overweight or obesity
Conditions
Interventions
Low-dose group:AKM Lab-01 Enteric-coated Capsules 34 Billion TFU
High-dose group:AKM Lab-01 Enteric-coated Capsules 1000 Billion TFU
Placebo control group:AKM Lab-01 Enteric-coated Capsule Placebo
Sponsors
Guangzhou Development District Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 60 years (inclusive), male or female; 2.Overweight/obesity (24.0 <= BMI <= 40.0 kg/m²); 3.No use of any medications for metabolic control (e.g., weight, blood lipids, blood glucose) within the past month. 4.Participants have managed their weight solely through lifestyle interventions (diet and exercise) for at least one month prior to the screening period; 5.Participants possess adequate communication and cognitive abilities, are capable of adhering to long-term medication use, and have understood the nature, significance, potential benefits, inconveniences, and risks of the study before its commencement; 6.Eligible participants of childbearing potential (male or female) must agree to use a medically approved contraceptive method (e.g., intrauterine device [IUD], oral contraceptives, or condoms) during the trial period. Female participants of childbearing age must have a negative blood pregnancy test result during the screening period and must not be breastfeeding. 7.All participants must voluntarily enroll, provide signed informed consent, and comply with the trial treatment regimen and visit schedule.
Exclusion criteria
Exclusion criteria: 1. Clear history of neurological or psychiatric disorders (including epilepsy and dementia); 2. Hyperlipidemia due to secondary causes (e.g., nephrotic syndrome, hepatic diseases, hypothyroidism, renal failure, etc.); 3. Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as poorly controlled diabetes, severe hypertriglyceridemia, cerebrovascular diseases, etc.; 4. Patients with severe primary diseases of the liver, kidney, hematopoietic system, or psychiatric disorders; 5. Subjects with a family history of genetically inherited metabolic diseases; 6. Subjects currently taking hepatotropic medications; 7. Subjects who have previously undergone bariatric surgery; 8.Subjects with uncontrolled or unstable acute/chronic diseases, including but not limited to: • Cardiovascular diseases: unstable angina, myocardial infarction within the past 6 months, symptomatic congestive heart failure (NYHA Class II or above), severe arrhythmias, etc.; • Uncontrolled active infectious diseases, malignancies, etc.; 9. Subjects with hepatic or renal insufficiency: • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN; • Serum total bilirubin > 1.5 × ULN; • Serum creatinine (Cr) > 1.5 × ULN; 10. Urine amylase>= 1.5 × ULN, or other laboratory abnormalities considered clinically significant by the investigator that do not meet the inclusion criteria; 11. Acute diabetic complications within the past 3 months, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state; 12. History of gastrointestinal surgery within the past year, or severe active gastrointestinal disease with unstable condition that may affect drug absorption, distribution, metabolism, or excretion; 13. Allergic constitution or known allergy to the active or excipient ingredients of the investigational product; 14. Use of antibiotic therapy, probiotics, or other prebiotic preparations within 3 months prior to recruitment; 15. Excessive alcohol consumption in the past 10 years (>30 g/day for males, >20 g/day for females); 16. Pregnant or breastfeeding subjects; 17. Any other condition considered by the investigator to potentially worsen or endanger subject safety due to participation in the study. The specific reason for exclusion must be documented.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight;BMI;Body Composition; | — |
Countries
China
Contacts
Public ContactZhiying He
Guangzhou Development District Hospital
Outcome results
None listed