NCT06760468

Development and Evaluation of Functional Probiotic Powder in Human Trials

Functional Probiotic Powder Human Trials

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chengdu Sport University · Academic / Other
• Sex: All
• Age: 20 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

Purpose: To optimize the preparation process of probiotic powder and assess its impact on healthy athletes, providing a scientific basis for functional foods. 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.

Conditions

• Exercise Fatigue

Interventions

Type	Name	Description
OTHER	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
DIETARY_SUPPLEMENT	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

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2025-01-06
• Last updated: 2025-01-06