[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06115148":3,"trial-entities:NCT06115148":84,"trial-summary:NCT06115148":87},{"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":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":41,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":73,"overall_officials":78,"references":82,"see_also_links":83},"NCT06115148","PBRC 2022-059","Breath Analysis & Malnutrition","Breath Ammonia as a Malnutrition Screening Tool","RECRUITING","2026-12-30","2025-12","2026-01-21","2023-08-17","Pennington Biomedical Research Center","OTHER",false,"The purpose of this research study is to understand how breath is related to nutritional status. The procedures involved in this study include blood and breath sampling, questionnaires about health history, medications, nutritional status and diet, and a physical examination. Breath markers will be compared between individuals with and without malnutrition and be compared to indicators of malnutrition. Some individuals will undergo an interventional study involving 2 days of consuming study beverages and fasting along with providing additional breath samples to see if the breath changes in response to short-term changes in nutritional status.","Research Summary: This research involves a cross-sectional study investigating whether breath molecules (in particular ammonia and nitric oxide) are related to the presence and magnitude of malnutrition as measured by the gold-standard nutrition focused physical examination (NFPE). It also involves an interventional study in a subset of cross-sectional participants looking at whether acute changes in nutritional status through anabolic feeding protocols or fasting protocols is related to short term changes in breath molecules.\n\nPurpose of the Research: The purpose is to identify early evidence of breath biomarkers of malnutrition. It uses a combination of breath analysis and current malnutrition screening tools (questionnaires).",[19],"Malnutrition",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},12,"ESTIMATED",[28,32],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Feeding","Nutrition beverages will be provided to meet the nutrient needs described in the Feeding Arm.",[29],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Fasting","Water will be consumed as described during the Fasting Arm.",[33],[37],{"measure":38,"description":39,"timeFrame":40},"Breath Ammonia","Breath ammonia (ppm)","Interventional: Upon waking and after the intervention, but before bed on each of the 1-day intervention arms",[42,45],{"measure":43,"description":44,"timeFrame":40},"Breath volatile organic compounds","Untargeted mass spectrometry on breath volatile organic compound concentration in breath",{"measure":46,"description":47,"timeFrame":40},"Fractional Exhaled Nitric Oxide","Fractional exhaled nitric oxide (ppb)","ALL","18 Years","95 Years",true,{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion Criteria:\n\n1. Age: 18-95 years\n2. Malnutrition group (Cross-sectional study only); not involved in intervention: Diagnosed with malnutrition (verified in medical history)\n\nExclusion Criteria:\n\n1. Chronic kidney, liver or pulmonary disease\n2. Anabolic steroid use other than testosterone (e.g., oxandrolone)\n3. Patients judged unsuitable for enrollment by the study medical investigator\n4. Pregnant women or women who are nursing\n5. Unable or unwilling to consume study beverages or fast for 24 hours each arm",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":13,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":70},"Baton Rouge","Louisiana","70808","United States",[66],{"role":67,"phone":68,"email":69},"CONTACT","225-763-3000","clinicaltrials@pbrc.edu",{"lat":71,"lon":72},30.44332,-91.18747,[74],{"name":75,"role":67,"phone":76,"email":77},"Jacob T Mey, PhD, RD","225-763-2644","jacob.mey@pbrc.edu",[79],{"name":80,"affiliation":13,"role":81},"Jacob Mey, PhD, RD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":86},[19],[],{"nct_id":4,"found":51,"summary":88,"prompt_version":98},{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an interventional study, meaning some participants will receive specific interventions like nutrition beverages or fasting. It also includes a cross-sectional part comparing people with and without malnutrition.","completed","Breath Analysis and Malnutrition Study","This research study is looking at how your breath might be connected to your nutritional health. We want to see if specific molecules in your breath, like ammonia, change when you have malnutrition. We'll compare breath samples from people with and without malnutrition, and also look at how breath changes after short periods of eating special nutrition drinks or fasting (not eating, only drinking water). If you join, you'll provide blood and breath samples, answer questions about your health and diet, and have a physical exam. This study aims to find early signs of malnutrition using breath analysis. We are looking for 12 participants aged 18 to 95 years old who have been diagnosed with malnutrition. The study status is currently unclear.","Breath ammonia will be measured upon waking and after the intervention, but before bed on each of the 1-day intervention arms.",122,"You will provide blood and breath samples, answer questionnaires about your health, medications, nutritional status, and diet, and have a physical examination. Some participants will also consume study beverages or fast for two days and provide additional breath samples.","Not stated in the trial record.",[33],"v2"]