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This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | corn starch；capsule，2 g/day，2 times/day；3 months |
|
| Cyclocarya paliurus extract | Experimental | aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months |
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| Cyclocarya paliurus compounds | Experimental | mixed aqueous extract of Cyclocarya paliurus and other traditional Chinese herbal medicines including Astragalus propinquus Schischkin，Dioscorea oppositifolia L.，Dendrobium nobile Lindl.，Salvia miltiorrhiza Bge. and Inulin；capsule，2 g/day，2 times/day；3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclocarya paliurus extract | Dietary Supplement | The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months . |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of FPG | fasting plasma glucose | at 0 week，4th week and 12th week in the intervention period |
| changes of HbA1c | glycated hemoglobin | at 0 week，4th week and 12th week in the intervention period |
| changes of fasting insulin | at 0 week，4th week and 12th week in the intervention period | |
| changes of OGTT | oral glucose tolerance test | at 0 week，4th week and 12th week in the intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| changes of blood lipids | total cholesterol，high density lipoprotein cholesterol，low density lipoprotein cholesterol，triglyceride | at 0 week，4th week and 12th week in the intervention period |
| changes of gut microbiota |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liegang Liu, PhD | Contact | +86-27-83650522 | liegangliu@gmail.com | |
| Hongjie Liu, master | Contact | D201981405@hust.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiyan Taihe Hospital | Shiyan | Hubei | 442008 | China |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
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The allocation of three groups is completed by the primary researcher,and unknown to participants and other reachers. It is the same in the size,color,shape and taste of capsules administrated by three groups.
| Cyclocarya paliurus compounds | Dietary Supplement | The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months . |
|
| placebo | Dietary Supplement | The participants are divided randomly into three groups，one of which are asked to take placebo for three months . |
|
16s RNA sequencing
| at 0 week，4th week and 12th week in the intervention period |
| changes of short chain fatty acids | metabolites of microbiota in feces | at 0 week，4th week and 12th week in the intervention period |