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SOMASTATIN Clinical Study


Somatostatin Inhibitor, Endogenous HGH Potentiator, Oral Endocrine Support and ACTH Testosterone Booster



~ Clinical Study ~
Published March 21, 1999

Research Director:

Dr. Dean Friesen, Pharm. D.

Calvin Ross, D.C., B.E.C.O.


Test conducted at:

Life Center for Health

San Clemente, CA


Laboratory analysis conducted at:

Aeron Life Cycles Clinical Laboratory

San Leandro, CA


Unilab (Serum Laboratories)

Mission Viejo, CA


BACKGROUND:

It is becoming increasingly clear that there is a growing interest in the arena known as "anti-aging sciences." At the center of this, is the interest in hormone re-stimulation as opposed to replacement in the aging patient. Testosterone, DHEA, Somatotropin (Human Growth Hormone or hGH) and related hormones are heavily studied. The effects of these hormones on the body have been well documented. Major studies have shown that as we age our production of many youth preserving hormones decrease. This decrease often leads to the symptoms we have come to call "aging or senescence". These same studies have shown that by administering these hormones to patients through injections or other exogenous administration, many of the age related symptoms are reversed. The most significant tools in the anti-aging battle are by far human growth hormone and testosterone replacement in men and estrogen/progesterone replacement in women; however, the high cost places these therapies far beyond the reach of the majority of the aging population.

There is a growing public interest for a safe, effective way to continue receiving the benefits of the body's own beneficial hormone production. SOMASTATIN was developed in answer to this growing need. The data presented below shows SOMASTATIN to be a viable alternative to conventional and costly hormone replacement therapies. SOMASTATIN has been in development for a almost a half a decade and functions by receptor site peptide affinity, wherein amino acids are specifically sequenced to mimic the molecular structure of the body's own hormone-releasing peptides.


HYPOTHESIS:

There are several known factors that act directly upon endogenous hormone release; the majority of these factors are themselves peptide hormones. Inspired by the growing body of scientific data, SOMASTATIN was launched from the premise that certain mimetic peptide combinations would have stimulatory effects similar to those caused by the body's own peptide hormones and would prove effective in significantly increasing the endogenous secretion of youth preserving hormones. Specifically, hGH, DHEA and testosterone. The growing body of clinical evidence also suggests that mild suppression of soma to statin also contributes to increased hGH production and utilization. In light of the foregoing, a preparation of this type would lower or eliminate he need for costly hormone replacement therapy in age-deficient subjects.


PURPOSE:

Clinically measure the chemical and physiological response to SOMASTATIN when administered through the oral mucosa; determine the level of target hormone response by specific bio-marker testing; determine the effectiveness of the Biodegradable Microsphere technology employed by SOMASTATIN as a viable mechanism for delivery of this supplement; to verify that no significant rise in IGF-1 results from supplementation with SOMASTATIN.


SUBJECTS:

Fifteen (15) test subjects.

•  10 Male

•  5 Female

•  Subjects represent an average cross-section of individuals between the ages of 45 to 75

•  Subjects received one 30ml spray bottle of SOMASTATIN and were instructed to administer one (1) spray per thirty (30) pounds of body weight: one half the daily dosage was administered upon rising and one half the daily dosage was administered upon retiring to sleep. (Each spray contains approximately 0.174 ml, or approximately 172 sprays per bottle)


PROCEDURES:

Test subjects were specifically instructed not to alter their lifestyle in any way during the six-week test period. The only lifestyle change was for each test subject to take the test supplement SOMASTATIN, a soma to statin inhibitor. Transmucosal administration with SOMASTATIN and testing using standard clinical tests including blood chemistry analysis, urine chemistry analysis, saliva chemistry analysis, blood pressure, body fat percentage and strength were conducted on test subjects to determine the effectiveness of soma to statin inhibition in raising human growth hormone production.

Blood, urine and saliva panels were drawn on all subjects upon commencement of the test to determine individual baselines before any SOMASTATIN test product was supplied to the test subjects. Initial blood work was drawn on the same day that the subjects began the six-week test regimen. The following clinical tests were administered under controlled conditions within the doctor's practice and the established independent laboratories named above.


Blood Panel Consisted of:

•  IGF-1

•  Cholesterol

•  HDL

•  LDL

•  Glucose


Saliva Panels Consisted of:

•  DHEA

•  Testosterone

•  Progesterone

•  Cortisol

•  Estrodiol


Urinalysis Panels Consisted of:

•  Glucose

•  Bilirubin

•  Ketone

•  Specific Gravity

•  Blood

•  PH

•  Protein

•  Urobilingen

•  Nitrite


Other clinical measurements taken:

Grip Strength with Jamar Dynametor

Anaerobic Threshold with Stationary Bench Press

Blood Pressure with biceps blood pressure cuff

Body Fat Percentage

Pounds of Lean Body Mass

Pounds of Body Fat


STUDY RESULTS:

The following results were observed and documented and are an average mean value of the fifteen (15) subjects who remained in the test through six (6) weeks.

