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This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group 1 | Placebo Comparator | Group 1 will receive 84 days of placebo BID |
|
| Test Group 2 | Active Comparator | Group 2 will receive 84 days of 0.5 g of BKR-017 BID |
|
| Test Group 3 | Active Comparator | Group 3 will receive 84 days of 1.0 g of BKR-017 BID |
|
| Test Group 4 | Active Comparator | Group 4 will receive 84 days of 1.5 g of BKR-017 BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKR-017 | Dietary Supplement | Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HOMA-IR | Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA | Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fasting low-density lipoprotein-cholesterol (LDL-C) | Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84 | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 |
| Changes in fasting triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Duke Clinical Research at Pickett Road |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002087 | Butyrates |
| ID | Term |
|---|---|
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
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Changes in fasting triglycerides at Days 1, 42, and 84 |
| Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84 |
| Changes in HbA1c | Changes in HbA1c at Days 1, 42, and 84 | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 |
| Changes in fasting glucose | Changes in fasting glucose at Days 1, 42, and 84 | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 |
| Changes in fasting insulin | Changes in fasting insulin at Days 1, 42, and 84 | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Duke Clinical & Translational Science Institute (CTSI) | Kannapolis | North Carolina | 28081 | United States |
| D004700 | Endocrine System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |