[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07206407":3,"trial-entities:NCT07206407":104,"trial-summary:NCT07206407":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":74,"locations":77,"central_contacts":96,"overall_officials":99,"references":102,"see_also_links":103},"NCT07206407","058-010","Clinical Trial on Rapid Immune Modulating Effects","RECRUITING","2026-03-01","2025-09","2025-12-17","2025-09-28","Natural Immune Systems Inc","OTHER",false,"The goal for this clinical trial is to document rapid effects of a nutritional blend on immune cells. A double-blind, placebo-controlled, cross-over study design will be used.","Clinical trial comparing the acute immune effects of a nutraceutical blend, and a placebo. The nutraceutical blend is based on low molecular weight peptides isolated from cow colostrum ultrafiltrate, mushroom extracts, and vitamin C.\n\n24 subjects will participate in a placebo-controlled, randomized, double-blinded, cross-over study design, wherein they will be consuming placebo or the active nutraceutical blend, separated by a 1-week washout period.\n\nBaseline blood samples are taken 1 hour after participants arrive; the dose is then administered. Additional blood samples are taken 1 hour, 2 hours, and 3 hours following consumption of test product.",[18],"Immune Surveillance",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},24,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIETARY_SUPPLEMENT","Placebo","Four capsules.",[33,34],"Experimental: Crossover group 1, randomized","Experimental: Crossover group 2, randomized",{"type":29,"name":36,"description":31,"armGroupLabels":37},"Nutraceutical blend",[33,34],[39],{"measure":40,"description":41,"timeFrame":42},"Immune cell surveillance","Observation of changes in immune cell trafficking, i.e., the changes in immune cell numbers in the peripheral blood following administration. Data is collected as 'cell numbers per uL whole blood' for the following immune cell types:\n\n* Monocytes\n* NK cells\n* NKT cells\n* T cells\n* non-NK nonT cells","3 hours after consuming a test product for this study protocol",[44],{"measure":45,"description":46,"timeFrame":42},"Immune cell activation status","Observation of immune cell status of alertness, i.e., the changes in the expression of CD25 and CD69. Data is collected as 'mean fluorescence intensity' for the following immune cell types:\n\n* Monocytes\n* NK cells\n* NKT cells\n* T cells\n* nonNK nonT cells","ALL","18 Years","75 Years",true,{"inclusion":52,"exclusion":62,"raw_text":73},[53,54,55,56,57,58,59,60,61],"Healthy adults;","Age 18-75 years (inclusive);","Veins easy to see in one or both arms (to allow for the multiple blood draws);","Willing to comply with study procedures, including:","Maintaining a consistent diet and lifestyle routine throughout the study,","Consistent habit of bland breakfasts on days of clinic visits,","Abstaining from exercising and nutritional supplements on the morning of a study visit,","Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;","Abstaining from music, candy, gum, computer\u002Fcell phone use, during clinic visits.",[63,64,65,66,67,68,69,70,71,72],"Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);","Taking anti-inflammatory medications on a daily basis;","Currently experiencing intense stressful events\u002F life changes;","Currently in intensive athletic training (such as marathon runners);","Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;","An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);","Unwilling to maintain a constant intake of supplements over the duration of the study;","Anxiety about having blood drawn;","Pregnant, nursing, or trying to become pregnant;","Known allergies related to ingredients in active test product or placebo.","Inclusion Criteria:\n\n* Healthy adults;\n* Age 18-75 years (inclusive);\n* Veins easy to see in one or both arms (to allow for the multiple blood draws);\n* Willing to comply with study procedures, including:\n\n  * Maintaining a consistent diet and lifestyle routine throughout the study,\n  * Consistent habit of bland breakfasts on days of clinic visits,\n  * Abstaining from exercising and nutritional supplements on the morning of a study visit,\n  * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit;\n  * Abstaining from music, candy, gum, computer\u002Fcell phone use, during clinic visits.\n\nExclusion Criteria:\n\n* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);\n* Taking anti-inflammatory medications on a daily basis;\n* Currently experiencing intense stressful events\u002F life changes;\n* Currently in intensive athletic training (such as marathon runners);\n* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;\n* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);\n* Unwilling to maintain a constant intake of supplements over the duration of the study;\n* Anxiety about having blood drawn;\n* Pregnant, nursing, or trying to become pregnant;\n* Known allergies related to ingredients in active test product or placebo.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":7,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":93},"NIS Labs","Klamath Falls","Oregon","97601","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Alex S. Cruickshank","CONTACT","(541) 884-0112","alex@nislabs.com",{"name":91,"role":87,"email":92},"Gitte S. Jensen, PhD","gitte@nislabs.com",{"lat":94,"lon":95},42.22487,-121.78167,[97],{"name":91,"role":87,"phone":98,"email":92},"15418840112",[100],{"name":91,"affiliation":79,"role":101},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Healthy",[],{"nct_id":4,"found":50,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is a double-blind, placebo-controlled, cross-over study with 24 participants. This means neither you nor the study staff will know if you're receiving the Nutraceutical blend or the Placebo, and you will receive both at different times.","completed","Study on Rapid Immune Modulating Effects","This study is looking at how quickly a special nutritional blend affects your immune cells. We are comparing a \"Nutraceutical blend\" (made from cow colostrum, mushroom extracts, and vitamin C) with a \"Placebo\" (four capsules with no active ingredients). The goal is to see if the nutraceutical blend can quickly improve your immune cell surveillance, which is how your body watches for and responds to threats. We'll measure this effect within 3 hours after you take the product. We are looking for 24 healthy adults, aged 18 to 75, who have easily visible veins for blood draws and are willing to follow specific diet and lifestyle routines during the study. The current recruitment status is unclear.","Your immune cell surveillance will be measured at 3 hours after consuming a test product.",116,"You will have blood samples taken at baseline, and then 1, 2, and 3 hours after consuming a test product. You will also need to maintain a consistent diet and lifestyle, eat bland breakfasts on clinic visit days, and avoid exercise and certain nutritional items.","Not stated in the trial record.",[30,36],"v2"]