{"type":"trials","record":{"id":34381,"source_id":"clinicaltrials-gov","external_id":"NCT05679596","title":"Exogenous Ketosis During Bed Rest in Older Adults","brief_summary":"The goal of this randomized, double-blind, parallel group interventional study is to evaluate the effect of ketone bodies on healthy older adults (65-85 y) during 5 days of bed rest. The main questions it aims to answer are: Does supplementation of ketone bodies prevent the typical decline in muscle protein synthesis, muscle size, muscle function, insulin sensitivity, and muscle mitochondrial function that occurs in response to bed rest? Researchers will compare ketone supplements (KET) to an energy matched control beverage (carbohydrates and fats) to see if the ketones can rescue the decline in muscle protein synthesis rates, muscle loss, muscle function, insulin sensitivity, and mitochondrial function due to 5 days of bed rest. This may positively impact the heath of older adults subjected to bed rest.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"McGill University","enrollment":30,"countries":["Canada"],"start_date":"2023-02-27","completion_date":"2023-11-15","last_update_date":"2024-02-07","source_url":"https://clinicaltrials.gov/study/NCT05679596","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":"2026-09-25T01:20:17.421904+00:00","last_seen_at":"2026-09-25T06:05:56.331+00:00","metadata":{"sex":"ALL","acronym":"KBR","age_range":"65 Years to 85 Years","comparator":"Energy matched control (CON)","organization":"McGill University","interventions":["ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate","carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Changes in integrated fractional synthesis rate (%/d) in response to bed rest with and without ketone monoester (KET) s…","Changes in whole body insulin sensitivity in response to bed rest with and without ketone monoester (KET) supplementati…","Changes in whole-body lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation —…","Changes in leg lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation — Day -3…","Changes in quadriceps muscle volume in response to bed rest with and without ketone monoester (KET) supplementation. —…","Changes in maximal voluntary isometric contraction (N/m) of the knee extensors in response to bed rest with and without…","Changes in handgrip strength (kg) in response to bed rest with and without ketone monoester (KET) supplementation. — Da…","Changes in physical performance (numerical score) as determined by short physical performance battery (SPPB) in respons…","Changes in physical performance (numerical score) as determined by 5-item physical performance test in response to bed…","Changes in cognitive status in response to bed rest with and without ketone monoester (KET) supplementation. — Day 4 an…","Changes in markers of inflammation in systemic circulation in response to bed rest with and without ketone monoester (K…","Changes in muscle mRNA expression of inflammatory regulators will be assessed in response to bed rest with and without…","Changes in skeletal muscle phenotype in response to bed rest with and without ketone monoester (KET) supplementation. —…","Changes in skeletal muscle fiber size in response to bed rest with and without ketone monoester (KET) supplementation.…","Changes in mitochondrial content in response to bed rest with and without ketone monoester (KET) supplementation. — Day…","Changes in mitochondrial respiration in response to bed rest with and without ketone monoester (KET) supplementation. —…","Changes in mitochondrial calcium retention capacity (marker of mitochondrial propensity to trigger apoptosis) in respon…","Changes in mitochondrial reactive oxygen species (ROS) production in response to bed rest with and without ketone monoe…","Changes in mitochondrial time to the permeability transition pore opening (marker of mitochondrial propensity to trigge…","Changes in the phosphorylation status of anabolic signaling molecules modulating muscle protein synthesis (MPS) in resp…"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · TRIPLE","source_has_results":false},"controlled_terms":["Muscle Protein Synthesis","Muscle Atrophy","Insulin Sensitivity","Mitochondrial Function","Physical Inactivity","Cognitive Function","Muscle Strength","Functional Capacity","ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate","carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: ketosis.","quality_checked_at":"2026-09-25T06:05:58.178511+00:00","duplicate_cluster_key":"id:nct05679596","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-02-27 to 2023-11-15","comparator":"Energy matched control (CON)","confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:05:56.348Z","intervention":["ketone monoester (R)-3-hydroxybutyl (R)-3- hydroxybutyrate","carbohydrate-fat placebo (fructose, corn and canola oil 50:50 ratio)"],"participants":30,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · TRIPLE","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":["Changes in integrated fractional synthesis rate (%/d) in response to bed rest with and without ketone monoester (KET) s…","Changes in whole body insulin sensitivity in response to bed rest with and without ketone monoester (KET) supplementati…","Changes in whole-body lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation —…","Changes in leg lean mass (kg) in response to bed rest with and without ketone monoester (KET) supplementation — Day -3…","Changes in quadriceps muscle volume in response to bed rest with and without ketone monoester (KET) supplementation. —…","Changes in maximal voluntary isometric contraction (N/m) of the knee extensors in response to bed rest with and without…","Changes in handgrip strength (kg) in response to bed rest with and without ketone monoester (KET) supplementation. — Da…","Changes in physical performance (numerical score) as determined by short physical performance battery (SPPB) in respons…","Changes in physical performance (numerical score) as determined by 5-item physical performance test in response to bed…","Changes in cognitive status in response to bed rest with and without ketone monoester (KET) supplementation. — Day 4 an…","Changes in markers of inflammation in systemic circulation in response to bed rest with and without ketone monoester (K…","Changes in muscle mRNA expression of inflammatory regulators will be assessed in response to bed rest with and without…","Changes in skeletal muscle phenotype in response to bed rest with and without ketone monoester (KET) supplementation. —…","Changes in skeletal muscle fiber size in response to bed rest with and without ketone monoester (KET) supplementation.…","Changes in mitochondrial content in response to bed rest with and without ketone monoester (KET) supplementation. — Day…","Changes in mitochondrial respiration in response to bed rest with and without ketone monoester (KET) supplementation. —…","Changes in mitochondrial calcium retention capacity (marker of mitochondrial propensity to trigger apoptosis) in respon…","Changes in mitochondrial reactive oxygen species (ROS) production in response to bed rest with and without ketone monoe…","Changes in mitochondrial time to the permeability transition pore opening (marker of mitochondrial propensity to trigge…","Changes in the phosphorylation status of anabolic signaling molecules modulating muscle protein synthesis (MPS) in resp…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"ketogenic-diets","is_published":true,"match_reasons":["Title contains controlled term: ketosis.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Ketogenic diets","slug":"ketogenic-diets"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/34381","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}