Health TrialsbyHealthPanel

Development and Evaluation of Functional Probiotic Powder in Human Trials

ConditionExercise Fatigue
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-30
SponsorChengdu Sport University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control

    Other intervention

    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

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Lactic acid

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

Time frame
8 weeks
2

Creatine kinase

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

Time frame
8 weeks
3

Blood urea nitrogen

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

Time frame
8 weeks
4

Liver glycogen

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

Time frame
8 weeks

Secondary outcomes

1

Maximum Oxygen Uptake

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

Time frame
8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Sport University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: