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Development and Evaluation of Functional Probiotic Powder in Human Trials

Functional Probiotic Powder Human Trials

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06760468
Acronym
FPPHT
Enrollment
60
Registered
2025-01-06
Start date
2025-02-01
Completion date
2025-06-01
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Fatigue

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.

Interventions

OTHERControl

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

DIETARY_SUPPLEMENTExperimental 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

Sponsors

Chengdu Sport University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Malondialdehyde8 weeksMalondialdehyde
Lactic acid8 weeksLactic acid:Collecting 2 ml of venous blood for measurement indicators
Creatine kinase8 weeksCreatine kinase: Collecting 2 ml of venous blood for measurement indicators.
Blood urea nitrogen8 weeksBlood urea nitrogen: Collecting 2 ml of venous blood for measurement indicators.
Liver glycogen8 weeksLiver glycogen: Collecting 2 ml of venous blood for measurement indicators.
Muscle glycogen8 weeksMuscle glycogen: Collecting 2 ml of venous blood for measurement indicators.
Total superoxide dismutase8 weeksTotal superoxide dismutase: Collecting 2 ml of venous blood for measurement indicators.
Glutathione8 weeksGlutathione: Collecting 2 ml of venous blood for measurement indicators.

Secondary

MeasureTime frameDescription
Maximum Oxygen Uptake8 weeksThe cardiopulmonary function testing system provided by the German CORTEX company measures the maximum oxygen uptake.

Contacts

Primary ContactLiang Cheng
xuelilantian@163.com+8613518196070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026