Development and Evaluation of Functional Probiotic Powder in Human Trials

NCT06760468 | Not Yet Recruiting

• 2 other identifiers: SSC2024082024YFHZ0077
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exercise Fatigue

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Maximum Oxygen Uptake

  8 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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; Dietary Supplement: Experimental Group

Control group

NO INTERVENTION

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

Interventions

Control OTHER

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

Also known as: Control group

Experimental group

Experimental Group DIETARY_SUPPLEMENT

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

Experimental group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Sport University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Liang Cheng

CONTACT

+8613518196070; xuelilantian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 6, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share