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Not yet recruiting NCT06760468

Development and Evaluation of Functional Probiotic Powder in Human Trials

No phase Interventional Exercise Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control, Experimental Group.
Who it may be relevant to
Registry conditions: Exercise Fatigue. Basic parameters: 20 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Functional Probiotic Powder Human Trials

Overview

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

  • Other Control
    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 coll
  • Dietary supplement Experimental 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

Primary outcome measures

  • Lactic acid [Time frame: 8 weeks]
  • Creatine kinase [Time frame: 8 weeks]
  • Blood urea nitrogen [Time frame: 8 weeks]
  • Liver glycogen [Time frame: 8 weeks]
  • Muscle glycogen [Time frame: 8 weeks]
  • Total superoxide dismutase [Time frame: 8 weeks]
  • Glutathione [Time frame: 8 weeks]
  • Malondialdehyde [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Maximum Oxygen Uptake [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06760468 · SSC202408 · 2024YFHZ0077

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