{"type":"trials","record":{"id":33571,"source_id":"clinicaltrials-gov","external_id":"NCT02968992","title":"Effects of rhLactoferrin on Chronic Inflammation in the Elderly","brief_summary":"The purpose of this study is to investigate how recombinant human lactoferrin (rhLF) which is a partially iron saturated form of lactoferrin produced and purified from rice grain may improve mobility and memory in older adults with chronic inflammation. Lactoferrin, is a known multifunctional protein, and has been shown to have anti-inflammatory effects. A recombinant human version of this protein was recently developed and produced from rice. This is now available from the Ventria Bioscience Company in a controlled, pharmaceutical grade capsule. As part of this double blinded and randomized study, participants will take daily dosages of recombinant human lactoferrin (rhLF) or its matched placebo; to measure the effects of rhlactoferrin on chronic inflammation and its association with improving mobility and memory over a 6 month time period. During the study all participants will be asked to provide blood samples and will have physical and cognitive tests administered to them. By measuring biomarkers in the blood as well as changes in physical and cognitive measures, the investigators will gain an understanding of how rhlactoferrin may safely improve measures of chronic inflammation in older adults. As well as a better understanding of whether it has the potential to meaningfully influence important measures of physical and cognitive function known to be influenced by Chronic Inflammation (CI).","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Johns Hopkins University","enrollment":36,"countries":["United States"],"start_date":"2017-08-14","completion_date":"2019-02-25","last_update_date":"2023-10-03","source_url":"https://clinicaltrials.gov/study/NCT02968992","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.10691+00:00","last_seen_at":"2026-09-25T06:05:37.656+00:00","metadata":{"sex":"ALL","acronym":"ELCIE","age_range":"70 Years","comparator":"Placebo","organization":"Johns Hopkins University","interventions":["rhLactoferrin","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) — Baseline and 6 months","The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1) — From baseline to 6 mont…","Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test — At 6 months","Attenuating Cognitive Decline as Measured by the Trail Making Test A and B. — At 6 months","Physical Mobility as Measured by 4 Meter Walk Test — At 6 months","Physical Mobility as Measured by 6 Minute Walk Test — At 6 months","Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects — From baseline through…","Physical Strength as Measured by Grip Strength — At 6 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":true},"controlled_terms":["Inflammation","Cognitive Deterioration","rhLactoferrin","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: chronic inflammation.","quality_checked_at":"2026-09-25T06:05:39.423355+00:00","duplicate_cluster_key":"id:nct02968992","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2017-08-14 to 2019-02-25","comparator":"Placebo","confidence":"structured-source","population":"ALL · 70 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":"2026-09-25T06:05:37.669Z","intervention":["rhLactoferrin","Placebo"],"participants":36,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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":["The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6) — Baseline and 6 months","The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1) — From baseline to 6 mont…","Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test — At 6 months","Attenuating Cognitive Decline as Measured by the Trail Making Test A and B. — At 6 months","Physical Mobility as Measured by 4 Meter Walk Test — At 6 months","Physical Mobility as Measured by 6 Minute Walk Test — At 6 months","Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects — From baseline through…","Physical Strength as Measured by Grip Strength — At 6 months"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"chronic-inflammation","is_published":true,"match_reasons":["Title contains controlled term: chronic inflammation.","Abstract contains controlled term: chronic inflammation.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Chronic inflammation","slug":"chronic-inflammation"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33571","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}