DHEA +40.81%

Testosterone: +22.86

Anaerobic Threshold +14.75%

Grip Strength +29.90%

Lean Body Mass +2.96%

Body Fat Percent -7.24%

Blood Pressure (diastolic) -7.49% (drop 10 points in six weeks)

Cortisol Baseline (avg.): 1.68 ng/ml. At six weeks (avg): 4.1125 ng/ml (Referential range: 1.0 - 8.0 ng/ml: saliva)

Estrodiol -4.52%

Progesterone no change

Glucose no change

HDL +58.06%

LDL +1.29%

Cholesterol +7.17%

IGF-1 +1.12%

Urine Analysis improved Biliruben and Urobilingen profiles


OTHER NOTED IMPROVEMENTS:

•  Sleep (improved) - 5 subjects

•  Less Urination at Night - 3 subjects

•  Short Term Memory (improved) - 7 subjects

•  Smoother & More Youthful Skin - 3 subjects

•  Aches & Pains dissipated - 4 subjects

•  Hair color/texture restoration - 5 subjects

•  Sinus Improvement 2 - subjects

•  Improved Hearing 3 - subjects

•  Increased Immunity 3 - subjects

•  Liver Spots improved (lipofusion) - 3 subjects

•  Bowel Movement - 4 subjects

•  Improved Well Being/Energy - 8 subjects


ADDITIONAL NOTATIONS

Atrial cardiac arrhythmia dissipated - 1 subject

Human Parvo symptoms alleviated - 1 subject

Accelerated Wound Healing - 4 subjects

Improved Muscle tone - 10 subjects

Increased sexual stamina 4 - subjects

Increased sexual performance 4 - subjects

Increased libido 4 - subjects


CONCLUSION:

This study documents the effectiveness of SOMASTATIN as an adjunct to anti-aging therapy where reversal of the clinical symptoms of aging is desired. SOMASTATIN has been shown to be a safe and efficacious single alternative, and as an adjunct to rHGH injection and other hormone therapy. The ability for SOMASTATIN to improve life-extension biomarkers without significantly raising IGF-1 has also been documented in this study and is an important detail to be considered. Biodegradable Microsphere technology has also been shown to be a viable nutrient delivery system for the SOMASTATIN product. Further study is recommended to determine the effects of SOMASTATIN as a long-term, anti-aging therapy.


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REFERENCES:

Harvey S, Scanes CG, Somatostatin inhibition of growth hormone secretion in an adult bird: the domestic fowl. Comp Biochem Physiol A 1987;87(2):315-8.

Rene E, Willoughby J, Brazeau P. Differentiation between the somatostatin inhibition and the post-somatostatin rebound observed on growth hormone secretion in vitro. Regul Pept 1982 Nov;4(6):325-31.

Rudman, D, et al. Effects of Human Growth Hormone in Men Over 60 Years Old. New Engl J Med 1990:323 .

Prof. Dr. Merkle, Hans P. et al. Biodegradable Polyester Microspheres for Controlled Drug and Vaccine Delivery. ETHZ Research Project.

Brown, J.; Garraugh, G; Parkinson, T.; Wingard, R.; Onderdonk, A, Journal of Medicinal Chemistry, 1983, 26, 1300- 1307.

Dressman, J; Bass, P.; Ritschel, W.; Friend, D.; Rubinstein, A.; Ziv, E., Journal of Pharmaceutical Sciences, 1993, 82, 857Ñ872.

Hilton, A. and Deasy, P., Journal of Pharmaceutical Sciences, 1993, 82, 737-743.

Langer, R., Science, 1990, 249, 1527Ñ1533.

Saffran, M; Kumar, G.; Savariar, C.; Burnham, J.; Williams, F.; Neckers, D., Science 1986, 233, 1081- 1084

Langer, R., Accounts of Chemical Research, 1993, 26, 537-542.

Supersaxo, A.; Kou, J.; Teitelbaum, P.; Maskiewicz, R., Journal of Controlled Release, 1993, 23, 157Ñ164.

Swarbrick, J. and Boylan, J. (ed). Controlled- and Modulated-Release Drug-Delivery Systems. Encyclopedia of Pharmaceutical Technology. Marcel Dekker, Inc, 1990.


 

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