None listed
Conditions
Interventions
Dietary Supplement : This study is a single-center, randomized, double-blind, placebo-controlled, prospective interventional clinical trial designed to evaluate the functionality of the health functio
Sponsors
H Plus Yangji Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 to 65 years. 2) Individuals with a body mass index (BMI) classified as overweight (25.0–29.9 kg/m²) who are not taking related medications. 3) Individuals who voluntarily consent to participate in this human clinical trial, understand the study methods and procedures, and are capable of complying with them.
Exclusion criteria
Exclusion criteria: 1) Individuals who have experienced a weight change of 5 kg or more (gain or loss) within the past 3 months. 2) Individuals who have undergone surgery within the past 6 months or bariatric surgery within the past year. 3) Individuals with any of the following conditions: ? Mental disorders (depression, schizophrenia) or those who have received psychological therapy ? History of cardiovascular or cerebrovascular disease, arrhythmia, heart failure, myocardial infarction, or use of a pacemaker ? Patients with diabetes who are undergoing medication or whose condition is uncontrolled ? Gastrointestinal diseases such as Crohn’s disease, history of gastrointestinal resection surgery, or irritable bowel syndrome ? Liver failure, renal failure, malabsorption syndrome, autoimmune diseases, or cancer ? Thyroid hormone disorders or diseases that may affect body weight ? History of anemia, porphyria, pancreatic disease, or eating disorders ? Clinically significant diseases that may render participation in the trial impossible 4) Pregnant or breastfeeding women, or those planning to become pregnant during the trial period. 5) Women who have given birth within the past 6 months. 6) Individuals addicted to drugs or taking any of the following medications: ? Anti-obesity drugs, insulin, diabetes medications, diuretics ? Corticosteroids, antidepressants, antiepileptic drugs, hormonal contraceptives (for women) ? Medications affecting energy metabolism, blood glucose, appetite, or gastrointestinal activity ? Medications influencing carbohydrate and lipid metabolism, body weight, or hormones ? Immunosuppressants, proton pump inhibitors, H2 blockers, non-steroidal anti-inflammatory drugs (NSAIDs) 7) Individuals currently on a diet within the past year or who have participated in a weight loss program within the past 3 months. 8) Individuals who have received subcutaneous injections (e.g., heparin, insulin) within the past year. 9) Individuals with allergies or adverse reactions to any components contained in the test or control food: ? Test food: Heat-treated and dried culture of Bifidobacterium longum HN001 ? Control food: Corn starch 10) Individuals with alcohol addiction or who regularly consume alcohol above the following limits: ? Men: More than 40 g/day (approximately 4 beers or 4 soju shots) ? Women: More than 20 g/day (approximately 2 beers or 2 soju shots) 11) Individuals who smoke excessively (= 20 cigarettes per day). 12) Individuals who have consumed the same or similar probiotic products as the test food within the past month. 13) Individuals who have taken medications or health supplements related to body fat reduction within the past 3 months. 14) Individuals who have participated or plan to participate in other human clinical trials or clinical studies within the past 3 months. 15) Individuals showing any of the following results in diagnostic laboratory tests: ? AST, ALT levels three times above the reference range ? eGFR < 60 mL/min/1.73 m² ? Thyroid-stimulating hormone (TSH) levels outside the normal institutional reference range 16) Individuals deemed unsuitable for participation in the study by the principal investigator based on diagnostic test results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat mass and body fat percentage (DEXA; dual-energy X-ray absorptiometry);Total abdominal fat area;visceral fat area;subcutaneous fat area;visceral-to-subcutaneous fat area ratio;Safety assessment (monitoring of adverse events including subjective and objective symptoms);Safety assessment (laboratory tests);Safety assessment (vital signs);Safety assessment (electrocardiogram);Safety assessment (physical examination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lean body mass (DEXA; dual energy X-ray absorptiometry) ;Anthropometric indices (body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio) ;Lipid profile indicators (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides);Inflammatory marker (high-sensitivity C-reactive protein [hs-CRP]) ; Metabolic regulatory hormones (leptin, insulin, adiponectin); Energy metabolism regulators (UCP, PGC-1a) | — |
Countries
Korea, Republic of
Contacts
Public ContactGa Hyun Ha
H Plus Yangji Hospital
Outcome results
None listed