Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Greenyn Biotechnology | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to assess the effects of a bitter melon product at two doses, compared to control, on indicators of cardiometabolic health among men and women with prediabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose bitter melon | Experimental | Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg) |
|
| High-dose bitter melon | Experimental | Subject will receive 2 Insumate bitter melon capsules/d (300 mg each) |
|
| Placebo | Placebo Comparator | Subject will receive 2 placebo capsules/d (300 mg each) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose bitter melon | Dietary Supplement | Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Change in HbA1c | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (HbA1c) | Change in HbA1c | Baseline to 6 weeks |
| Fasting glucose | Change in fasting glucose | Baseline up to 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, PhD | MB Clinical Research & Consulting | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excellence Medical & Research | Miami Gardens | Florida | 33169 | United States | ||
| Health Awareness |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39536276 | Derived | Guarneiri LL, Wilcox ML, Kuan CM, Maki KC. Investigation of the Influence of a Bitter Melon Product on Indicators of Cardiometabolic Health in Adults with Prediabetes. J Am Nutr Assoc. 2025 May-Jun;44(4):306-314. doi: 10.1080/27697061.2024.2428301. Epub 2024 Nov 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High-dose bitter melon | Dietary Supplement | Subject will receive 2 Insumate bitter melon capsules/d (300 mg each) |
|
| Placebo | Dietary Supplement | Subject will receive 2 placebo capsules/d (300 mg each) |
|
| Fasting insulin | Change in fasting insulin | Baseline up to 12 weeks |
| Homeostasis model assessment of insulin sensitivity (HOMA%S) | Change in HOMA%S | Baseline up to 12 weeks |
| Homeostasis model assessment of beta-cell function (HOMA%B) | Change in HOMA%B | Baseline up to 12 weeks |
| Total cholesterol | Change in total cholesterol | Baseline up to 12 weeks |
| Low-density lipoprotein cholesterol (LDL-C) | Change in LDL-C | Baseline up to 12 weeks |
| High-density lipoprotein cholesterol (HDL-C) | Change in HDL-C | Baseline up to 12 weeks |
| Non-HDL-C | Change in non-HDL-C | Baseline up to 12 weeks |
| Fasting triglycerides | Change in triglycerides | Baseline up to 12 weeks |
| Body fat | Change in body fat | Baseline up to 12 weeks |
| Skeletal muscle mass | Change in skeletal muscle mass | Baseline up to 12 weeks |
| Port Saint Lucie |
| Florida |
| 34952 |
| United States |
| Biofortis, Inc. | Addison | Illinois | 60101 | United States |
| D004700 | Endocrine System Diseases |