{"type":"trials","record":{"id":33940,"source_id":"clinicaltrials-gov","external_id":"NCT02384174","title":"Resistant Starch and Non-starch Polysaccharide (Dietary Fibre) Intake and the Colonic Microbiome in Older People","brief_summary":"The development of preventative nutritional strategies to promote healthy ageing is becoming increasingly important. Elevated thresholds for taste and smell, coupled with swallowing difficulties and masticatory dysfunction, often result in nutritionally imbalanced diets among the elderly. This can induce great changes in the composition and metabolic activities of the gut microbiome, leading to decreased intestinal motility and impaired bowel function. This can result in constipation or diarrhoea, increased basal levels of inflammation, immunosenescence and morbidity. The objectives of this study are to use dietary modification to improve gut health in older people. Diets high in resistant starch or dietary fibre will be given to 50 elderly volunteers (70-95 years) living in the community, in a randomised double-blind cross-over study. The aim is to investigate the effects on microbiome composition and functionality through fermentation, reduced putrefaction, and modification of blood markers associated with obesity and diabetes.","overall_status":"Withdrawn","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Dundee","enrollment":0,"countries":["United Kingdom"],"start_date":"2015-05-01","completion_date":"2017-02-01","last_update_date":"2020-07-27","source_url":"https://clinicaltrials.gov/study/NCT02384174","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Withdrawn. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.953004+00:00","last_seen_at":"2026-09-25T06:15:06.064+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"70 Years to 95 Years","comparator":null,"organization":"University of Dundee","interventions":["Resistant starch","Dietary fibre (arabinogalactan, gum guar, pectin)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybr…","Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.…","Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked im…","Number of participants with change in faecal genotoxic potential determined by measurement of faecal bacterial enzymes…","Number of participants with a change in bowel habit and quality of life measured by completion of a bowel habit diary a…"],"design_description":"RANDOMIZED · CROSSOVER · PREVENTION · QUADRUPLE","source_has_results":false},"controlled_terms":["Aging","Resistant starch","Dietary fibre (arabinogalactan, gum guar, pectin)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: microbiome.","quality_checked_at":"2026-09-25T06:15:09.632521+00:00","duplicate_cluster_key":"id:nct02384174","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2015-05-01 to 2017-02-01","comparator":null,"confidence":"structured-source","population":"ALL · 70 Years to 95 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":"2026-09-25T06:15:06.091Z","intervention":["Resistant starch","Dietary fibre (arabinogalactan, gum guar, pectin)"],"participants":0,"study_design":"RANDOMIZED · CROSSOVER · 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":["Number of participants with change in levels of faecal bifidobacteria measured by quantitative fluorescent in situ hybr…","Number of participants with change in the bacterial composition of the faecal microbiome measured by quantitative FISH.…","Number of participants with change in inflammatory markers linked to ageing measured in whole blood by enzyme linked im…","Number of participants with change in faecal genotoxic potential determined by measurement of faecal bacterial enzymes…","Number of participants with a change in bowel habit and quality of life measured by completion of a bowel habit diary a…"],"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: older people.","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/33940","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}