Examination of the effect of Lactiplantibacillus plantarum 22A-3 on the liver function.
- Conditions
- o
- Registration Number
- JPRN-UMIN000051994
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 60
Not provided
[1] Individuals who are currently receiving drug treatment due to some kind of illness. In addition, individuals who regularly use drugs or quasi-drugs for purposes other than disease treatment. [2] Individuals who used or applied a drug for treatment of disease in the past 1 month. [3] Individuals who have, are undergoing treatment for, or have a history of serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases. [4] Individuals who contract or have a history of serious endocrine disease. [5] Individuals with serious anemia. [6] Individuals with bleeding teeth or oral problems, such as periodontal disease or mouth ulcer. [7] Individuals who may have allergic symptoms to test product or wheat, other foods, and medical products. [8] Individuals who regularly use food for specified health use, functional foods, and health foods. [9] Individuals who regularly use foods and supplements containing vitamins, lactic acid bacteria and bifidobacteria [10] Individuals who regularly drink alcohol (excessive alcohol drinkers). [11] Individuals who are smoker. (including electronic cigarettes) [12] Individuals with possible changes of lifestyle during the test period. [13] Individuals who have habits to do high-intensity exercises such as running, marathon, or soccer. [14] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [15] Individuals who participated in other clinical studies in the past 1 month. [16] Individuals who are judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALT(Week 0, Week 6 and Week 12)
- Secondary Outcome Measures
Name Time Method *Secondary outcomes [1] AST (1) [2] Gamma -GT (1) [3] Brief-type self-administered diet history questionnaire (1) *Safety [1] Blood pressure, pulsation (1) [2] Weight, body fat percentage, BMI (1) [3] Hematologic test (1) [4] Blood biochemical test (1) [5] Urine analysis (1) [6] Doctor's questions (1) [7] Adverse events: number of cases and expression rate of adverse events (2) [8] Subject's diary (3) (1): Week 0, Week 6 and Week 12 (2): Week 6, Week 12 (3): From the first day of ingestion of a test material to the last day of the test.