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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
7 capsules taken 15 minutes before each of the three main meals of the day
Avera Research Institute
Sioux Falls, South Dakota, United States
Blood Sugar
blood sugar levels
Time frame: 16 weeks
HgA1c reduction
reduction of Hemoglobin A1c levels
Time frame: 16 weeks
Diabetes medication
reduction in the amount of diabetes medication needed
Time frame: 16 weeks
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