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The purpose of this study is to determine whether the probiotics will be effective in the treatment of obesity
This study aims to evaluate the effect of probiotics on the improvement of glucose and lipid metabolism, as well as the gut microbiota.Baseline, 1 month and 3 months data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical practice for obesity patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. |
|
| Placebo | Placebo Comparator | the patients in this arm will receive placebo with similar appearance of probiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in fasting blood-glucose at 1 month | change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline | 1 month |
| change from baseline in fasting blood-glucose at 3 months | change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline | 3 months |
| change from baseline in glycosylated hemoglobin change at 1 month | change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline | 1 month |
| change from baseline in glycosylated hemoglobin change at 3 months | change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in gut microbiota at 1 month | study the microbiota change of stool samples at 1 month in comparison with the baseline | 1 month |
| change from baseline in gut microbiota at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuiling Zhu, MD | Contact | 18817951953 | 1263856671@qq.com | |
| Renyuan Gao, MD | Contact | 15601675695 | renyuangao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Huanlong Qin | Shanghai 10th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 10th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | the patients in this arm will receive placebo intervention |
|
study the microbiota change of stool samples at 3 months in comparison with the baseline
| 3 months |
| change from baseline in triglyceride at 1 month | 1 month |
| change from baseline in triglyceride at 3 months | 3 months |
| change from baseline in cholesterol at 1 month | 1 month |
| change from baseline in cholesterol at 3 months | 3 months |
| change from baseline in high-density lipoprotein at 1 month | 1 month |
| change from baseline in high-density lipoprotein at 3 months | 3 months |
| change from baseline in low-density lipoprotein at 1 month | 1 month |
| change from baseline in low-density lipoprotein at 3 months | 3 months |
| change from baseline in glutamic oxalacetic transaminase at 1 month | 1 month |
| change from baseline in glutamic oxalacetic transaminase at 3 months | 3 months |
| change from baseline in alkaline transaminase at 1 month | 1 month |
| change from baseline in alkaline transaminase at 3 months | 3 months |
| change from baseline in alkaline phosphatase at 1 month | 1 month |
| change from baseline in alkaline phosphatase at 3 months | 3 months |
| change from baseline in superoxide dismutase at 1 month | 1 month |
| change from baseline in superoxide dismutase at 3 months | 3 months |
| change from baseline in C-reactive protein at 1 month | 1 month |
| change from baseline in C-reactive protein at 3 months | 3 months |
| change from baseline in uric acid at 1 month | 1 month |
| change from baseline in uric acid at 3 months | 3 months |
| change from baseline in tumor necrosis factor-a at 1 month | 1 month |
| change from baseline in tumor necrosis factor-a at 3 months | 3 months |
| change from baseline in interleukin-6 at 1 month | 1 month |
| change from baseline in interleukin-6 at 3 months | 3 months |
| change from baseline in interleukin-8 at 1 month | 1 month |
| change from baseline in interleukin-8 at 3 months | 3 months |
| change from baseline in fasting insulin at 1 month | 1 month |
| change from baseline in fasting insulin at 3 months | 3 months |
| change from baseline in c peptide at 1 month | 1 month |
| change from baseline in c peptide at 3 months | 3 months |
| change from baseline in visceral fat fraction at 1 month | 1 month |
| change from baseline in visceral fat fraction at 3 months | 3 months |
| change from baseline in body age at 1 month | 1 month |
| change from baseline in body age at 3 months | 3 months |
| change from baseline in percentage of body fat at 1 month | 1 month |
| change from baseline in percentage of body fat at 3 months | 3 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |