None listed
Conditions
Interventions
Dietary Supplement, Others(health functional food) : Experimental (CBT-FR01): Once a day, 1 stick per time, 12 weeks, oral intake with plenty of water(probiotics 1.0x10^10 CFU/day)
Control food (Place
Sponsors
Chungju Oriental Hospital of Semyung University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals with a Body Mass Index (BMI) between 25.0 kg/m² and 34.9 kg/m² who are not currently taking any medications 2) Those who have voluntarily decided to participate after receiving and understanding a detailed explanation of this clinical trial, and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of hypersensitivity to drugs, food ingredients, herbal extracts, oriental medicine, or dietary supplements. 2. Those consuming prebiotics, probiotics, or postbiotics similar to the test product within 1 month prior to the screening date. 3. Individuals currently undergoing treatment for severe diseases (cardiovascular, immune, respiratory, hepatobiliary, renal/urinary, neurological, musculoskeletal, psychiatric, infectious) or malignant tumors. 4.Those who have used weight-affecting drugs or supplements within 3 months prior to screening (e.g., anti-obesity drugs, antidepressants, antipsychotics, hormonal contraceptives, steroids, female hormones, calcium/vitamin D, weight-loss health functional foods, or meal replacements). 5. Individuals who have participated in commercial weight loss programs or medical treatments for body fat/weight reduction within 3 months prior to screening. 6. Those who have experienced a weight change of 10% or more within 3 months prior to screening. 7. Individuals with a history of surgical procedures for weight loss (e.g., gastric bypass, intestinal resection) within 6 months prior to screening. 8. Those who started beta-blockers or diuretics within 6 months prior to screening, or whose dosage is expected to change during the study (participation is allowed if the dosage has been stable for over 6 months). 9. Individuals with a history of severe psychiatric disorders (e.g., schizophrenia, epilepsy, anorexia, bulimia) or alcohol/drug abuse. 10. Those diagnosed with and receiving treatment for gastrointestinal or metabolic diseases (e.g., dyspepsia, Crohn’s disease, metabolic syndrome, irritable bowel syndrome). 11. Individuals with clinically significant risk factors for gastrointestinal bleeding or other bleeding tendencies as determined by the investigator. 12. Those judged unable to exercise due to musculoskeletal disorders. 13. Individuals with TSH levels 10 µU/mL. 14. Those with endocrine disorders such as hypothyroidism or Cushing's syndrome. 15. Individuals with renal disease or an eGFR 160 mmHg or DBP > 100 mmHg). 17. Those with uncontrolled blood glucose (Fasting Blood Glucose > 126 mg/dL). 18. Individuals with liver disease or AST/ALT levels > 3 times the upper limit of normal (ULN) at the site. 19. Those diagnosed with a malignant tumor within 5 years prior to screening. 20. Individuals who started quitting smoking within 3 months prior to screening, or current smokers planning to quit during the study period. 21. Those who participated in other clinical trials within 3 months prior to screening. 22. Women who are pregnant or breastfeeding, or planning to become pregnant during the study. 23. Individuals judged unsuitable for participation by the investigator for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Fat Percentage | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight;Body Mass Index;Waist circumference;Hip circumference;Waist-to-hip ratio (WHR);Body fat mass;Lean body mass;Visceral fat area;Subcutaneous fat area;Total abdominal fat area;Visceral-to-subcutaneous fat ratio (VSR);Total cholesterol ;High density lipoprotein cholesterol(HDL-cholesterol);Low density lipoprotein cholesterol(LDL-cholesterol);Triglycerides;Adiponectin;Leptin;Malondialdehyde (MDA);Lipoprotein Lipase(LPL) | — |
Countries
Korea, Republic of
Contacts
Public ContactSu-Hyeon Jeong
Chungju Oriental Hospital of Semyung University
Outcome results
None listed