Randomized Study of Oral Spray GH in Patients Between 35 to 80 Years of Age 4000 ng per day Growth Hormone (GH) Sublingual Spray Polymer Matrix Delivery System

ABSTRACT:

This phase II study will evaluate the effectiveness of oral spray GH and its efficacy for cellular regeneration.

PURPOSE:

Objectives:

1. Clinically evaluate an assisted six-month study involving the administration of a polymer matrix oral spray GH delivery system.

2. Assess IGF-1, triglyceride, HDL and LDL levels for patients 35 to 80 years of age from an individual’s baseline to maximum applicable change over a period of 6 months.

STUDY TYPE:

Clinical.

FURTHER STUDY DETAILS:

PROTOCOL OUTLINE

This is a randomized, double blind study. Prior to randomization each patient must be subjected to a two-week wash out period wherein no nutritional vitamins & supplements, alcohol, tobacco, are used.  Patients will fast without exercise for eight hours prior to serum tests, which will include IRB study protocols, IGF-1, HDL, LDL, triglycerides, liver enzymes, and kidney enzymes. 

Patients are randomized to receive either placebo or Oral Spray GH sublingually every day, three sprays in the morning upon awakening and three sprays in the evening prior to bedtime for 6 months. Patients will undergo serum testing to establish individual baselines. Replicated testing periods are 30 days, 60 days and 180 days.

PROJECTED ACCURAL:

A total of 200 patients will be accrued for this study. Random ages with the bulk above 50 years.  50/50 male and female with average to fair health.

ELGIBILITY:

Ages eligible for Study:  35 Years to 80 years

PROTOCOL ENTRY CRITERIA:

Patient characteristics:

Reasonable health without progressive unintentional weight loss/gain more than 2.5% of the initial or ideal body weight and/or patient does not weigh less than 90% of ideal body weight.

Biochemical parameters of nutrition defined by two or more of the following measurements over the past 3 months: Serum albumin no less than 3.7 g/dL. Serum transferrin concentration more than 200 mg/dL. Serum prealbumin concentration more than 30 mg/dL .Serum IGF-1 concentration more than 0.250 mg/mL

Hepatic & Renal:

Assess Liver and Kidney enzymes on all study participants to insure zero degradation in healthy organs during testing procedures.

Autoimmune:

No active autoimmune, inflammatory, or infectious disease at least 6 months prior to test.

Diet

No unusual dietary restrictions at least 3 months prior to test.

SUMMARY:

200 healthy patients were screened and tested (112 females and 88 males). No change in diet was advised, however it was noted that all patients ate an average of 3 meals per day with approximate intakes of 3000 to 4000 calories.

Testing began with a prescribed dosage of 3 sprays in the morning within one hour of awakening (equaling 2000ng of hGH) and 3 sprays in the evening immediately before retiring (totaling 4000ng of hGH per day) seven days per week.

IGF 1 testing is presently the standard accepted procedure for evaluating the secretion of human growth hormone from the anterior pituitary gland. Patients were pre-examined as to determine a baseline IGF 1, 114.26 ng/ml (+/- 8.54) in 112 females (average age 51) and 135.22 (+/- 1.94) in 88 males (average age 48). 30 days after test inception, non-placebo female patients showed IGF 1 levels elevated 30 percent over baselines, 149.85 ng/ml females and 176.31 ng/ml non-placebo males. IGF 1 levels were tested after 60 days and again displayed elevated increases now 53 percent over baselines, 175.63 ng/ml females and 209.59 ng/ml males.  At the end of the six-month study, IGF 1 levels had increased over 102 percent over baseline in females (232.12 ng/ml) and 109 percent over baseline in males (284.05 ng/ml).

Patients on placebo incurred dramatically different results. 30 days after inception, female/male patients IGF 1 levels were elevated or lowered +/- 2 percent over/under baselines. IGF 1 levels were tested after 60 days and again displayed in average, 4 percent over baselines.  At the end of the six-month study, IGF 1 levels in placebo patients averaged less than 3 percent increase over baseline.

