Development and Evaluation of Functional Probiotic Powder in Human Trials (FPPHT)

Chengdu Sport University

Status: Not yet enrolling

Conditions: Exercise Fatigue

Treatments: Other: Control; Dietary Supplement: Experimental Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06760468

SSC202408

2024YFHZ0077 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental group

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. 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

Treatment:

Dietary Supplement: Experimental Group

Other: Control

Control group

No Intervention 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