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

Introduction

CHARACTERISTICS OF GH/IGF-1 DEFICIENCY

Mental Health

Body Composition

Lipid Profile

Bone Mass

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.

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