Patients were pre-examined to determine a baseline HDL level, 36 mg/dl in females and 28 mg/dl in males.  30 days after test inception, testing non-placebo female patients, HDL levels were 42 mg/dl and non-placebo males were 34 mg/dl. HDL levels were tested after 60 days and again displayed elevated increases over baselines, 49 mg/d/ females and 48 mg/dl males.  At the end of the six-month study HDL levels had increased over 47 percent over baseline in females (53 mg/dl) and 93 percent over baseline in males (56 mg/dl).

Patients were pre-examined to determine a baseline LDL level, 172 mg/dl in females and 161 mg/dl in males.  30 days after test inception, testing non-placebo female patients, LDL levels were 169 mg/dl and non-placebo males were 152 mg/dl. LDL levels were tested after 60 days and again displayed reduced levels over baselines, 154 mg/d/ females and 141 mg/dl males.  At the end of the six-month study LDL levels had decreased over 20 percent under baseline in females (137 mg/dl) and 23 percent under baseline in males (124 mg/dl).

Patients were pre-examined to determine a baseline triglyceride level, 201 mg/dl in females and 182 mg/dl in males.  30 days after test inception, testing non-placebo female patients, triglyceride levels were 166 mg/dl and non-placebo males were 152 mg/dl. Triglyceride levels were tested after 60 days and again displayed marked decreases over baselines, 144 mg/d/ females and 133 mg/dl males.  At the end of the six-month study, triglyceride levels had decreased over 40 percent under baseline in females (121 mg/dl) and 35 percent under baseline in males (119 mg/dl).

Patients on placebo incurred dramatically different results. After the final test period of 180 days, cholesterol and triglyceride levels showed insignificant changes.

Liver and kidney enzymes (ALT, SGOT, SGPT) were measured at baseline, 30, 60 and 180 days. The placebo and test group both indicated normal values throughout the testing period with no notable fluctuation. Parathyroid Hormone (PHT) was also measured at each testing and remained normal in both the placebo and test group at each measurement.

NOTATIONS:

Noted among patients receiving the GH were increases in mental stability, muscle accretion, weight reduction, higher energy, elevated libido, skin rejuvenation, and re-acquired hair color and density. In all 200 patients. No adverse side effects were noted. Of the original 200 patients participating in the study, 194 participated successfully in the program completing the 6-month study.

CONCLUSION:

The study suggests that a daily dosage of at least 4000 ng/ml of GH in a polymer matrix delivery system is an effective method for promoting the rejuvenation of cellular tissues when used sublingually in an oral application. The study found that test group subjects showed significant improvements in their serum levels of IGF-1 and HDL as well as decrease in their serum levels of LDL and triglycerides. Furthermore, the test subjects showed no negative serum readings in liver or kidney enzymes and reported no negative side effects.

The Dietary Supplement Health And Education Act (DSHEA) Under the 1994 DSHEA guidelines, low dosage, orally taken GH can be purchased without a prescription. The Dietary Supplement Health and Education Act (DSHEA) was passed in 1994. It created a new food category for dietary supplements. Hormones, such as progesterone, testosterone, DHEA and oral GH, may be marketed and sold as dietary supplements. The hormones fall into the category of foods and not drugs when they are produced in a safe form such as tablet, cream or liquid. To remove a dietary supplement from the market, the FDA must prove that the product causes undue harm.

Because of the unscrupulous advertising practices from the manufacturers of inferior dietary products, the FDA & FTC have made it clear that we may use the correct printed information that indicates rGH spray is indeed Growth Hormone on our website but that no-one may use the word Growth Hormone on the bottle containing the product for sale to the public; because we must fly under the radar screen. We must use Growth Factor instead, which is perfectly acceptable. We must also place the following statement on our website:

These statements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, mitigate or prevent any disease. OverTheCounter Rejuvenis Max is produced according to the guidelines of the Homeopathic Pharmacopeia of the United States. Furthermore, with respect to our Rejuvenis Max and Somastatin products, in order to comply with current FTC requirements, we must state all anti-aging benefits mentioned are associated with the injectable form of somatotropin and not our OTC HPUS products.