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Research

Diabetes Trials

The main active ingredients in Pro-Z are zinc and bovine prostate substance, which contains high amount zinc, arachidonic acid and Cyclo-(his-pro) (CHP). Several studies have suggested that diabetes is associated with defective insulin degrading enzyme (IDE) production and stimulation of IDE may improve insulin resistance and diabetes. Cyclo-Z (CHP plus zinc) is a stimulator of IDE synthesis. We have examined anti-diabetic activities of Pro-Z and Cyclo-Z in five different animal models:

  1. Streptozotocin-induced diabetic rats (Type 1 model)
  2. Ob/ob mice (Type 2 diabetes with obesity)
  3. Goto-Kakizaki (G-K) rats (Type 2 diabetes without obesity)
  4. Aging Sprague-Dawley rats (naturally induced human insulin resistance-like or mild-Type 2 diabetes)
  5. High carbohydrate fed mice (over eating induced diabetes)

Oral Glucose Tolerance and HbA1c Levels in Type II Diabetic Patients Treated With Pro-Z for 3 Months

Parameter

TAFGC (OGTT*)
(mg • G/dL/h)

HbA1c (%)

Fasting Glucose
(mg/dL)

Pro-Z

Total Group

Before Treatment

140.5 ± 9.2 12.2 ± 0.7 202.2 ± 22.9
After Treatment 101.5 ± 8.0 9.5 ± 0.5 169.2 ± 12.2

Difference

39.0 ± 9.6 2.7 ± 0.6 33.0 ± 21.9
No. of Patients 22 22 22
P .0005 .0003 .14
Responder Group
Before Treatment 141.7 ± 10.3 12.5 ± 0.8 220.9 ± 32.1
After Treatment 94.6 ± 7.5 8.9 ± 0.5 156.1 ± 14.2
Difference 47.2 ± 9.8 3.6 ± 0.6 64.8 ± 28.4
No. of Patients 19 17 15
P .0001 <.0001 .038
Placebo
Beore Treatment 121.2 ± 8.4 10.4 ± 0.8 166.5 ± 12.3
After Treatment 126.4 ± 8.0 10.2 ± 0.6 165.2 ± 11.6
Difference -5.1 ± 9.4 0.2 ± 0.4 1.3 ± 10.4
No. of Patients 18 18 18
P .59 .59 .90

*Oral Glucose Tolerance Test

A FDA approved 3 month clinical trial data showed that human subjects who used Pro-Z which contains various zinc metabolism stimulating agents including arachidonic acid and Cyclo (his-pro) showed significantly improved oral glucose tolerance test (OGTT) (measurement of insulin sensitivity) and decreased Hemoglobin A1c levels (measurement of average blood glucose concentration during the last three months). Urine glucose levels (indication of improved blood glucose control) were significantly decreased, while fasting blood glucose insignificantly decreased (See Research section for published data (Ref 1). In our formal FDA standard phase 1 clinical trial, acute high dose of Cyclo-Z before breakfast in 12 healthy subjects significantly reduced blood glucose levels at 8 hours even after breakfast and lunch (Ref 2). In a pilot efficacy study, postprandial blood glucose levels, Hemoglobin A1c levels, and insulin requirement significantly decreased in 17 out of 18 diabetic subjects during 6 month study. However, the physician noted that the remaining subject showed signs of improvement after more than 7 months of treatment. Some subjects stopped insulin injections completely after the 6 month treatment period. We have finished FDA approved phases 2a clinical trial with excellent results and are moving for Phase2b clinical trials with Cyclo-Z.


Background Studies

Our background studies with animal models indicate that the optimal dose of Pro-Z  (10mg zinc plus 100 mg Prostate extract/L in distilled water) for 3 weeks lowered blood glucose levels 3.45 mmol glucose/L (62.15 mg/dL) and body weight in Streptozocin induced diabetic rats (Ref 6).  Arachidonic acid plus zinc treatment improved insulin resistance and diabetes (Ref 7).   More importantly, optimal dose of Cyclo-Z treatment improved three hour Average above Fasting blood Glucose Concentration (TAFGC)=accurate measurement of OGTT is 0.5 mg CHP plus 10 mg zinc/kg BW for acute treatment. The optimal daily dose for blood glucose lowering rate for 2 weeks is 0.5 mg CHP plus 10 mg zinc/l in the drinking water for genetically diabetic G-K rats, which is equivalent to 0.1 mg CHP plus 2 mg zinc/Kg BW/day based on the calculation of the known amount of CHP and zinc containing water intake per day (Ref 4). Blood glucose levels also significantly decreased in obese ob/ob mice with the same dose (0.1 mg CHP plus 2 mg zinc /kg BW/day) (Ref 5). Therefore, Cyclo-Z dose for the treatment of diabetes must be carefully monitored depending on the need of diabetes treatment. When insulin resistant aged S-D rats were given acute bolus of 1.0 mg CHP plus 10 mg zinc/kg BW, improved TAFGC was maintained at least one week, while the improvement of TAFGC was lost within 24 hours in G-K rats (Ref 8). These data suggest that the blood glucose lowering effect of Cyclo-Z treatment may be more effective and better maintained in obesity induced diabetic subjects. These pre-clinical studies with various animal models and human studies suggest that Pro-Z and Cyclo-Z may be very effective diabetes treatment agents.