VITALIFE is a GRAS classified substance. Some of the observed subjective benefits of Vitalife in humans are listed below (see pilot study below)
Three studies are discussed: first, a pilot study that was mainly focused on evaluation of Vitalife based on a number of subjective and objective criteria; second, a clinical study to measure the relationship between GH and IGF-1 levels; third, an exhaustive multi-centered, double blind, placebo controlled study to measure several factors including endogenous GH release, effect on IGF-1, as well as levels of cortisol, glucose and several other biochemical safety indices.
First Clinical Pilot Study
A pilot study conducted in 1998 analyzed data obtained from 30 patients in response to treatment with Vitalife in an outcome based research model. Groups were divided into two main sections: athletic and sedentary. A total of 22 subjective criteria were monitored including sense of well being, overall energy, mental clarity, emotional stability, memory improvement, mood improvement, skin thickness, skin elasticity, wrinkle disappearance, new hair growth, skin texture, healing from old injuries, healing of overall injuries, range of motion, incidence of illness, body contour change, facial contour change, sexual frequency, stamina, libido, quality of erection/arousal, and change in nocturnia. The objective criteria measured included muscle strength, overall energy, exercise endurance and quality of sleep. In addition, baseline and post treatment IGF-1 levels and baseline chemistry data were also obtained.
Chart I. Percent Change in objective criteria measured in the pilot study.
The objective criteria were found to improve in the range of 60-93% over the baseline values as shown in Chart I. Even more encouraging improvements were observed in most of the subjective criteria.
Interestingly, IGF-1 levels were found to drop by more than 20% in both athletic and sedentary groups following three weeks of Vitalife treatment. Females showed a more marked decrease at 27%, while males also showed a decrease of 15%. These remarkable results were highly encouraging, and formed the foundation for further clinical studies.
- Improved and youthful appearance
- Decrease in appearance of wrinkles and saggy skin with improved facial contour
- Increase in lean body muscle mass
- Decreased recovery time after exertion
- Improved stamina and endurance
- Increased desire for protein and water
- Faster healing, quicker recovery from acute injuries and surgical procedures
- Improved strength and performance
- Reduction in chronic pain from old injuries
- Reduced duration with improved quality of sleep
- Improved sexual desire, performance and ability
- Decrease in anxiety, stress and depression
- Decrease in occurrence of general illnesses
- Improved overall health with a significant increase in a general sense of well being
Three studies are discussed: first, a pilot study that was mainly focused on evaluation of Vitalife based on a number of subjective and objective criteria; second, a clinical study to measure the relationship between GH and IGF-1 levels; third, an exhaustive multi-centered, double blind, placebo controlled study to measure several factors including endogenous GH release, effect on IGF-1, as well as levels of cortisol, glucose and several other biochemical safety indices.
First Clinical Pilot Study
A pilot study conducted in 1998 analyzed data obtained from 30 patients in response to treatment with Vitalife in an outcome based research model. Groups were divided into two main sections: athletic and sedentary. A total of 22 subjective criteria were monitored including sense of well being, overall energy, mental clarity, emotional stability, memory improvement, mood improvement, skin thickness, skin elasticity, wrinkle disappearance, new hair growth, skin texture, healing from old injuries, healing of overall injuries, range of motion, incidence of illness, body contour change, facial contour change, sexual frequency, stamina, libido, quality of erection/arousal, and change in nocturnia. The objective criteria measured included muscle strength, overall energy, exercise endurance and quality of sleep. In addition, baseline and post treatment IGF-1 levels and baseline chemistry data were also obtained.
Chart I. Percent Change in objective criteria measured in the pilot study.
The objective criteria were found to improve in the range of 60-93% over the baseline values as shown in Chart I. Even more encouraging improvements were observed in most of the subjective criteria.
Interestingly, IGF-1 levels were found to drop by more than 20% in both athletic and sedentary groups following three weeks of Vitalife treatment. Females showed a more marked decrease at 27%, while males also showed a decrease of 15%. These remarkable results were highly encouraging, and formed the foundation for further clinical studies.
