Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
Study NCT ID:
NCT06760468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-06
First Post:
2024-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Evaluation of Functional Probiotic Powder in Human Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactic acid', 'timeFrame': '8 weeks', 'description': 'Lactic acid：Collecting 2 ml of venous blood for measurement indicators'}, {'measure': 'Creatine kinase', 'timeFrame': '8 weeks', 'description': 'Creatine kinase: Collecting 2 ml of venous blood for measurement indicators.'}, {'measure': 'Blood urea nitrogen', 'timeFrame': '8 weeks', 'description': 'Blood urea nitrogen: Collecting 2 ml of venous blood for measurement indicators.'}, {'measure': 'Liver glycogen', 'timeFrame': '8 weeks', 'description': 'Liver glycogen: Collecting 2 ml of venous blood for measurement indicators.'}, {'measure': 'Muscle glycogen', 'timeFrame': '8 weeks', 'description': 'Muscle glycogen: Collecting 2 ml of venous blood for measurement indicators.'}, {'measure': 'Total superoxide dismutase', 'timeFrame': '8 weeks', 'description': 'Total superoxide dismutase: Collecting 2 ml of venous blood for measurement indicators.'}, {'measure': 'Glutathione', 'timeFrame': '8 weeks', 'description': 'Glutathione: Collecting 2 ml of venous blood for measurement indicators.'}, {'measure': 'Malondialdehyde', 'timeFrame': '8 weeks', 'description': 'Malondialdehyde'}], 'secondaryOutcomes': [{'measure': 'Maximum Oxygen Uptake', 'timeFrame': '8 weeks', 'description': 'The cardiopulmonary function testing system provided by the German CORTEX company measures the maximum oxygen uptake.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Fatigue']}, 'descriptionModule': {'briefSummary': 'Purpose: To optimize the preparation process of probiotic powder and assess its impact on healthy athletes, providing a scientific basis for functional foods.\n\nProcedures:\n\nProbiotic Powder Preparation: Using vacuum freeze-drying to improve bacterial survival rates.\n\nHuman Trials: Recruiting healthy athletes aged 20-30, divided into placebo and probiotic powder groups for an 8-week trial.\n\nTesting and Analysis: Conducting running exhaustion tests and blood biochemical analysis to evaluate the effects of probiotic powder.\n\nImportance: Understanding the effects of probiotics on athletes helps develop better health products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age Range: Individuals aged 20 to 30 years old.\n* Health Status: Healthy, without chronic illnesses or disabilities.\n* Athletic Background: Well-trained athletes with a history of regular physical activity.\n* Lifestyle: No history of smoking or excessive alcohol consumption.\n* Compliance and Consent: Capable of understanding and adhering to study protocols and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Chronic Illnesses: Individuals with unmanaged chronic diseases\n* Substance Use: Current smokers or individuals with a history of substance abuse.\n* Allergies and Supplements: History of food allergies or long-term use of nutritional supplements and medications.\n* Probiotic and Antibiotic Use: Use of probiotics, fermented products, or antibiotics during the study period.\n* Other Conditions: Pregnant or breastfeeding women, individuals with severe mental health conditions, or those participating in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT06760468', 'acronym': 'FPPHT', 'briefTitle': 'Development and Evaluation of Functional Probiotic Powder in Human Trials', 'organization': {'class': 'OTHER', 'fullName': 'Chengdu Sport University'}, 'officialTitle': 'Functional Probiotic Powder Human Trials', 'orgStudyIdInfo': {'id': 'SSC202408'}, 'secondaryIdInfos': [{'id': '2024YFHZ0077', 'type': 'OTHER_GRANT', 'domain': 'Sichuan Provincial Regional Innovation Cooperation Project.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Randomly select 30 healthy and well-trained athletes aged between 20 and 30 to serve as the experimental group. Participants in the experimental group will undergo an 8-week probiotic powder supplementation intervention. The dosage of the probiotic powder is set at 1x10\\^9 CFU/kg·bw·d, which means ingesting 10 billion CFU (Colony-Forming Units) of probiotics per kilogram of body weight per day. Before the intervention begins, a comprehensive health assessment and exercise capacity test will be conducted for the participants.\n\nBlood samples will be collected for baseline biochemical marker analysis. Participants will be instructed to take the probiotic powder once a day at the same time to ensure the consistency of the dosage and the standardization of the intervention.\n\nParticipants will be asked to record their daily consumption, including the time of intake, any omissions, or discomfort. After the 8-week intervention, exercise capacity tests and blood sample collections will be condu', 'interventionNames': ['Other: Control', 'Dietary Supplement: Experimental Group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Description: Arm Description: Randomly select 30 healthy and well-trained athletes aged between 20 and 30 to serve as the control group. Participants in the control group will undergo an 8-week placebo supplementation intervention. The placebo has a similar appearance and taste to the probiotic powder but does not contain active probiotic ingredients. Before the intervention begins, a comprehensive health assessment and exercise capacity test will be conducted for the participants. Blood samples will be collected for baseline biochemical marker analysis. Participants will be instructed to take the placebo once a day at the same time to ensure the consistency and standardization of the intervention. Participants will be asked to record their daily consumption, including the time of intake, any omissions, or discomfort. After the 8-week intervention, exercise capacity tests and blood sample collections will be conducted again. Comparing exercise perf'}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Arm Description: Randomly select 30 healthy and well-trained athletes aged between 20 and 30 to serve as the control group. Participants in the control group will undergo an 8-week placebo supplementation intervention. The placebo has a similar appearance and taste to the probiotic powder but does not contain active probiotic ingredients. Before the intervention begins, a comprehensive health assessment and exercise capacity test will be conducted for the participants. Blood samples will be collected for baseline biochemical marker analysis. Participants will be instructed to take the placebo once a day at the same time to ensure the consistency and standardization of the intervention. Participants will be asked to record their daily consumption, including the time of intake, any omissions, or discomfort. After the 8-week intervention, exercise capacity tests and blood sample collections will be conducted again. Comparing exercise performance and biochemical markers before and after t', 'armGroupLabels': ['Experimental group']}, {'name': 'Experimental Group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental:\n\nArm Description: Randomly select 30 healthy and well-trained athletes aged between 20 and 30 to serve as the experimental group. Participants in the experimental group will undergo an 8-week probiotic powder supplementation intervention. The dosage of the probiotic powder is set at 1x10\\^9 CFU/kg·bw·d, which means ingesting 10 billion CFU (Colony-Forming Units) of probiotics per kilogram of body weight per day. Before the intervention begins, a comprehensive health assessment and exercise capacity test will be conducted for the participants. Blood samples will be collected for baseline biochemical marker analysis. Participants will be instructed to take the probiotic powder once a day at the same time to ensure the consistency of the dosage and the standardization of the intervention. Participants will be asked to record their daily consumption, including the time of intake, any omissions, or discomfort. After the 8-week intervention, exercise ca', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liang Cheng', 'role': 'CONTACT', 'email': 'xuelilantian@163.com', 'phone': '+8613518196070'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Sport University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Cheng Liang', 'investigatorAffiliation': 'Chengdu Sport University'}}}}