Development and Evaluation of Functional Probiotic Powder in Human Trials
NCT ID: NCT06760468
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-01
2025-06-01
Brief Summary
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Procedures:
Probiotic Powder Preparation: Using vacuum freeze-drying to improve bacterial survival rates.
Human Trials: Recruiting healthy athletes aged 20-30, divided into placebo and probiotic powder groups for an 8-week trial.
Testing and Analysis: Conducting running exhaustion tests and blood biochemical analysis to evaluate the effects of probiotic powder.
Importance: Understanding the effects of probiotics on athletes helps develop better health products.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental group
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 capacity tests and blood sample collections will be condu
Control
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
Experimental Group
Experimental:
Arm 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
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 perf
No interventions assigned to this group
Interventions
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Control
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
Experimental Group
Experimental:
Arm 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Health Status: Healthy, without chronic illnesses or disabilities.
* Athletic Background: Well-trained athletes with a history of regular physical activity.
* Lifestyle: No history of smoking or excessive alcohol consumption.
* Compliance and Consent: Capable of understanding and adhering to study protocols and willing to provide informed consent.
Exclusion Criteria
* Substance Use: Current smokers or individuals with a history of substance abuse.
* Allergies and Supplements: History of food allergies or long-term use of nutritional supplements and medications.
* Probiotic and Antibiotic Use: Use of probiotics, fermented products, or antibiotics during the study period.
* Other Conditions: Pregnant or breastfeeding women, individuals with severe mental health conditions, or those participating in other clinical studies.
20 Years
30 Years
ALL
No
Sponsors
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Chengdu Sport University
OTHER
Responsible Party
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Cheng Liang
Director
Central Contacts
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Other Identifiers
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2024YFHZ0077
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SSC202408
Identifier Type: -
Identifier Source: org_study_id
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