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| Name | Class |
|---|---|
| KAWAMOTO FOODS CO., LTD. | UNKNOWN |
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This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3 placebo capsules/day for 12 weeks |
|
| Ume paste and ginger powder | Experimental | 3 experimental capsules/day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement |
| ||
| Ume paste and ginger powder |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose from baseline | Every 6 weeks (Overall 12 weeks) | |
| Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline | Weeks 0 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline | Weeks 0 and 12 | |
| Change in glycoalbumin from baseline | Weeks 0 and 12 | |
| Change in fasting insulin from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fumiko Higashikawa, PhD | Hiroshima University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiroshima University | Hiroshima | 734-8551 | Japan |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Weeks 0 and 12 |
| Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline | HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405 | Weeks 0 and 12 |
| Change in serum total cholesterol from baseline | Every 6 weeks (Overall 12 weeks) |
| Change in serum LDL cholesterol from baseline | Every 6 weeks (Overall 12 weeks) |
| Change in serum HDL cholesterol from baseline | Every 6 weeks (Overall 12 weeks) |
| Change in serum triglyceride from baseline | Every 6 weeks (Overall 12 weeks) |
| D004700 | Endocrine System Diseases |