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| THE ROLE OF CHOLINERGIC DERIVATIVES AS HORMONE hGH SECRETAGOGUES |
 G.P.Ceda.G Ceresini.L. Denti, G Marzani, E Piovani, A Banchini, E Tarditi, G valenti, Chair of Gerontology and Geriatrics, University of Parma, Italy.December 29 , 2000 Background The consistent study of the effects of DNA recombinant human growth hormone injections on human subjects has demonstrated favourable changes in body composition, improved immune system, elevation of energy and recuperative abilities, improved sexual functions and mental cognition. Based on individual dosages, administration protocols and frequency of administration, side effects observed on individual dosages, administration protocols and frequency of administration, side effects observed were down regulation of endogenous GH production, oedema, carpal tunnel syndrome and increase in allergies and inflammatory responses. These has led to a more detailed investigative study for an alternative method of increasing serum GH levels and its active metabolite, IGF-1 in human subjects.
The purpose of this research is to assess the viability and effectiveness of proprietary cholinergic derivatives (L – Alpha Glycery IPhosphoryl Choline) and other peptide based substances as a food based GH secretagogue to stimulate the release of GH / IGF-1 in humans.
Abstracts Over a period of 20 weeks, 30 individuals (age 48 – 70 )with low levels of Insulin – like Growth Factor Type 1 (IGF-1 <350ng/ml),were clinically assessed in terms of existing prevailing and observed medical symptoms. Individual serum IGF-1 baseline figures were established while subject were administered Somatoplex Sublingual liquid spray, a combination of a bio-available form of choline (L – Alpha GlyceryIPhosphoryl Choline) and broad spectrum growth factors devived from dairy sources (whey and egg yolk extract). Beta- lactoglobulin has been removed from all dairy sources to prevent milk allergies. Using non invasive saliva assays, an average of 34% increase in serum IGF-1 was observed among subjects. Subjects reported an improvement in sleep quality, cardiovascular endurance, body composition, skin condition, sexual function, recuperative abilities, immunity, and mental function. Additional clinical observations were improvements in joint pain, insulin sensitivity, blood pressure and blood glucose management.
Introduction Hgh is produced by somatotropes in the anterior pituitary gland. Its release is governed by GHRP (growth hormone releasing peptides) and Somatostatin ( inhibitor ).
It is well established from Rudman’s study that the release of Hgh declines with age due to a decline in GHRP and an increase in the inhibitor, Somatostatin. The use of cholinergic substances such as L- Alpha Glycerylphosphoryl Choline have been clinically proven to increase the amplitude and frequency of growth hormone release within physiologic boundaries by decreasing Somatostatin and increasing GHRP. GH has a half life of 20 minutes and is converted at the liver to its immediate active metabolite, a growth factor termed as IGF – 1(insulin like growth factor – 1) which will remain in the bloodstream with a longer half life of 20 hours. It is IGF -1 which provides all benefits experienced by the subjects. Rudman established that IGF-1 is a more stable and reliable marker of GH levels in humans. CHARACTERISTICS OF GH/IGF-1 DEFICIENCY Mental Health Reduced sex drive
Emotional instability Poor memory and concentration Depression Lack of social interaction Lack of purpose Reduced energy Body Composition Reduced lean body mass and/or skeletal muscle mass Reduced skeletal muscle strength Reduced exercise performance Increased total body fat Increased abdominal and visceral fat
Lipid Profile Decreased HDL cholesterol
Elevated apolipoprotein Elevated LDL cholesterol Bone Mass Osteopenia (lack of bone)
