None listed
Conditions
Interventions
Others(health functional food) : Experimental (EPRG-Pro): Once a day, 1 stick per time, 12 weeks, oral intake with plenty of water (probiotics 1.0x10^10 CFU/day)
Control food (Placebo): Once a day, 1
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adult males aged 19 to 60 years 2) A person who has agreed to participate in the human body application test before the commencement of the human body application test and has prepared an Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) A person who currently under treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous systems, endocine systems, psychotropic, infectious diseases and malignant tumors 2) A person who has history of malignant tumor within 5 years on the basis of visit 1 3) A person who has tuberculosis, multiple sclerosis, hypothyroidism, or asthma that is not controlled by medication 4) Patients with major depressive disorder, bipolar affective disorder, schizophrenia, dementia, delusional disorder, and insomnia 5) A person who intaked exercise performance and muscle strength-related health functional foods {CaHMB (Calcium ß-Hydroxy-ß-methylbutyrate), Lactiplantibacillus plantarum TWK10 probiotics, Turmeric extract, fermented oyster extract, L-carnitine tartrate, etc.} within 1 month (30 day) on the basis of visit 1 6) A person who have started taking or ingesting drugs, health functional foods (ginseng, Red ginseng, Rhodiola sachalinensis extract, Hemohim Angelica gigas mixed extract, Hovenia dulcis fruit extract, etc.), and vitamins that may affect fatigue within 1 month on the basis of Visit 1 (However, if there has been no change in medication or dosage since 1 month prior on the basis to Visit 1, participation in the test and concurrent use are possible without change during the test period) 7) A person who have used the following drugs or foods within 2 weeks on the basis of visit 1 ? Systemic antibiotics, Systemic antimicrobials, and intestinal drug ? Probiotics products taken continuously (more than 4 times a week) 8) A person who have Body Mass Index(BMI) less than 18.5 kg/m^2 or more than 30 kg/m^2 9) A person who with anemia (Hb less than 13 g/dL) 10) A person who clinically significant abnormal results on the electrocardiogram of Visit 1 11) A person who excessive smokers (20 or more per day) 12) A person who chronically consumes alcohol (an average of 40 g or more of alcohol per day (280 g/week)) 13) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 14) A person who TSH is less than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/Ml 15) A person with an eGFR of less than 60 mL/min/1.73 m^2 16) Patients with uncontrolled diabetes (HbA1c>7.0%) 17) Patients with uncontrolled hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg, and measurement criteria after stabilizing for 10 minutes in the test subjects)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exercise stress test (VO2max, Anaerobic Threshold(AT), Ventilatory Threshold(VT), Maximal Minute Ventilation(VEmax), (Maximal Respiratory Quotient)RQmax, Rating of Perceived Exertion(RPE), Time and Distance to Exhaustion, Heart Rate);Handgrip strength;Muscle endurance;Blood Indicators related to Fatigue and Muscle(Lactate, Ammonia, Free Fatty Acid, Total Ketone Body, Creatine Kinase, Inorganic Phosphorus, LDH, BUN, Creatinine) | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS (Numeric Rating Scale);KSF-36;Microbiome;Adverse Event;Clinical pathology test (Hematological/blood chemical test, Urine test);Vital signs (Blood pressure, Pulse), Physical measurements (Weight);Electrocardiogram test | — |
Countries
Korea, Republic of
Contacts
Public ContactSoowan Chae
Jeonbuk National University Hospital
Outcome results
None listed