[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"safety-and-tolerability-in-healthy-volunteers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:safety-and-tolerability-in-healthy-volunteers":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641080","safety-and-user-experience-of-bp-cbb-100641080",false,"NCT07628608","Safety and User Experience of BP-CBB","A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein CBB (BP-CBB)","Inclusion Criteria:\n\n1. Be able to give written informed consent.\n2. Be between 18-65 years, both inclusive.\n3. Record greater than 3 bowel movements recorded during the one-week run-in period.\n4. In general, in good health, as determined by the investigator.\n5. Willing to consume the Study Product once daily for the duration of the study.\n6. Willing to avoid pro, pre post biotics and any new supplements for the duration of the study\n\nExclusion Criteria:\n\n1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and\u002For currently breastfeeding.\n2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:\n\n   1. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).\n   2. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.\n   3. Sexual partner(s) is\u002Fare exclusively female.\n   4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.\n   5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.\n3. Has a history of drug and\u002For alcohol abuse.\n4. Has known food allergies, history of Type I (IgE-mediated) food allergies, or hypersensitivity or other issues with foods or ingredients that would preclude intake of the Study Product (i.e. soya).\n5. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:\n\n   1. Diagnosed gastrointestinal conditions\n   2. Previous bariatric surgery\n   3. Immunocompromised health conditions\n6. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:\n\n   1. Systemic antibiotics - in the 4 weeks prior to Visit 1\n   2. Proton pump inhibitors (PPIs) - in the past 4 prior to Visit 1\n   3. Non-steroidal anti-inflammatory drugs (NSAIDs) - in the past 2 weeks prior to Visit 1\n   4. GLP-1 agonists - in the 12 weeks prior to Visit 1\n   5. SGLT-2 inhibitors - in the 12 weeks prior to Visit 1\n7. Current or recent (in the 4-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:\n\n   1. Probiotics\n   2. Prebiotics\n   3. Synbiotics\n   4. Postbiotics\n8. Regular (weekly) consumption of fermented food products (e.g. kefir, kombucha)\n9. Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, exercise, diet, change in body weight).\n10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.\n11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer experience with using the product, and to set the scene for future human studies documenting the health-benefits of daily supplementation with BP-CBB for diverse populations.",[28],"Safety and Tolerability in Healthy Volunteers",[30,31,32,33,34,35],"healthy volunteer","first-in-human","binding protein","safety","Tolerability","User experience","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2026-06-16",{"date":44,"type":22},"2026-12-01",{"name":46,"class":47},"Bactolife A\u002FS","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100619597","phase-1-a-study-testing-the-effects-of-different-thc-doses-on-psychological-and-biological-function-100619597","NCT07346690","A Study Testing the Effects of Different THC Doses on Psychological and Biological Function","Acute Dose-Dependent Effects of Oral THC on Physiological and Subjective Responses in Healthy Cannabis-Experienced Adults","DRATT","Inclusion Criteria:\n\n* Adults aged 18-55\n* No major medical or psychiatric conditions\n* At least one previous, well-tolerated experience with cannabis\n* Not currently pregnant or breastfeeding\n\nExclusion Criteria:\n\n* Family history (first- or second-degree relatives) of bipolar disorder, psychosis, or schizophrenia\n* Significant negative reaction to cannabis in the past or known allergy to cannabis products\n* Currently using recreational drugs","55 Years",{"count":59,"type":22},24,[61],"PHASE1","The goal of this clinical trial is to learn how a investigational medicinal product (THC) affects psychological and physical responses in healthy adults with prior cannabis use experience. The main questions it aims to answer are:\n\n\\- How do different dose levels of the investigational medicinal product (THC) influence short-term subjective and physiological responses?\n\nResearchers will compare three dose levels of the study drug to a placebo (a look-alike substance with no active ingredient) to see how responses vary across sessions.\n\nParticipants will:\n\n* Attend four in-person study visits, each involving a single dose of either the study drug or placebo\n* Complete questionnaires about their moment-to-moment experiences\n* Have their heart rate, blood pressure, and other physical measures monitored\n* Undergo serial blood sampling to measure circulating biomarkers",[64,65,66,28],"Evaluate PK Profile","Evaluate PD Profile","Healthy Adults",[68,69],"Cannabinoid","Cannabis","NOT_YET_RECRUITING","2026-01-07",{"date":73,"type":40},"2026-01-16",{"date":75,"type":22},"2026-02-01",{"date":77,"type":22},"2028-02-01",{"name":79,"class":80},"University of Calgary","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":48},"100584862","effects-of-lentil-protein-hydrolysate-on-blood-pressure-control-vascular-function-and-exercise-performance-100584862","NCT06894875","Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance","Examining the Safety and Tolerability of Lentil Protein Hydrolysate in Healthy Males and Females Whilst Exploring the Effects of a Dose Range on Blood Pressure Control and Vascular Function and Exercise Performance","Inclusion Criteria:\n\n* Willing to provide written and dated informed consent to participate in the study.\n* Willing and able to comply with the protocol.\n* Are not on any medication, or supplements which would impact the trial in the opinions of the investigator or Sponsor.\n* Male or female between 18 and 45 years of age (18.5 kg\u002Fm2 ≥ BMI \\\u003C 30 kg\u002Fm2).\n* Comply with ACSM guidelines for physical activity.\n* Have not participated in a clinical trial within the past month and agree to not participate in another clinical trial during the study period.\n* Agree to not significantly alter diet or exercise routine during the trial period.\n* Willing to wear a wearable device continuously for the duration of the study\n\nExclusion Criteria:\n\n* Subjects having a known allergy or hypersensitivity to any of the ingredients in the investigational products.\n* Subjects with a history of alcohol and\u002For other drug abuse in the past year.\n* Has performed strenuous exercise (rating of perceived exertion ≥ 13) ≤ 48 hours before laboratory visit (Borg, 1982).\n* Consuming \\>14 alcoholic drinks per week or \\> 2 drinks\u002Fday in the 48 hours preceding a clinic visit.\n* Active smokers, nicotine use or vaping\n* Subjects suffering from a sleep disorder and\u002For who have a known history of (or was being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s) that might put the subject at risk and\u002For confounded the results of the study.\n* Subjects with a history of being diagnosed with phenylketonuria or another disease affecting amino acid metabolism (i.e., maple syrup urine disease, etc.).\n* Subjects with an elevated resting heart rate (\\>100 bpm) or blood pressure (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg).\n* Pregnant or lactating women\n* Presentation of orthostatic hypotension during the screening and familiarisation study visit\n* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.","45 Years",{"count":90,"type":22},48,[25],"Examining the safety and tolerability of Lentil Protein Hydrolysate in healthy males and females whilst exploring the effects of a dose range on blood pressure control and vascular function and exercise performance",[94,95,96,97,98,28],"Exercise","Blood Pressure","Vasodilation","Vascular Function in Healthy Volunteers","Exercise Performance",[100,101,102,103],"Exercise performance","Vascular function","blood pressure control","Lentil protein hydrolysate","2025-12-15",{"date":106,"type":40},"2025-12-16",{"date":108,"type":40},"2025-06-24",{"date":110,"type":22},"2026-03-30",{"name":112,"class":47},"Nuritas Ltd"]