled parallel intervention of cranberry flavonoids. Freeze-dried cranberry or a matched placebo will be taken twice daily for the duration of the trial. Blood, urine and faecal samples will be collected for microbiome, DNA, biochemical and nutritional analysis. Participants will also undergo cognitive testing, as well as MRI scanning to detect changes in brain physiology.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of East Anglia","enrollment":60,"countries":["United Kingdom"],"start_date":"2018-10-02","completion_date":"2020-05-22","last_update_date":"2020-09-30","source_url":"https://clinicaltrials.gov/study/NCT03679533","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":"2026-09-25T01:20:02.68364+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"ALL","acronym":"COMBAT","age_range":"50 Years to 80 Years","comparator":"Active Cranberry Study Food; Placebo Study Food","organization":"University of East Anglia","interventions":["Freeze-Dried Cranberry Powder","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Gut microflora speciation and metabolism — 12 weeks","Change in volumes of hippocampus and other key brain structures — 12 weeks","Change in cerebrovascular blood flow — 12 weeks","Change in global cognition — 12 weeks","Change in spatial navigation abilities — 12 weeks","Change in executive function and attention — 12 weeks","Change in memory performance — 12 weeks","Change in executive function and attention — 12 Weeks","Change in presence of circulating inflammatory biomarkers (hs-CRP) — 12 weeks","Change in circulating biomarkers of neuronal functioning and cognitive decline (BDNF) — 12 weeks","Change in circulating biomarkers of lipid metabolism (total-, HDL-, LDL-cholesterol) — 12 weeks","Change in circulating biomarkers of lipid metabolism (triglycerides) — 12 weeks","Changes in energy expenditure and sleep — 12 weeks","Genetics related to neurodegenerative disease — Baseline","Biomarkers of gut permability and endotoxemia (LPS) — 12 weeks","Levels of sunlight exposure — Baseline, Follow-up"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","source_has_results":false},"controlled_terms":["Aging","Cognitive Decline","Freeze-Dried Cranberry Powder","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: microbiome.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct03679533","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-10-02 to 2020-05-22","comparator":"Active Cranberry Study Food; Placebo Study Food","confidence":"structured-source","population":"ALL · 50 Years to 80 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":"2026-09-25T06:05:41.163Z","intervention":["Freeze-Dried Cranberry Powder","Placebo"],"participants":60,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · QUADRUPLE","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":["Gut microflora speciation and metabolism — 12 weeks","Change in volumes of hippocampus and other key brain structures — 12 weeks","Change in cerebrovascular blood flow — 12 weeks","Change in global cognition — 12 weeks","Change in spatial navigation abilities — 12 weeks","Change in executive function and attention — 12 weeks","Change in memory performance — 12 weeks","Change in executive function and attention — 12 Weeks","Change in presence of circulating inflammatory biomarkers (hs-CRP) — 12 weeks","Change in circulating biomarkers of neuronal functioning and cognitive decline (BDNF) — 12 weeks","Change in circulating biomarkers of lipid metabolism (total-, HDL-, LDL-cholesterol) — 12 weeks","Change in circulating biomarkers of lipid metabolism (triglycerides) — 12 weeks","Changes in energy expenditure and sleep — 12 weeks","Genetics related to neurodegenerative disease — Baseline","Biomarkers of gut permability and endotoxemia (LPS) — 12 weeks","Levels of sunlight exposure — Baseline, Follow-up"],"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: microbiome.","Abstract contains controlled term: microbiome.","Title supplies longevity context: ageing.","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/32545","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}