Summary of results from first clinical study:
- Based on evaluation of several subjective criteria, Vitalife has the ability to improve quality of life by increasing vitality and a sense of well being.
- Initial results were obtained that showed that, while Vitalife increased GH concentrations, it simultaneously lowered the concentration of IGF-1.
Second Clinical Study: Measurement of Mean Endogenous GH and IGF-1
A second small clinical study was conducted whose analysis was based on the data obtained from 53 patients. The purpose of this study was to measure changes in GH and IGF-1 levels following a 2-week regimen of Vitalife applied at the conventional dose. Endogenous GH was measured using a radioimmunoassay technique after 30, 60 and 90 min. intervals. As an acute response to treatment with Vitalife, the GH level was observed to rapidly increase to 631% within 90 min. post-treatment (Chart IIA). When the GH levels based on initial treatment are compared to that after two weeks (Chart IIB) it was found that there was an improvement in the amount of GH released over time (1.08 vs. 2.57 ng/ml at the 90 min. point of measurement). This demonstrates that the system does not just stay sensitive to Vitalife, but also shows a cumulative enhancement in sensitivity over time.
How much GH is enough from a therapeutic standpoint? Diagnostically, GH levels are expected to show an increase of 5 ng/ml; less would signify GH deficiency. However, these data are collected based on experiments that subject the body to insulin and dopamine challenges, requiring an abnormal rise in GH levels, and thus do not reflect the true physiological requirements of GH.
Chart II (A) Change in endogeneous GH level within 90 minutes of initial treatment with Vitalife; (B) Level of endogenous GH release following 2 weeks of Vitalife treatment. (C) Changes in serum IGF-1 levels in males/females over 3 weeks.
A consistent and sustained increase in physiological GH levels under 5 ng/ml is likely to be adequate for anti-aging measures. A measurement of the IGF-1 levels showed a well defined drop over time, a critical characteristic of Vitalife therapy. The percentage drop in IGF-1 levels over a 3-week period of treatment in males was 14.6%, while the corresponding change in females was much sharper at 26.2% (overall for both sexes, 20.9%) (Chart IIC). This confirms the findings in the first clinical study and adds value to Vitalife as a highly significant alternative to exogenous recombinant growth hormone treatment.
A second small clinical study was conducted whose analysis was based on the data obtained from 53 patients. The purpose of this study was to measure changes in GH and IGF-1 levels following a 2-week regimen of Vitalife applied at the conventional dose. Endogenous GH was measured using a radioimmunoassay technique after 30, 60 and 90 min. intervals. As an acute response to treatment with Vitalife, the GH level was observed to rapidly increase to 631% within 90 min. post-treatment (Chart IIA). When the GH levels based on initial treatment are compared to that after two weeks (Chart IIB) it was found that there was an improvement in the amount of GH released over time (1.08 vs. 2.57 ng/ml at the 90 min. point of measurement). This demonstrates that the system does not just stay sensitive to Vitalife, but also shows a cumulative enhancement in sensitivity over time.
How much GH is enough from a therapeutic standpoint? Diagnostically, GH levels are expected to show an increase of 5 ng/ml; less would signify GH deficiency. However, these data are collected based on experiments that subject the body to insulin and dopamine challenges, requiring an abnormal rise in GH levels, and thus do not reflect the true physiological requirements of GH.
Chart II (A) Change in endogeneous GH level within 90 minutes of initial treatment with Vitalife; (B) Level of endogenous GH release following 2 weeks of Vitalife treatment. (C) Changes in serum IGF-1 levels in males/females over 3 weeks.
A consistent and sustained increase in physiological GH levels under 5 ng/ml is likely to be adequate for anti-aging measures. A measurement of the IGF-1 levels showed a well defined drop over time, a critical characteristic of Vitalife therapy. The percentage drop in IGF-1 levels over a 3-week period of treatment in males was 14.6%, while the corresponding change in females was much sharper at 26.2% (overall for both sexes, 20.9%) (Chart IIC). This confirms the findings in the first clinical study and adds value to Vitalife as a highly significant alternative to exogenous recombinant growth hormone treatment.
