Glucolipid Metabolic Disorders
Conditions
Interventions
Low-dose bacterial intervention group:The intervention was given with SJ-2 bacteria containing 10^10CFU/ capsule, 1 capsule/day for 4 weeks
High-dose bacterial intervention group:Intervention with SJ-2 bacteria containing 10^11CFU/ capsule, 1 capsule/day, for 4 weeks
Placebo control group:Placebo was given with the same package size, 1 capsule/day for 4 weeks
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: a) Age 18-65; b) Dyslipidemia: According to"Guidelines for the prevention and treatment of dyslipidemia in adults in China",TC=5.2 mmol/L or LDL-C=3.4 mmol/L or TG=1.7 mmol/L or HDL-C24 kg/m^2 Try to meet the above four criteria at the same time, at least meet criteria a), b), d).
Exclusion criteria
Exclusion criteria: 1)The patients diagnosed with diabetes, hyperlipidemia, obesity, metabolic syndrome, non-alcoholic fatty liver disease, atherosclerosis and other metabolic diseases need drug intervention according to the guidelines; 2)According to the treatment standards of metabolic diseases such as diabetes, hyperlipidemia and obesity, drug treatment or active lifestyle intervention measures (such as diet, dietary intervention, exercise, etc.) have been taken within the past 1 month; 3)Patients with serious heart, liver, lung, kidney, blood, endocrine, nervous system diseases, mental disorders, malignant tumors, respiratory tract, digestive tract, urinary system and other parts of serious infection; 4) Pregnant women, lactating women, pregnant people who have a pregnancy plan in the next 3 months (pregnant people who have a pregnancy plan in the next 3 months will not be included in the randomized controlled study); 5) Use of viable microbial preparations, prebiotics, antibacterial drugs (antibiotics), immunosuppressants, glucocorticoids or long-term use of traditional Chinese medicine within one month; 6) Non-steroidal anti-inflammatory drugs, bile acid chelating agents or ursodeoxycholic acid were used in the last 2 weeks; 7) Allergic diseases, or oral antihistamines, mast cell stabilizers and other anti-allergy drugs; 8) The patient has a history of type 1 diabetes mellitus, celiac disease, inflammatory bowel disease, psoriasis, or other rheumatic immune system diseases or a first-degree relative; The patient has a clear history of a genetically related particular type of diabetes or familial hyperlipidemia; 9) History of abdominal surgery (except appendectomy or splenectomy); 10) A history of long-term alcohol consumption (more than 5 years, equivalent to alcohol dose =40g/d for men and 20g/d for women) or a history of heavy alcohol consumption within 2 weeks (equivalent to alcohol dose > 80g/d). 11) Have obvious movement disorder; 12) The doctor's judgment compliance is poor, and it is not appropriate to participate in this clinical researcher after evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine Blood Test;Liver Function;Kidney Function;Blood Clotting;hs-CRP;Albumin;LPS;Gastrointestinal Symptom Rating Scale;Stool Consistency Weekly Response Rate;Abdominal Discomfort Weekly Response Rate;Adverse Event/Serious Adverse Event Reporting Form; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight;BMI;Waistline;Hipline;Fasting Blood-glucose;75g OGTT;Glycosylated Hemoglobin;HOMA-IR;QUICKI;HOMA-B;TC;TG;HDL-C;LDL-C;Gut microbiome; | — |
Countries
China
Contacts
Public ContactLiping Duan?Shuangjiang Liu?Chang Liu
Peking University Third Hospital/ Institute of Microbiology, Chinese Academy of Sciences
Outcome results
None listed