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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. The study consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| herb and mineral combination product | Active Comparator | Subjects will consume 3 herb and mineral combination product softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period. |
|
| placebo | Placebo Comparator | Subjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| herb and mineral combination product | Dietary Supplement | herb and mineral product containing cinnamon, turmeric and holy basil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in fasting blood glucose | Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84 | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in fasting serum glucose | Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42 | Day 42 |
| Change from Baseline in fasting blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Chicago | Illinois | 60610 | United States | ||
| Central Kentucky Research Associates |
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| Placebo | Dietary Supplement | Placebo of herb and mineral product containing cinnamon, turmeric and holy basil |
|
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21
| Day 21 |
| Change from Baseline in HbA1c | Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84. | Day 84 |
| Change from Baseline in fasting lipids | Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 84 using a standard lipid panel. | Day 84 |
| Change from Baseline in fasting lipids | Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 42 using a standard lipid panel. | Day 42 |
| Change from Baseline in fasting lipids | Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 21 using a standard lipid panel. | Day 21 |
| Change from Baseline in BMI | Body mass index | Day 84 |
| Change from Baseline in waist-to-hip ratio | Day 84 |
| Lexington |
| Kentucky |
| 40509 |
| United States |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | United States |
| Radiant Research | Cincinnati | Ohio | 45249 | United States |
| Providence Health Partners Center for Clinical Research | Dayton | Ohio | 45439 | United States |
| Mountain View Clinical Research | Greer | South Carolina | 29651 | United States |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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