[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06701604":3,"trial-entities:NCT06701604":96,"trial-summary:NCT06701604":100},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":73,"locations":75,"central_contacts":91,"overall_officials":93,"references":94,"see_also_links":95},"NCT06701604","PCTB202104D","Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding","Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation","NOT_YET_RECRUITING","2026-01-15","2024-11","2024-11-22","2024-12-02","The Archer-Daniels-Midland Company","INDUSTRY",false,"The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.","The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.",[19,20],"Amino Acid Absorption","Probiotic",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},30,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIETARY_SUPPLEMENT","Single Strain Probiotic + Milk Protein","• Both conditions matched flavor, color, and serving size",[35],"Milk Protein + Probiotic",{"type":31,"name":37,"description":33,"armGroupLabels":38},"Placebo + Milk Protein",[39],"Milk Protein + Placebo",[41,45],{"measure":42,"description":43,"timeFrame":44},"Rate of amino acid absorption","To determine if the addition of a probiotic to milk protein ingestion changes the rate (in minutes) to which amino acids are absorbed into our bloodstream.","Day 0, Day 22, Day 65",{"measure":46,"description":47,"timeFrame":44},"Concentration of amino acid absorption","To determine if the addition of a probiotic to milk protein ingestion changes the extent (concentration in millimoles\u002FLiter) to which amino acids are absorbed into our bloodstream.",[49,52],{"measure":50,"description":51,"timeFrame":44},"Comprehensive metabolic panel","Comprehensive metabolic panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data.\n\n• All measures are assessed by blood or serum assay analysis",{"measure":53,"description":54,"timeFrame":44},"Blood CBC panel","Blood CBC panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data.\n\n• All measures are assessed by blood or serum assay analysis","ALL","18 Years","35 Years",true,{"inclusion":60,"exclusion":67,"raw_text":72},[61,62,63,64,65,66],"Participants will be male or female between the ages of 18-35 years;","Participants have not been consuming any nutritional supplements for the preceding 6-week period;","Participants have not been consuming any ergogenic aids for the preceding 6-week period;","Participant has provided written and dated informed consent to participate in the study;","Participant is willing and able to comply with the protocol;","Participant is apparently healthy and free from disease, as determined by a health history questionnaire;",[68,69,70,71],"Participant is allergic to any ingredient in the nutritional supplement or placebo;","Participant is not pregnant or trying to become pregnant, nor breast feeding;","Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;","Participant currently ingests nicotine or has quit within the last 6 months;","Inclusion Criteria:\n\n* Participants will be male or female between the ages of 18-35 years;\n* Participants have not been consuming any nutritional supplements for the preceding 6-week period;\n* Participants have not been consuming any ergogenic aids for the preceding 6-week period;\n* Participant has provided written and dated informed consent to participate in the study;\n* Participant is willing and able to comply with the protocol;\n* Participant is apparently healthy and free from disease, as determined by a health history questionnaire;\n\nExclusion Criteria:\n\n* Participant is allergic to any ingredient in the nutritional supplement or placebo;\n* Participant is not pregnant or trying to become pregnant, nor breast feeding;\n* Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;\n* Participant currently ingests nicotine or has quit within the last 6 months;",[74],"ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"The University of Mary Hardin-Baylor","Belton","Texas","76513","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Lem Taylor, PhD","CONTACT","254-295-4895","ltaylor@umhb.edu",{"lat":89,"lon":90},31.05601,-97.46445,[92],{"name":84,"role":85,"phone":86,"email":87},[],[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Healthy Volunteers",[],{"nct_id":4,"found":58,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is a randomized, double-blind, crossover study involving 30 healthy men and women. This means participants will be randomly assigned to receive either the probiotic or a placebo, and neither they nor the researchers will know which they are receiving. Participants will also switch treatments after a break.","completed","Amino Acid Absorption with Probiotic and Milk Protein","This study is looking at how adding a single strain probiotic to milk protein affects your body's ability to absorb amino acids (the building blocks of protein). Researchers want to see if the probiotic changes how quickly and how much amino acid your body takes in. You might be able to join if you are a healthy male or female between 18 and 35 years old and haven't used nutritional supplements or performance-enhancing aids recently. The study will measure the rate and concentration of amino acid absorption at the beginning, after 22 days, and after 65 days. The current recruitment status is unclear.","Your amino acid absorption will be measured at Day 0, Day 22, and Day 65.",103,"You would participate in two three-week supplementation periods, separated by a three-week break. Each period involves daily intake of a supplement and several visits to the lab for measurements and blood draws after fasting.","Not stated in the trial record.",[],"v2"]