[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220122":3,"trial-entities:NCT07220122":100,"trial-summary:NCT07220122":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":69,"locations":71,"central_contacts":89,"overall_officials":94,"references":98,"see_also_links":99},"NCT07220122","IRB00517978-2","Impact of Exogenous Ketones on Breathing in Healthy Volunteers","Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers","RECRUITING","2027-02-10","2026-03","2026-03-31","2026-03-12","Johns Hopkins University","OTHER",false,"Exogenous ketones (EK) are compounds that can increase the level of ketones in the body without needing to change what an individual eats.\n\nAlthough EK have been researched mainly in relation to energy and exercise, there haven't been many studies focusing specifically on how EKs affect breathing using well-established scientific methods. The investigators believe that EK may help improve breathing, which could be beneficial for situations like high altitudes, sleep apnea, and exercise.\n\nTo explore how EK might influence breathing, the investigators are conducting a randomized, placebo-controlled crossover study with healthy volunteers.","Healthy volunteers will undergo daytime hypercapnic ventilatory response (HCVR) testing before and after ingesting 40g of exogenous ketones or placebo. Circulating ketone levels (beta-hydroxybutyrate) will be measured at baseline, 1 hour, and 2.5 hours after ingestion (immediately before HCVR testing). Studies will require two visits with a minimum of 48 hr. (and up to a max of 14 days) of washout.\n\nThe specific ketone product to be tested is 1,3 butanediol (1,3BD) in a commercially available formulation called \"Ketone IQ\". A taste-matched placebo will also be supplied by the sponsor. 1,3BD is converted by liver metabolism into the ketone body beta-hydroxybutyrate (BHB) and has been utilized in multiple studies.\n\nPROCEDURES:\n\nThis is a randomized, single-blind, crossover study. Each participant will complete two testing sessions with a minimum of 48-hour washout period between visits. The single-blind design enables research staff to measure BHB levels and assess pharmacokinetic timing for potential adjustments to procedure timing, while keeping participants blinded to the intervention.\n\nBaseline visit: A medical history and physical examination will be performed. A urine pregnancy screening test will be conducted for women under 60 years of age. A \"run-in\" procedure will be performed to confirm that participants can tolerate the taste of the ketone supplement. Participants will then be randomized to one of two arms:\n\n* Group A: Visit 1 Ketones, Visit 2 Placebo\n* Group B: Visit 1 Placebo, Visit 2 Ketones\n\nSession 1:\n\nHCVR Procedure: Participants will wear a facemask connected to a breathing circuit with a three-way stopcock, allowing inhaled gas to be switched from ambient air to a pre-mixed gas source. A one-way valve will divert exhaled gas to prevent rebreathing. The participant will breathe room air for 3-5 minutes to collect baseline ventilation data. The investigators will then switch to a non-diffusing gas bag containing 7% Carbon Dioxide (CO₂) \u002F 93% O₂ and the participant will breathing this hypercapnic gas until end-tidal CO₂ (ETCO₂) reaches a stable plateau and is maintained (up to 3 minutes, as tolerated).\n\nExhaled CO₂ and airflow will be continuously monitored using a pneumotachograph to derive tidal volume and respiratory rate. The HCVR slope will be calculated as minute ventilation (L\u002Fmin) plotted against end-tidal CO₂ (mmHg).\n\nSession Sequence:\n\n1. Participants will arrive at the lab after an overnight fast.\n2. Baseline HCVR testing will be conducted before study product ingestion.\n3. Participants will ingest 40 g Ketone-IQ or placebo.\n4. Repeat HCVR testing 2.5 hours post-ingestion.\n\nCapillary BHB levels will be measured at baseline, 1 hour, and 2.5 hours post-ingestion of Ketone-IQ. Participants will not see the BHB levels (so that the placebo condition will be appropriately masked).