Summary of results from second clinical study:
- Vitalife increases endogenous GH by over 600% within a 90-minute interval.
- Vitalife maintains sustained and optimal levels of secretion of GH over time within the physiological limits of the system, compared to that achieved by exogenous recombinant GH.
- Vitalife assists in lowering the IGF-1 levels in a consistent manner, making a huge contribution to the safety profile of this GH-based therapy.
Third Clinical Study: Multi-centered, Double Blind Placebo Controlled Clinical Study
As a result of the remarkable success of the first clinical study, a larger, more detailed clinical study was undertaken. Data obtained from 117 patients were used to establish the relationship between GH and IGF-1 concentrations. Additionally, the effect of Vitalife therapy on cortisol, glucose, and other biochemical parameters was also measured.
Description of the Study: Dosing regimen of Vitalife was the same as in the previous study. Given the transitory nature of serum GH, the requirements of this study were extremely stringent to insure accuracy. Patient selection was made on the simple criteria that they should not be pregnant, and should be older than 30 years. The primary end point was 8 weeks post-treatment with Vitalife, when the placebo group was scheduled to cross over into the treated group. The secondary end point was measured at 16 weeks following the initiation of the treatment or placebo. The placebo was completely indistinguishable in color, odor and consistency from the Vitalife with both utilizing the same carrier and bar coded for identification in the same packaging. Neither the patients nor the supervising physicians were aware of which patients received placebo or Vitalife.
Chart III. Levels of endogenous GH at various week intervals, 90 minutes following Vitalife-treatment; values are reported as a percentage of the pre-treatment baseline values.
The patients had blood drawn at specific time intervals, starting with baseline (pre-treatment) for which GH radioimmunoassay levels were measured. In addition to that, the levels of IGF-1 and cortisol, as well as lipid and basic chemistry panels were also measured. Vitalife/placebo was administered and blood draws were conducted at 30, 60 and 90 min. intervals. Following the baseline readings, blood specimens were analyzed at the end of the second, fifth and eighth week following the initiation of the study. While blood had to be drawn at all the intervals for the placebo patients to preserve the double blinded nature of the study, the specimens for the second and fifth weeks for the placebo were discarded without testing to reduce financial costs, and also because no significant changes were expected in the placebo group warranting those additional tests.
Levels of endogenous GH: The results in this study followed the pattern of the first and second clinical trials. Thus 90 minutes following initial administration, the Vitalife treated patients showed a 462% increase in endogenous GH levels, and at the end of two weeks, the same reading had almost doubled to 816%. By the fifth week, the increase had gone up to a massive 1754%. The eighth week showed a drop in GH levels, but at 609%, the levels were still much higher than the levels prior to the start of the treatment (Chart III). These readings were demonstrated to be statistically significant.
Why is the increase in endogenous GH not as pronounced in the eighth week interval as in the fifth?
Referring back to the physiology of GH release, an increase of 1754% in the fifth week is a very significant increase in GH levels. It would not be surprising if such a large increase in endogenous GH stimulates the bodys defense mechanism of inhibiting GH release through increased somatostatin involvement. Given that the GH level is still comfortably well above baseline in the eighth week, it can be envisaged that continued Vitalife therapy will create a steady state endogenous GH concentration at expectedly youthful physiological levels.
There is a second possibility: the GH factory, a.k.a. the pituitary gland, has limited reserves of GH. Any stimulus that results in rapidly causing the secretion of GH will eventually cause depletion of GH reserves in the pituitary. At the same time, one would expect that decreased levels of GH in the pituitary should promote increased speeds in its biosynthesis. Attaining a steady state between secretagogue stimulus, GH production and GH inhibition at physiologically favorable levels is the expected outcome of Vitalife therapy.
Why is there an increase in the endogenous GH levels in the placebo group?
