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NCT Number: NCT06760468

Development and Evaluation of Functional Probiotic Powder in 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.

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Key information

Conditions

Exercise Fatigue

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Control 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

Primary outcomes

  1. Lactic acid

    Time frame: 8 weeks

    Lactic acid：Collecting 2 ml of venous blood for measurement indicators

  2. Creatine kinase

    Time frame: 8 weeks

    Creatine kinase: Collecting 2 ml of venous blood for measurement indicators.

  3. Blood urea nitrogen

    Time frame: 8 weeks

    Blood urea nitrogen: Collecting 2 ml of venous blood for measurement indicators.

  4. Liver glycogen

    Time frame: 8 weeks

    Liver glycogen: Collecting 2 ml of venous blood for measurement indicators.

  5. Muscle glycogen

    Time frame: 8 weeks

    Muscle glycogen: Collecting 2 ml of venous blood for measurement indicators.

  6. Total superoxide dismutase

    Time frame: 8 weeks

    Total superoxide dismutase: Collecting 2 ml of venous blood for measurement indicators.

  7. Glutathione

    Time frame: 8 weeks

    Glutathione: Collecting 2 ml of venous blood for measurement indicators.

  8. Malondialdehyde

    Time frame: 8 weeks

    Malondialdehyde

Secondary outcomes

  1. Maximum Oxygen Uptake

    Time frame: 8 weeks

    The cardiopulmonary function testing system provided by the German CORTEX company measures the maximum oxygen uptake.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Cheng

CONTACT

[email protected]

+8613518196070

Sponsors and collaborators

Lead sponsor

Chengdu Sport University

Other

Registry information

Official study title

Functional Probiotic Powder Human Trials

Acronym: FPPHT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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