\n\nSession 2:\n\nThis session will mirror Session 1, with participants crossing over to the alternate condition (i.e., Ketone-IQ or placebo), following a minimum 48-hour washout period.",[19],"Healthy Volunteer",[21],"ketones breathing exogenous","INTERVENTIONAL","BASIC_SCIENCE",[25],"EARLY_PHASE1",{"count":27,"type":28},20,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIETARY_SUPPLEMENT","1,3 butanediol","40 mg Ketone-IQ beverage",[35,36],"Ketones first","Placebo first",{"type":31,"name":38,"description":39,"armGroupLabels":40},"Placebo","Placebo (taste matched)",[35,36],[42],{"measure":43,"description":44,"timeFrame":45},"Hypercapnic Ventilatory Response (HCVR)","Minute ventilation (L\u002Fmin) while breathing 7% Carbon Dioxide (CO2). Measured once during each visit.","During each visit, one measurement at baseline, repeated again 2.5 hours after ingesting Ketone-IQ or Placebo",[47],{"measure":48,"description":49,"timeFrame":50},"Ketone Level","Beta-hydroxybutyrate (BHB) in millimole (mmol) from blood. Measured 4 times during each visit.","During each visit measured 4 times (baseline, 1 hour, 2.5 hours post-ingestion)","ALL","18 Years","50 Years",true,{"inclusion":56,"exclusion":58,"raw_text":68},[57],"BMI of 18 - 30 kg\u002Fm2",[59,60,61,62,63,64,65,66,67],"No concomitant sleep disorder (e.g. sleep apnea, insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia). If there is no known diagnosis of sleep apnea, a STOP-BANG score of 5 or higher is an exclusion.","No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled Chronic Obstructive Pulmonary Disease (COPD), pneumonia, interstitial lung disease.","No known history of chronic renal disease or diabetes (type 1 or type 2).","No use of supplemental oxygen.","Cannot be on a low carbohydrate (\\\u003C130 g carbohydrate\u002Fday) or ketogenic diet, intermittent fasting, or consuming exogenous ketones","Cannot be pregnancy or breastfeeding","Cannot be on medications: acetazolamide or Sodium-glucose cotransporter-2 (SGLT2) inhibitor, daily opioid use.","No history of claustrophobia or panic disorder","No frequent alcohol intake (more than 1 drink per day on average, or \\> 10 drinks per week).","Inclusion Criteria:\n\n* BMI of 18 - 30 kg\u002Fm2\n\nExclusion Criteria:\n\n* No concomitant sleep disorder (e.g. sleep apnea, insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia). If there is no known diagnosis of sleep apnea, a STOP-BANG score of 5 or higher is an exclusion.\n* No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled Chronic Obstructive Pulmonary Disease (COPD), pneumonia, interstitial lung disease.\n* No known history of chronic renal disease or diabetes (type 1 or type 2).\n* No use of supplemental oxygen.\n* Cannot be on a low carbohydrate (\\\u003C130 g carbohydrate\u002Fday) or ketogenic diet, intermittent fasting, or consuming exogenous ketones\n* Cannot be pregnancy or breastfeeding\n* Cannot be on medications: acetazolamide or Sodium-glucose cotransporter-2 (SGLT2) inhibitor, daily opioid use.\n* No history of claustrophobia or panic disorder\n* No frequent alcohol intake (more than 1 drink per day on average, or \\> 10 drinks per week).",[70],"ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":86},"Johns Hopkins Bayview Medical Center","Baltimore","Maryland","21224","United States",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":83,"email":83},"Jonathan C Jun","CONTACT","410-550-0115","jjun2@jhmi.edu",{"name":85,"role":81,"email":83},"MD",{"lat":87,"lon":88},39.29038,-76.61219,[90],{"name":91,"role":81,"phone":92,"email":93},"Mariah Potocki","410-550-2233","mchaney7@jhmi.edu",[95],{"name":96,"affiliation":13,"role":97},"Jonathan C Jun, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[19],[],{"nct_id":4,"found":54,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is a randomized, single-blind, crossover study involving 20 healthy volunteers. Participants will receive either Ketone-IQ or a placebo in two separate visits.","completed","Impact of Ketone-IQ on Breathing in Healthy Volunteers","This study is looking at how a dietary supplement called Ketone-IQ (1,3 butanediol) affects breathing in healthy adults. Researchers want to see if this supplement, which increases ketone levels in the body, can improve how people breathe. While exogenous ketones (ketones from outside the body) have been studied for energy and exercise, their effect on breathing hasn't been fully explored. This study aims to measure changes in your breathing response (Hypercapnic Ventilatory Response, or HCVR) after you drink Ketone-IQ or a taste-matched placebo. You can join if you are a healthy volunteer between 18 and 50 years old with a BMI between 18 and 30. The study is currently recruiting 20 participants.","Your breathing will be measured at baseline and again 2.5 hours after ingesting the study drink during each visit.",112,"You will have two visits, at least 48 hours apart. Each visit involves a medical history, physical exam, a taste test, and breathing measurements before and after drinking the supplement or placebo.","Not stated in the trial record.",[32,38],"v2"]