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BioProtein+PlusTM Proof of Concept Open Label Pilot Study

Summary

Thirty-five people, each symptomatic and clinically positive for Hepatitis C infection, and displaying elevated AST & ALT Liver enzymes and RNA PCR Viral counts, were tested at regular intervals over a six month period, to determine any changes in these values, while taking one packet of BioProtein+PlusTM per day. Other inclusion criteria were: no significant co-infection and no other current treatment for Hepatitis C was permitted or given. Of the thirty-five people enrolled, twenty-seven completed the trial and the data gathered was statistically analyzed. Twenty-five of the participants reported significantly increased energy levels and a much-improved feeling of overall wellness. Five participants demonstrated no clinical improvement.

Overall the study results were highly significant and the p-value indicates that the results were not due to chance alone or due to experimental effects.

Introduction

Hepatitis C has an incubation period of 15 to 150 days before the onset of clinical symptoms. Early symptoms are commonly fatigue and jaundice. The majority of cases, even those that develop chronic infection, are asymptomatic. In 60 to 70 percent of infections, 10 to 20 years may pass between infection and the onset of symptoms. Once symptomatic, the virus can cause deterioration of liver function, cirrhosis, and liver cancer and may be a pathway for opportunistic co-infection. There are perhaps 3-4 million people diagnosed with Hepatitis C in the United States and maybe that many more not yet diagnosed because of the long latency period. World wide it is estimated that as many as 170 million people are infected.

Antiviral drugs are available for treatment. People with chronic Hepatitis C can use interferon taken alone or in combination with Ribavirin. Ribavirin does not appear to be effective alone, Interferon by itself, is about 10 to 20 percent effective, and in combination with Ribavirin, it is effective in 30 to 50 percent of cases.

BioProtein+PlusTM is a unique nutritional supplement containing biologically active thymic proteins ranging in atomic weight from 10,000 to 50,000 Daltons, plus zinc gluconate. Thymic proteins have been shown to stimulate mature lymphocytes and enhance a cell mediated, highly specific immune response to virus. The proteins contained in BioProtein+PlusTM are purified from calf thymus and triturated with the zinc gluconate into a base of Maltodextrin, then sealed in packets containing approximately 400 mg. of product. BioProtein+PlusTM is available over the counter in boxes of 30 packets and is taken one packet per day, or as recommended by a health care practitioner.

RNA PCR measurements are commonly used to diagnose Hepatitis C, and elevated ALT and AST liver enzymes are common symptoms of active Hepatitis C infection. The purpose of the study was to determine if BioProtein+PlusTM has biological activity by demonstrating a cell mediated immune response as measured by a reduction in RNA PCR and concurrent reductions in ALT and AST levels in Hepatitis C infected people.

Methods

This study was conducted as a Proof of Concept- Open Label Pilot Study only. Thirty-five people meeting the inclusion criteria were recruited from the customer base of BioActive Research, the manufacturers of BioProtein+PlusTM to participate in the study for six months. Each volunteer was supplied enough product to take one packet per day at no cost. Each participant was required to obtain a baseline, 3 month and 6 month blood test measuring AST, ALT and RNA PCR from their regular health care provider. The blood test results were transmitted to BioActive Research for compilation and statistical analysis. AST and ALT levels were tested before treatment and at 3 and 6-month intervals, RNA PCR levels were measured before treatment and at 6 months.

The participants were not otherwise monitored and were requested to forego any other Hepatitis C treatment during the six-month study period.

Results

Of the thirty-five participants enrolled, twenty-seven completed the study. No one reported any adverse side effects. The accompanying table and graphs illustrate the statistical significance of the reductions in AST, ALT and RNA PCR. Although this was a non-blinded pilot study, the purpose of the exercise was to demonstrate that BioProtein+PlusTM is a biologically active product that can stimulate cell mediated immunity. The accompanying analysis indicates highly statistically significant reductions in serological categories with 99 % likelihood that the results were achieved by the treatment and not by chance or due to experimental effects.

 
AST
3 mo.
6 mo.
ALT
3 mo.
6 mo.
RNA PCR
6 mo.
Mean
83
57.888
44.148
108.222
74.529
56.407
38763
23200
Ste. Dev.
23.42
32.543
24.013
29.855
30.648
34.855
21.193
23677
Differences from baseline conditions, df=26
Mean
-25.111
-38.851
-33.629
-51.815
-15562
Ste. Dev.
19.721
16.256
21.294
26.76
2143
Std. Err.
3.795
3.128
4.098
5.149
2337

Mean IU/L Over Time Individual AST IU/L Over Time
Individual ALT IU/L Over Time Individual RNA OCR Quantity Over Time


References

  1. Naylor PH, Mutchnick MG. Thymus derived peptides in the treatment of viral chronic hepatitis. Dig. Dis. Nov-Dec;14(6): 362-70.
  2. Kouttab NM, Prada M., Cazzola P. Thymomodulim. Biological properties and clinical applications. Med Oncol Tumor Pharmacother 1989; 6: 5-9.
  3. Cazzola P, Mazzanti P, Bossi G. In vivo modulation effect of a calf thymus acid lysate on human T Lymphocyte subsets and CD4+/CD8+ ratio in the course of different diseases. Curr Ther Res 1987; 42: 1011-1017.
  4. Eaterbrook-Smith S. Activation of the binding of C1q to immune complexes by zinc. FEBS Lett 1983; 162: 117-119.
  5. Hadden JW. The treatment of zinc deficiency in immunotherapy. Int J Immunopharmac 1995; 17: 697-701.

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Note: This material is intended for educational purposes only, and should not be used as a substitute for the advice of a qualified health professional. Statements about the use of any products referred to herein have not been evaluated by the FDA, nor are these products intended to prevent or treat any disease.