Development and Evaluation of Functional Probiotic Powder in Human Trials

Not Applicable

Not yet recruiting

• Conditions: Exercise Fatigue

• Registration Number: NCT06760468
• Lead Sponsor: Chengdu Sport University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-26
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-02-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age Range: Individuals aged 20 to 30 years old.
• 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

• Chronic Illnesses: Individuals with unmanaged chronic diseases
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lactic acid	8 weeks	Lactic acid：Collecting 2 ml of venous blood for measurement indicators
Creatine kinase	8 weeks	Creatine kinase: Collecting 2 ml of venous blood for measurement indicators.
Blood urea nitrogen	8 weeks	Blood urea nitrogen: Collecting 2 ml of venous blood for measurement indicators.
Liver glycogen	8 weeks	Liver glycogen: Collecting 2 ml of venous blood for measurement indicators.
Muscle glycogen	8 weeks	Muscle glycogen: Collecting 2 ml of venous blood for measurement indicators.
Total superoxide dismutase	8 weeks	Total superoxide dismutase: Collecting 2 ml of venous blood for measurement indicators.
Glutathione	8 weeks	Glutathione: Collecting 2 ml of venous blood for measurement indicators.
Malondialdehyde	8 weeks	Malondialdehyde

Secondary Outcome Measures

Name	Time	Method
Maximum Oxygen Uptake	8 weeks	The cardiopulmonary function testing system provided by the German CORTEX company measures the maximum oxygen uptake.