None listed
Conditions
Interventions
Dietary Supplement : One capsule(450mg) was orally administered once daily for 12 weeks.
- Test: Lactiplantibacillus plantarum ATG-K2
- placebo(Except for the raw materials of the test product, the f
Sponsors
AtoGen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults aged between 19 and 65 years at the time of screening. (2) Individuals who meet both of the following criteria: ? Body Mass Index(BMI) between 25 kg/m² and 32 kg/m² ? Waist circumference of at least 90 cm for males and 85 cm for females. (3) A person who voluntarily signed a written informed consent form
Exclusion criteria
Exclusion criteria: (1) Body weight change of more than 10% within 3 months prior to the screening visit. (2) History of bariatric or other surgical procedures for weight loss (e.g., gastrectomy) (3) Current or past medical history of endocrine disorders(hypothyroidism, Cushing's syndrome, etc.) that may affect weight (4) Clinically significant abnormal values in thyroid function tests(TSH, Free T4). (5) History of malignancy within 5 years prior to study participation. (6) SBP =160 mmHg or DBP =100 mmHg (those whose blood pressure is stably controlled through medication can participate) (7) Use of beta-blockers or diuretics for hypertension (8) Type 1 or type 2 diabetes and currently taking anti-diabetic medication. (9) lipid-lowering agents(HMG-CoA reductase inhibitors, fibrate derivatives, etc.) within 1 month prior to the screening visit. (10) Individuals who have taken or are taking medications that may affect weight within 1 month prior to the screening visit, including anti-obesity drugs, psychiatric drugs, CNS drugs, oral corticosteroids, oral contraceptives, cyproheptadine, female hormone preparations, etc. (11) Antibiotics within 1 month prior to the screening examination. (12) Regular consumption (=4 times/week) of probiotics or fermented dairy products (e.g., yogurt, cheese) within 2 weeks prior to the screening examination. (13) Use of dietary supplements for weight loss within 1 month prior to the screening visit (14) Excessive alcohol consumption (>14 units/week) (15) Participation in commercial weight-loss programs or consistent use of diet products within 3 months prior to the screening visit (16) Clinically significant disorders of the cerebrovascular, cardiovascular, hepatobiliary, renal, nervous, respiratory, endocrine, hematologic, urogenital, psychiatric, musculoskeletal, or immune systems, as determined by the principal investigator (17) Hypersensitivity or clinically significant allergic reactions to any ingredient of the investigational product (probiotics). (18) Alcohol dependence, substance abuse, or drug addiction. (19) Gastrointestinal disorders (e.g., Crohn’s disease) or history of gastrointestinal surgery that may affect absorption of the investigational product (excluding simple appendectomy or hernia surgery). (20) Another human study within 3 months prior to the screening examination. (21) Clinically significant abnormalities in laboratory test results (22) Pregnant or lactating women. (23) Determination of ineligibility for study participation by the principal investigator based on clinical judgment or laboratory findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat mass and body fat percentage measured by DEXA (dual-energy X-ray absorptiometry);Abdominal fat area measured by CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric measurements;body fat indicators measured by bioelectrical impedance analysis, BIA;lean mass measured by DEXA (dual-energy X-ray absorptiometry);lipid profile;Obesity-related hormones;Inflammatory indicators | — |
Countries
Korea, Republic of
Contacts
Public ContactEunock Park
Jeonbuk National University Hospital
Outcome results
None listed