Exercise FatigueFPPHTNCT06760468
Development and Evaluation of Functional Probiotic Powder in Human Trials
A study testing Experimental Group in people with Exercise Fatigue, run by Chengdu Sport University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Exercise Fatigue
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Exercise Fatigue
- Being tested
- Control, Experimental Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Control group
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 GroupDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactic acid
Lactic acid：Collecting 2 ml of venous blood for measurement indicators
Measured: 8 weeks
Creatine kinase
Creatine kinase: Collecting 2 ml of venous blood for measurement indicators.
Measured: 8 weeks
Blood urea nitrogen
Blood urea nitrogen: Collecting 2 ml of venous blood for measurement indicators.
Measured: 8 weeks
Liver glycogen
Liver glycogen: Collecting 2 ml of venous blood for measurement indicators.
Measured: 8 weeks
Muscle glycogen
Muscle glycogen: Collecting 2 ml of venous blood for measurement indicators.
Measured: 8 weeks
Total superoxide dismutase
Total superoxide dismutase: Collecting 2 ml of venous blood for measurement indicators.
Measured: 8 weeks
Glutathione
Glutathione: Collecting 2 ml of venous blood for measurement indicators.
Measured: 8 weeks
Malondialdehyde
Malondialdehyde
Measured: 8 weeks
Secondary outcomes (1)
Maximum Oxygen Uptake
The cardiopulmonary function testing system provided by the German CORTEX company measures the maximum oxygen uptake.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Liang, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760468
- Sponsor's protocol ID
- SSC202408
- Other IDs
- 2024YFHZ0077
- Acronym
- FPPHT
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Probiotic Powder Human Trials
- ClinicalTrials.gov ID
- NCT06760468
- Acronym / sponsor ID
- FPPHT / SSC202408
- Conditions
- Exercise Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chengdu Sport UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Control, Dietary Supplement: Experimental GroupRandomly 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 |
| 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 |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: Control groupArm 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 | Experimental group |
| Experimental GroupExperimental: 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 | Dietary supplement | Experimental group |
Primary outcome
Lactic acid
Time frame: 8 weeks
Lactic acid：Collecting 2 ml of venous blood for measurement indicators
Creatine kinase
Time frame: 8 weeks
Creatine kinase: Collecting 2 ml of venous blood for measurement indicators.
Blood urea nitrogen
Time frame: 8 weeks
Blood urea nitrogen: Collecting 2 ml of venous blood for measurement indicators.
Liver glycogen
Time frame: 8 weeks
Liver glycogen: Collecting 2 ml of venous blood for measurement indicators.
Muscle glycogen
Time frame: 8 weeks
Muscle glycogen: Collecting 2 ml of venous blood for measurement indicators.
Total superoxide dismutase
Time frame: 8 weeks
Total superoxide dismutase: Collecting 2 ml of venous blood for measurement indicators.
Glutathione
Time frame: 8 weeks
Glutathione: Collecting 2 ml of venous blood for measurement indicators.
Malondialdehyde
Time frame: 8 weeks
Malondialdehyde
1 secondary outcome
Maximum Oxygen Uptake
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Exercise Fatigue, run by Chengdu Sport University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Cheng (+8613518196070, xuelilantian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactic acid (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.