{"type":"trials","record":{"id":29150,"source_id":"clinicaltrials-gov","external_id":"NCT05400005","title":"Impact of Different Types of Higher Dietary Protein Intake on Sleep Quality in Singapore Older Adults","brief_summary":"Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. More importantly, due to COVID-19 health emergency, there is a significant increase of psychological distress and symptoms of mental illness and a worsening of quality of sleep. Therefore, there is an urgent need to investigate the way of improving sleep quality, in particular during and post COVID-19 period, in older adults. One of the possible strategies in improving sleep quality with lifestyle modification is having higher-protein diet. However, this effect has not been fully elucidated in older adults. In addition, the effect of type of dietary protein on sleep quality is inconclusive and there is no clinical trial which assessed the differential response in sleep quality between animal-sourced protein vs. plant-sourced protein. Therefore, the purpose of this research project is to assess the impact of different types of higher dietary protein intake on sleep quality in Singapore older adults. Findings from the proposed research will provide the scientific evidence of the beneficial effects of regularly consuming higher-protein diet on sleep quality in Singapore older adults. In addition, this research may validate the differential effect of different type of dietary protein on sleep quality. The results from the proposed research will also assist a practical guidance of nutritional behaviour changes providing sleep promoting effects to a large proportion of the Singapore population.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"National University of Singapore","enrollment":54,"countries":["Singapore"],"start_date":"2023-02-01","completion_date":"2025-12-01","last_update_date":"2025-09-10","source_url":"https://clinicaltrials.gov/study/NCT05400005","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not 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":"60 Years to 85 Years","comparator":"Normal protein diet (control)","organization":"National University of Singapore","interventions":["Dietary protein"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in sleep quality assessed by validated sleep questionnaires — Every 4 weeks (week 0, week 4, week 8, week 12 and…","Change in sleep quality assessed by electronic equipment — Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)","Change in blood amino acid concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in blood serotonin concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in urinary 6-sulfatoxymelatonin (aMT6s) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal microbiome composition — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal short chain fatty acid (SCFA) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in serum lipopolysaccharide binding protein (LBP) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in blood short chain fatty acid (SCFA) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal bile acids — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal zonulin — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal calprotectin — Every 8 weeks (week 0 , week 8 and week 16)","Change in urinary creatinine concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in Estimated Glomerular Filtration Rate (eGFR) — Every 8 weeks (week 0 , week 8 and week 16)","Change in Trimethylamine N-oxide (TMAO) — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Glucose — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Triglyceride — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Cholesterol — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Low-density Lipoprotein-cholesterol (LDL) — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood High-density Lipoprotein-cholesterol (LDL) — Every 8 weeks (week 0 , week 8 and week 16)"],"design_description":"RANDOMIZED · FACTORIAL · BASIC SCIENCE · DOUBLE","source_has_results":false},"controlled_terms":["Sleep","Gut Microbiome","Cardiometabolic Risk","Dietary protein"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: sleep.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct05400005","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-02-01 to 2025-12-01","comparator":"Normal protein diet (control)","confidence":"structured-source","population":"ALL · 60 Years to 85 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":"2026-09-25T06:05:41.138Z","intervention":["Dietary protein"],"participants":54,"study_design":"RANDOMIZED · FACTORIAL · BASIC SCIENCE · 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":["Change in sleep quality assessed by validated sleep questionnaires — Every 4 weeks (week 0, week 4, week 8, week 12 and…","Change in sleep quality assessed by electronic equipment — Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)","Change in blood amino acid concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in blood serotonin concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in urinary 6-sulfatoxymelatonin (aMT6s) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal microbiome composition — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal short chain fatty acid (SCFA) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in serum lipopolysaccharide binding protein (LBP) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in blood short chain fatty acid (SCFA) concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal bile acids — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal zonulin — Every 8 weeks (week 0 , week 8 and week 16)","Change in fecal calprotectin — Every 8 weeks (week 0 , week 8 and week 16)","Change in urinary creatinine concentration — Every 8 weeks (week 0 , week 8 and week 16)","Change in Estimated Glomerular Filtration Rate (eGFR) — Every 8 weeks (week 0 , week 8 and week 16)","Change in Trimethylamine N-oxide (TMAO) — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Glucose — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Triglyceride — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Cholesterol — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood Low-density Lipoprotein-cholesterol (LDL) — Every 8 weeks (week 0 , week 8 and week 16)","Change in Blood High-density Lipoprotein-cholesterol (LDL) — Every 8 weeks (week 0 , week 8 and week 16)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sleep","is_published":true,"match_reasons":["Title contains controlled term: sleep.","Abstract contains controlled term: sleep.","Source terminology contains: sleep.","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":"Sleep","slug":"sleep"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/29150","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}