Preventive Nutrient Company

PRODUCT INDICATIONS AND GUIDELINES


Indications of Pro-Z and Glucometa (Cylco-Z)

Pro-Z  was the first patented product for the treatment of diabetes 

(US patent Nos. 5,411,748 approved on May 2, 1995 and 5,834,032 

on December 9, 1999).  After the initial study with the animals, 

Dr. Song and his colleagues have performed the first clinical trial 

with FDA Initial New Drug (IND) clinical trial approval with 

IND No. 48,348 on December 28, 1995  and VA Institutional 

Review Board (IRB) approval.  The experimental results published

 in 1998 (Song, MK, et al. Metabolism 47:39-43, 1998) and are 

briefly described as follows:


Table 1.  Improved OGTT and Hemoglobin A1C levels in Type II 

Diabetic Patients Treated with Pro-Z Capsules for Three Months

                                        

Parameter

TAFG (OGTT)

(mg.G/dl/hr)

Hemoglobin A1C values (%)

Fasting Glucose Levels

(mg/dl)

Pro-Z Treated Group

 

 

 

 

 

 

 

Total Group

 

 

 

Before treatment

140.5 + 9.2                      

12.2 + 0.7                           

202.2 + 22.9                                            

After treatment

101.5+ 8.5                        

9.5 + 0.5                          

169.2 + 12.2                                     

Difference

39.0 + 9.6                                

3.1 + 0.8                             

38.3 + 31.2                                              

No. Patients

22

22

22

P-values

0.0005                                      

0.0003                                  

0.14

 

 

 

 

Responded 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. Patients

19

17

15

P-values

0.0001                                     

0.0001                                  

0.038

 

 

 

 

Placebo Group

 

 

 

Before 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. Patients

18

18

18

P-values

0.59                                         

0.59                                         

    0.90


Oral glucose tolerance test  (OGTT) is a measurement of clinical 

improvement of diabetes. P values smaller than 0.05 is indication 

of statistically significant improvement of diabetes control.   


Forty five diabetic patients not treated with insulin were assigned 

randomly either A (Placebo) or B (Pro-Z) labeled bottle.  Five 

patients did not complete the study by not complying with 

instruction. 


We have recently applied for a new Pro-Z patent application for the

treatment of Prostate hyperplasia.  Pro-Z worked better than any 

other existing prostate hyperplasia treatment drugs in our animal 

studies. Although we have not performed clinical trial for the FDA 

approval, we would like to  recommend Pro-Z for those who have 

prostate hyperplasia to try our Pro-Z products in addition to the 

treatment of diabetes. There was essentially no side effects. 

However, patients with inflammatory pain need to monitor.                                                                                                                                                     

 

Cyclo-Z

 

Cyclo (his-pro) (CHP)is a thyrotrophin-releasing hormone (TRH) 

metabolite, which is synthesized in the cell.  It is present in almost 

all of the body organ cells and in the protein food sources such as 

milk, soybean protein hydrolysates, and sea food such as shrimp, 

oyster etc.  Its biological role is not clearly established, but no side 

effects were shown when taken minute amounts (3-15 mg/day) of 

CHP in humans.  Since it is an endogenous dipeptide, CHP is not 

considered a toxic chemical even if taken in gram levels per day. 

Zinc is known as an essential nutrient with RDA 15 -20 mg/day 

without showing any side effects when taken less than 80 mg/day. 

Chromium is also considered as an essential trace element for 

maintaining health.  Thus, all the chemicals and active ingredients

listed in the Cyclo-Z are food ingredients, and the amounts of these

constituents in the Cyro-Z are far less than toxic levels. We have 

demonstrated it in humans after the FDA approval followed by 

VA IRB approval.  The results showed no side effects at all when 

high doses of these chemicals are ingested by humans which data

are published in December 31, 2010( Uyemura K. et al.  J Drug

Metabol Toxicol   1:105 (Pages 1-9), 2010).  Therefore, regular 

intake of Cyclo-Z capsules should improve many human health

problems without posing any side effects.

 

After the VA Institutional Review Board approval on June 1, 2009, 

we initiated  a formal Phase 2a clinical trial at the VA Greater

Los Angeles Healthcare System. A physician in China performed an

informal clinical trial.                                                      

 

Parameter
TAFG (OGTT)
(mg.G/dl/hr)
Hemoglobin A1C values (%)
Fasting Glucose Levels
(mg/dl)
Pro-Z Treated Group
 
 
 
 
 
 
 
Total Group
 
 
 
Before treatment
140.5 + 9.2                      
12.2 + 0.7                           
202.2 + 22.9                                            
After treatment
101.5+ 8.5                        
9.5 + 0.5                          
169.2 + 12.2                                     
Difference
39.0 + 9.6                                
3.1 + 0.8                             
38.3 + 31.2                                              
No. Patients
22
22
22
P-values
0.0005                                      
0.0003                                  
0.14
 
 
 
 
Responded 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. Patients
19
17
15
P-values
0.0001                                     
0.0001                                  
0.038
 
 
 
 
Placebo Group
 
 
 
Before 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. Patients
18
18
18
P-values
0.59                                         
0.59                                         
    0.90

During these treatment periods, hemoglobin A1C levels decreased from mean

value 7.5%  to 5. 8%, and insulin doses from 27.33 units to 6.67

units.  We have initiated Phase 2 clinical trial at the VA Greater Los 

Angeles Healthcare System in 2009 with VA Merit Review fund.  

The study subjects are essentially near insulin resistant and very 

mild diabetic subjects without other anti-diabetes drug treatment.  

Thus, the differences are not very different or very significant.  

However, it shows the trend of improving diabetes but very 

significantly with obese subjects.  The enrolled study patients were

only 37 subjects and only 28 subjects finished the study.  Out of 28 

subjects. 18 subjects had average above 6.9 % of HbA1c and

finished the 12 week study duration.  The optimal daily dose of 

Cyclo-Z is 6-9 mg CHP plus 20 mg zinc  depending on the body

weight of the subjects as determined in animal models and this 

clinical trial data.  

 

Cyclo-Z (Glucometa) did not pose any side effect in our human toxicity study.  

However, we recommend to take 3 mg CHP plus 20 mg zinc 

capsules  2 or 3 capsules per day before 30-60 minutes each meal

or before bed time .