Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age 5-18 years old, male or female; (2) BMI= P85 of BMI of children of the same age and sex, that is, BMI Z score=1.04; (3) have not received obesity-related drug therapy or surgical treatment; (4) The subject and guardian are willing and able to cooperate with the scheduled trial procedures such as visits, treatment plans and laboratory examinations, and sign written informed consent.
Exclusion criteria
Exclusion criteria: (1) A history of drug use, including antibiotics and supplements; a. Use of medications or supplements in the past 3 months to control weight or body fat b. Use medications/supplements to control blood sugar c. Medication (drugs/supplements) for high blood pressure or dyslipidemia d. Use of laxatives or fiber supplements in the past 6 weeks e. Use a vitamin D supplement =100 µg/ day f. Use probiotic supplements within the past 6 weeks g. Frequent use of nonsteroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs h. Use proton pump inhibitors regularly (more than once a week) i. Recent (past 3 months) or continuous use of antibiotics (2) hereditary obesity (e.g. Prader Willi syndrome); (3) Those who are known to be highly allergic or allergic to probiotic products of this study; (4) Medical history: gastrointestinal disease, chronic active inflammatory disease, cardiovascular disease, liver dysfunction/disease, renal dysfunction/disease, dementia, thyroid disease, pancreatic disease, history of cancer within the past 5 years, or any other disease or condition that the investigator believes may interfere with the study results or the safety of the subjects (5) History of bariatric surgery; (6) Immunosuppression or ongoing treatment resulting in immunosuppression; (7) Atypical celiac disease; (8) other hereditary diseases; (9) Have participated in any other clinical trial within 3 months and have used drug or non-drug intervention; (10) Other conditions deemed unsuitable for inclusion in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index;Body composition;physique; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Fasting insulin;Glycosylated hemoglobin;Abdominal ultrasound;Blood routine;7 items of blood lipids;Gut Microbiota;Interleukin-6;Interleukin-10;Tumor necrosis factor-a;lipopolysaccharide;High-sensitivity C-reactive protein;25-hydroxy vitamin D ;amino acid metabolism;short chain fatty acids;Liver and kidney function;Routine urine test; | — |
Countries
China
Contacts
Affiliated Hospital of Hangzhou Normal University