{"type":"trials","record":{"id":44461,"source_id":"clinicaltrials-gov","external_id":"NCT05166564","title":"The PROtein Enriched MEDiterranean Diet and EXercise Trial for Older Adults At Risk of Undernutrition","brief_summary":"PROMED-EX is a single-blind, parallel group randomised controlled trial to determine the effect of a PROtein enriched MEDiterranean diet (PROMED) in comparison to a PROtein enriched MEDiterranean diet and EXercise (PROMED-EX) intervention, or standard care on the nutritional status and cognitive performance of older undernourished adults with subjective cognitive decline.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Queen's University, Belfast","enrollment":105,"countries":["United Kingdom"],"start_date":"2022-01-18","completion_date":"2025-01-31","last_update_date":"2025-03-27","source_url":"https://clinicaltrials.gov/study/NCT05166564","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":"2026-09-25T01:30:10.405111+00:00","last_seen_at":"2026-09-25T07:05:20.248+00:00","metadata":{"sex":"ALL","acronym":"PROMED-EX","age_range":"60 Years","comparator":"Control group","organization":"Queen's University, Belfast","interventions":["A Protein Enriched Mediterranean Diet (PROMED) Intervention","A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mini Nutritional Assessment Score- Long Form — Baseline and 6 months","Mini Nutritional Assessment Score (midpoint change) — Baseline and 3 months","Nutrient intake: PROMED Mediterranean Diet Score — Baseline, 3 months and 6 months","Nutrient intake: (4 day food diary) — Baseline, 3 months and 6 months","Simplified Nutrition Appetite Questionnaire (SNAQ) — Baseline, 3 months and 6 months","Body Water (%) — Baseline, 3 months and 6 months","Total Body Fat (%) — Baseline, 3 months and 6 months","Lean Muscle Mass (kg) — Baseline, 3 months and 6 months","Weight (kg) and height (cm) — Baseline, 3 months and 6 months","Waist circumference (cm) — Baseline, 3 months and 6 months","Physical Activity determined by completion of a Recent Physical Activity Questionnaire — Baseline, 3 months and 6 months","Capturing Changes in Cognition (Catch-Cog) — Baseline, 3 months and 6 months","Trail Making Tests (TMT) (Part A & B) — Baseline, 3 months and 6 months","Delayed recall test (0-10) — Baseline, 3 months and 6 months","Functional performance measured using the Short Physical Performance Battery (SPPB) test. — Baseline, 3 months and 6 mo…","Grip Strength measured by isometric grip force (0-100kg) — Baseline, 3 months and 6 months","Health-related quality of life (Short Form (SF)-36) — Baseline, 3 months and 6 months","Geriatric Depression Scale — Baseline, 3 months and 6 months","Systolic Blood Pressure (mmHg) — Baseline, 3 months and 6 months","Diastolic Blood Pressure (mmHg) — Baseline, 3 months and 6 months"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","source_has_results":false},"controlled_terms":["Cognitive Impairment","Poor Nutrition","Cognitive Decline","A Protein Enriched Mediterranean Diet (PROMED) Intervention","A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: mediterranean diet.","quality_checked_at":"2026-09-25T07:05:30.295959+00:00","duplicate_cluster_key":"id:nct05166564","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-01-18 to 2025-01-31","comparator":"Control group","confidence":"structured-source","population":"ALL · 60 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":"2026-09-25T07:05:20.305Z","intervention":["A Protein Enriched Mediterranean Diet (PROMED) Intervention","A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention"],"participants":105,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · 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":["Mini Nutritional Assessment Score- Long Form — Baseline and 6 months","Mini Nutritional Assessment Score (midpoint change) — Baseline and 3 months","Nutrient intake: PROMED Mediterranean Diet Score — Baseline, 3 months and 6 months","Nutrient intake: (4 day food diary) — Baseline, 3 months and 6 months","Simplified Nutrition Appetite Questionnaire (SNAQ) — Baseline, 3 months and 6 months","Body Water (%) — Baseline, 3 months and 6 months","Total Body Fat (%) — Baseline, 3 months and 6 months","Lean Muscle Mass (kg) — Baseline, 3 months and 6 months","Weight (kg) and height (cm) — Baseline, 3 months and 6 months","Waist circumference (cm) — Baseline, 3 months and 6 months","Physical Activity determined by completion of a Recent Physical Activity Questionnaire — Baseline, 3 months and 6 months","Capturing Changes in Cognition (Catch-Cog) — Baseline, 3 months and 6 months","Trail Making Tests (TMT) (Part A & B) — Baseline, 3 months and 6 months","Delayed recall test (0-10) — Baseline, 3 months and 6 months","Functional performance measured using the Short Physical Performance Battery (SPPB) test. — Baseline, 3 months and 6 mo…","Grip Strength measured by isometric grip force (0-100kg) — Baseline, 3 months and 6 months","Health-related quality of life (Short Form (SF)-36) — Baseline, 3 months and 6 months","Geriatric Depression Scale — Baseline, 3 months and 6 months","Systolic Blood Pressure (mmHg) — Baseline, 3 months and 6 months","Diastolic Blood Pressure (mmHg) — Baseline, 3 months and 6 months"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"mediterranean-diet","is_published":true,"match_reasons":["Title contains controlled term: mediterranean diet.","Abstract contains controlled term: mediterranean diet.","Source terminology contains: mediterranean diet.","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":"Mediterranean diet","slug":"mediterranean-diet"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/44461","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}