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| Name | Class |
|---|---|
| Zhao Hong Biotechnology Co., Ltd. | UNKNOWN |
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The purpose of this study is to determine whether the freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, also evaluate its ability to postpone prediabetes patients to become diabetes.
This study aims to evaluate the effect of freshwater clam extract and its combination is effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability to postpone prediabetes patients to become diabetes., 3 month and 6 month data will be collected and put into analysis to provide some suggestions on the Clam protein capsules and Clam peptide plus Chlorella capsules use in the clinical practice for prediabetes patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The prediabetes patients in this arm will receive Clam protein capsules or Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months. |
|
| placebo | Placebo Comparator | The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clam protein capsules | Dietary Supplement | The prediabetes patients in this arm will receive Clam protein capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the change in lipid profile relative to baseline | Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline | 3 months |
| Assessment of the change in lipid profile relative to baseline | Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline | 6 months |
| Assessment of the change in inflammation index relative to baseline | Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline | 3 months |
| Assessment of the change in inflammation index relative to baseline | Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline | 6 months |
| Assessment of the change in HbA1C (%) relative to baseline | Assessment of the change in HbA1C (%) relative to baseline | 3 months |
| Assessment of the change in HbA1C (%) relative to baseline | Assessment of the change in HbA1C (%) relative to baseline | 6 months |
| Assessment of the change in fasting glucose (mg/dl) relative to baseline | Assessment of the change in fasting glucose (mg/dl) relative to baseline | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TSE-HUNG HUANG, MD PhD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for traditional chinese medicine, Chang Gung Memorial Hospital | Gueishan Township | Taoyuan County | 33378 | Taiwan | ||
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|
| Clam peptide plus Chlorella capsules | Dietary Supplement | The prediabetes patients in this arm will receive Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months. |
|
| Placebo | Dietary Supplement | The prediabetes patients in this arm will receive Placebo with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months. |
|
| Assessment of the change in fasting glucose (mg/dl) relative to baseline | Assessment of the change in fasting glucose (mg/dl) relative to baseline | 6 months |
| Assessment of the change in liver function relative to baseline | Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline | 3 months |
| Assessment of the change in liver function relative to baseline | Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline | 6 months |
| Assessment of the change in renal function relative to baseline | Assessment of the change in Bun(mg/dL),Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline | 3 months |
| Assessment of the change in renal function relative to baseline | Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline | 6 months |
| Assessment of the change in Albumin (g/L) relative to baseline | Assessment of the change in Albumin (g/L) relative to baseline | 3 months |
| Assessment of the change in Albumin (g/L) relative to baseline | Assessment of the change in Albumin (g/L) relative to baseline | 6 months |
| TSE-HUNG HUANG MD PhD |
| Keelung |
| 204 |
| Taiwan |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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