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

Functional Probiotic Powder Human Trials

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise Fatigue
• Intervention / Treatment: Other: Control; Dietary supplement: Experimental Group

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liang Cheng; Phone Number: +8613518196070; Email: xuelilantian@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Control group; 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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Oxygen Uptake	The cardiopulmonary function testing system provided by the German CORTEX company measures the maximum oxygen uptake.	8 weeks

Collaborators and Investigators

• Sponsor: Chengdu Sport University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: SSC202408; 2024YFHZ0077 (Other Grant/Funding Number: Sichuan Provincial Regional Innovation Cooperation Project.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No