An interesting analysis of the placebo group showed that the endogenous GH levels increased by 118% over the baseline reading on week 8. This was not altogether unexpected, since it validates the understanding that other factors can and do affect the levels of endogenous GH. Specifically, all the patients were instructed to include a specific combination of aerobic and resistance exercises as well as a high protein, low carbohydrate diet. All these factors promote the stimulatory effect of GHRH effecting higher GH release (see Fig 1).
Chart IV (A) Changes in levels of IGF-1 and glucose 90 min. after Vitalife treatment; (B) Consistent drop in serum IGF-1 concentration in the 8-week study.
Changes in serum IGF-1 levels: As expected from the previous study, IGF-1 levels were shown to drop dramatically within the first 90 minutes of first application of Vitalife (Chart IVA), followed by a steady decline at the 2, 5, and 8-week checkpoints (Chart IVB). It is interesting to note that a drop in serum IGF-1 levels of 26% was observed despite a corresponding 1754% increase in endogenous GH levels at the same time point of 5 weeks. This clearly shows that endogenous GH levels are not related to the levels of IGF-1 as expected from the hepatic biotransformation pathway.
Changes in serum glucose levels: Vitalife appears to have a euglycemic effect on serum glucose levels. The average trend is shown in Chart IVA wherein the glucose levels appear to drop from higher levels. In reality, patients with glucose levels below 75 mg/dl showed an upward trend towards 100 mg/dl, while those with glucose levels above 150 mg/dl trended downwards to 110 mg/dl. Patients with insulin dependent diabetes mellitus showed serum glucose drops between 50 and 70 mg/dl within 90 minutes of treatment. This equilibration tendency may have direct bearings to the stabilization of IGF-1 and insulin production pathways.
Chart V. Changes in cortisol levels in a 90 min. acute measurement at different time intervals, as well as percentage drops over the different time points.
Changes in serum cortisol levels: Cortisol levels were of great interest for a couple of reasons. Cortisol, also known as the stress hormone correlates with subjective problems related to attitude, depression, anxiety, sense of well being, ability to focus and concentrate, as well as ability to handle stress. Patients were asked to fill out self-assessment forms that covered these subject areas. Interestingly, several patients reported improvements in all these areas 3-4 months downstream into the treatment.
From a quantitative standpoint, serum cortisol levels were shown to decrease rapidly within 90 minutes of administration of Vitalife (Chart V). From the long term perspective of the treatment, cortisol levels were shown to steadily decrease following the second week of administration (Chart V)
Additionally, cortisol is correlated with inflammatory response, which in turn contributes to the increased rate of aging. Reduction in any inflammatory component may have an impact in reducing oxidative stress on the physiology and improving the natural peak and trough nature of cortisol, as opposed to maintaining chronically elevated levels.
Effect on other serum parameters: Charts VI and VII (next page) show the data obtained by the measurement of serum chemistry parameters, reported as a percentage increase or decrease from the baseline value at the end of the eighth week of the study. Notable among this data is the strong increase witnessed for gamma glutamyl transpeptidase (12.47%) while bilirubin and creatinine dropped significantly by 34.56% and 22.23% from the baseline prior to treatment.
Chart VI. (A) Changes in chemistry parameters measured as a percentage change from the baseline value prior to treatment to the values retrieved at week 8. GGT = gamma glutamyl transpeptidase.
Chart VII. Changes in chemistry parameters measured as a percentage change from the baseline value prior to treatment to the values retrieved at week 8. GOT = glutamate oxaloacetate transaminase; GPT = glutamic-pyruvate transaminase; BUN = blood urea nitrogen; HDL = high density lipoprotein; LDL = low density lipoprotein.
Summary of results from third clinical study:
- The progressive increase of endogenous serum GH, with concomitant decrease of serum IGF-1 was further confirmed, adding credibility to Vitalife as an anti-aging therapy with an excellent safety profile.
- Decreased levels of cortisol and equilibration of blood glucose levels were significant indicators that have implications in the control of anxiety and stress related disorders and blood sugar control, respectively.
- Significant drops in levels of bilirubin and creatinine were observed over the 8 week treatment range.
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