{"type":"trials","record":{"id":29045,"source_id":"clinicaltrials-gov","external_id":"NCT07592975","title":"Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults (GutFood)","brief_summary":"Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes. Nutritional inadequacies, including low dietary fibre intake and suboptimal B-vitamin status, are common in older adults and may contribute to these age-related health issues. Research suggests that increasing dietary fibre intake, particularly through prebiotics such as inulin, may help to improve gut health. In addition, B-vitamins have been linked to both gut and mental health, although their combined effects with prebiotics are not well understood. With the assistance of a food company, the investigators have developed a functional drink enriched with chicory inulin, alone or in combination with B-vitamins. Therefore, the investigators plan to conduct a 12-week randomised, double-blind, placebo-controlled trial to test the effect of this functional drink on gut health outcomes, nutritional status, inflammation, and mental health in adults aged 50 years and older.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Ulster","enrollment":84,"countries":["United Kingdom"],"start_date":"2026-05-18","completion_date":"2026-12-01","last_update_date":"2026-05-18","source_url":"https://clinicaltrials.gov/study/NCT07592975","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:08.862442+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"50 Years","comparator":"Inulin and B-vitamins; Inulin only; Placebo","organization":"University of Ulster","interventions":["Inulin and B-vitamins","Inulin","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Gut microbiome profile — 12 weeks","Serum total homocysteine — 12 weeks","Folate — 12 weeks","Vitamin B12 — 12 weeks","Vitamin B6 — 12 weeks","Riboflavin — 12 weeks","Inflammation — 12 weeks","Gut microbial metabolites — 12 weeks","Depressive symptoms — 12 weeks","Anxiety symptoms — 12 weeks","Sleep quality — 12 weeks","Physiological stress — 12 weeks"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · DOUBLE","source_has_results":false},"controlled_terms":["Biomarkers of B-vitamin Status and Gut Microbiome Composition","Inulin and B-vitamins","Inulin","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: gut microbiota.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct07592975","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-05-18 to 2026-12-01","comparator":"Inulin and B-vitamins; Inulin only; Placebo","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":"2026-09-25T06:05:41.123Z","intervention":["Inulin and B-vitamins","Inulin","Placebo"],"participants":84,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · 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":["Gut microbiome profile — 12 weeks","Serum total homocysteine — 12 weeks","Folate — 12 weeks","Vitamin B12 — 12 weeks","Vitamin B6 — 12 weeks","Riboflavin — 12 weeks","Inflammation — 12 weeks","Gut microbial metabolites — 12 weeks","Depressive symptoms — 12 weeks","Anxiety symptoms — 12 weeks","Sleep quality — 12 weeks","Physiological stress — 12 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.","Source terminology contains: microbiome.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","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/29045","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}