A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
| Status: | Archived |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
| End Date: | August 2011 |
A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
The purpose of this clinical research study is to evaluate the effects an investigational
food product has on the blood sugar and insulin levels in individuals with diabetes.
The investigational product has helped decrease the amount of insulin needed in treating
diabetic dogs and has improved the dogs' longevity and quality of life. Observational
analysis by trained veterinarians has indicated that the natural fluctuations in blood
glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested
the product in a brownie form. The product has been reformulated to capsule form for the
Phase 2 study.
The hypothesis for this study is that diabetic individuals will decrease their
insulin/diabetic medication usage and have a decrease in glucose levels after consuming the
product for 16 weeks.
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