Metabolic Effects Reduced T4 to T3 conversion Insulin resistance (in obese people) Hypoglycemia Possible abnormal resting metabolic rate Skin condition Decreased nail and hair growth Thin skin Lack of collagen Decreased size of organs Dehydration Reduced glomerular filtration and renal plasma flow Reduced sweating – inability to thermo-regulate Reduced cardiac output (potentially) Increased vein resistance Factors that govern the release of GH and IGF-1, including somatostatin, insulin, somatotroph receptors, GHRH, hepatic function , and sensitivity of IGF -1 receptor sites. Pharmacologically correlating these factors with the action of L- Alpha Glycerylphosphoryl Choline, a bio-available form of broad spectrum growth factors has lad to the development of Somatoplex sublingual hGH secretagogue, a promoter of GH release and IGF-1. Clinically, the efficacy of Somatoplex Sublingual has been evaluated through IGF-1 measurement and patient self-assessment. Method 30 patients, 15 women and 15 men, aged between 48 and 70, were selected for this study based on their baseline IGF-1 lavels which showed a deficiency in GH. Initial IGF-1 measurements ranged from 28 to 260 ng/ml. Every subject was instructed to consume Somatoplex Sublingual,3 times a day in the morning, afternoon, and prior to retiring. This schedule was maintained in a five-day one, two day off cycle for a term of 20 weeks. Baseline figures were collated before the administration of Somatoplex Sublinguals. First reading was made on the fourth week and then at four week intervals for 20 weeks in combination with physical examinations once every week. Results Within the first 4 weeks, 80% of all patients reported improved sleep, cognitive abilities physical endurance, mental well- being and sexual function. Improvements in skin condition, were observed to start week 8 right through week 20. Improvements in insulin sensitivity and reduction of blood pressure started at week 8 through week 20. No side effects were observed that could be attributed to Somatoplex Sublingual. Measurements indicate continued increases in IGF-1 throughout the 20 week term. A twenty week term indicated a 34% spread over the entire range of age group. This increase was noted to produce visible beneficial effects. Conclusion Somatoplex Sublingual was observed clinically to increase the levels of GH and IGF-1 in humans and provide most benefits accruing to synthetic GH injections as proven by Rudman Somatoplex Sublingual’s therapeutic potential in the improvement of insulin resistance, rheumatism, pulmonary disorders, obesity, and chronic fatigue syndrome (CFS), would warrant further epidemiological studies in these specific areas of interests. REFERENCES Abbati,C Rondi, G, Rosola,R, Vavarori, F., Bierich JR. Multi-center clinical trial of authentic recombinant somatropin in growth hormone deficiency. Acta Paediatr Scand Suppl. 1987;337:135-140. Ho KY, Evans WS, Blizzard RM, et al. Effects of sex and age on the 24 hour profile of growth hormone secretion in man: importance of endogenous estradiol concentrations. J Clin Endocrinol Metab 1987;64:51-58. Hall K, Sara VR. Somatomedin levels in childhood, adolescence and adult file. J Endocrinol Metab 1984;13:91-112. Meites J.Neuroendocrine biomarkers of aging in the rat. Exp Gerontol 1988;23:349-58. Finkelstien JW, Boyar RM, Roffwarg HB, Krean J, Hellman L. Age-related change in the twenty-four- hour spontaneous secretion of growth hormone. J Clin Endocrin Metab 1792; 35:665-70. Clemmons DR, Van Wyk JJ. Factors controlling blood concentrations of somatomedin C. Clin Endocrinol Metab 1984;13:113-43. Florini JR, Prinz PN, Vitiello MV, Hintz RL. Somatomedin C levels in healthy young and old men : relationship to peak and 24-hour integrated levels of growth hormone. J Gerontol 1985;40:2-7. Jorgenson JOL, Pedersen SA, Thuesen L, et al. Beneficial effects of growth hormone treatment in GH-deficient adults. Lancet 1989;1:1221-5. Salomon F, Cuneo RC, Hesp R, Sonksen PH. The effects of treatment with recombinant growth hormone on body composition and metabolism in adults with growth hormone deficiency. N Engl J Med 1989;321:1797-803. Van der Werff ten bossch JJ, Bot A, Effects of human pituitary growth hormone on body composition. Neth J Mrd 1987; 30: 220-7. Crist Dm, Peake GT, Mackinnon LT, SIbbit WL Jr, Kraner JC. Exogenous growth hormone treatment alters body composition and increases natural killer cell activity in women with impaired endogenous growth hormone secretion. Metabolism 1987;36:1115-7.
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Effects of growth hormone on insulin action in man: mechanisms of insulin resistance, impaired suppression of glucose production, and impaired stimulation of glucose utilization Novak LP. Aging, total body potassium, fat-free mass, and cell mass in males and females between the ages of 18 and 85 years. J Gerontol 1972;27:438-43.
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