Safety & Testing

Human Studies on StayActiv - Capsules / Cream

Capsules

To determine effectiveness of StayActiv supporting natural pain relief and recovery in vivo, a study was designed in which 32 human volunteers were asked to use StayActiv for a time span of at least thirty days. During the duration of the study the subjects were asked to administer StayActiv if they experienced any kind of musculoskeletal discomfort.

The dosage of StayActiv they were to administer was two 500 mg capsules daily (as needed). The subjects were also asked to use StayActiv in place of regular non-prescription anti-inflammatory pain relievers. The following data was obtained from 5 years of studies and trials performed on StayActiv and have been validated as displaying the effectiveness of StayActiv along with a subjective measure of how it compares to other non-prescription musculoskeletal pain relievers.

As a follow-up, the participants were asked to provide feedback on various parameters as outlined in a survey. The questions included:

1. The specific kind of routine (non-disease related) pain the subject experienced and how effective StayActiv was in supporting relief of the pain on a ten-point scale.

2. How often the subject took StayActiv

3. The amount of elapsed time between the taking of StayActiv and noticed relief.

4. The kind of relief that was experienced from the supplement.

5. Have they used over-the-counter pain relievers and if so how many different types and their names.

6. Compare the effectiveness between non-prescription anti-inflammatory compounds and StayActiv.

7. The overall experience and effectiveness of the product.  

The subjects reported on the level of pain relief they experienced on a scale from 1 to 10, 1 being ineffective and 10 being very effective. The subjects were to report this range of effectiveness scale for each pain. The suggested categories in the survey included:

The results of the responses are shown in the following figure for each pain type and the effectiveness of StayActiv on promoting natural relief of the associated symptoms. The overall results showed that StayActiv proved to be effective in a variety of indications and in most cases, subjects reported the product as being highly effective with scoring in the 9-10 range.

The subjects were also asked to report on the amount of recommended doses of the encapsulated StayActiv they ingested per day or per week. The percentage of the subject’s StayActiv intake amount was as follows:

1. Once time per week - 3.33%

2. 2 or 3 times per week - 33.33%

3. Once per day – 60.00%

4. 2 or 3 times per day – 3.33%

The subjects also were asked to describe what non-prescription pain relievers they had used in the past. Not surprisingly, 76% reported that they had used non-prescribed remedies for musculoskeletal pain. The various pain relief products they had tried included: Aspirin®, Aleve®, Tylenol®, and Ibuprofen (more specifically Motrin® and Advil®).

These subjects were asked to compare the effectiveness between those products and StayActiv. Interestingly, over 90% reported that StayActiv was more effective, and the remaining 10% reported StayActiv was equally effective as the market’s top products. The most impressive information obtained in this survey was the fact that no subject said it was less effective than any over the counter product they had previously taken.

The survey included subjects being asked to report on what they experienced after taking StayActiv. Since the study subjects took StayActiv for a variety of different everyday aches and pains the following list summarizes their responses related to their experiences of the effectiveness of StayActiv for promoting relief of their condition.

Of the 32 test subjects:

• 68.75% reported relief in muscle fatigue and/or strain
• 75.00% reported prevention of muscle fatigue and/or strain
• 87.50% reported improvement in overall muscle strength or muscle energy level
• 31.25% reported improved effectiveness when dosage and/or frequency increased
• 68.75% reported increased energy level and work rate ability
• 84.38% reported increased muscle comfort while exercising
• 6.25% reported improved mental acuity and memory/cognitive functions
• 0.00% reported “no positive effect” from the use of the product

Safety and Toxicity Studies

Because people are concerned with side effects of any supplement or product they use, safety concerns relating to StayActiv were divided into separate categories: (1) in vitro toxicity data, and (2) in vivo animal toxicity data.

In Vitro Toxicity Data Concerning StayActiv

As skeletal muscle is a major target tissue for amino acid supplements, and has the highest stores of amino acids in the body, the toxicity of StayActiv was examined in vitro using a mouse skeletal muscle cell line (C2C12). For these studies, cultured C2C12 cells were exposed to various concentrations of StayActiv (0-100 mM) for a period of 4 hours.

After 4 hours of exposure, the cells were washed and provided fresh culture media and incubated, under aseptic conditions, for an additional 72 hours. Toxicity was assessed using the MTT assay17. The data from these studies are provided in Appendix 1. Within the concentration range examined, there were no statistically significant effects of StayActiv on C2C12 cell viability.

The effects of StayActiv on cell viability were similar to that observed with SAC, a commonly used form of amino acid supplementation.

In vivo Toxicity Data Concerning StayActiv

In vivo studies were also performed in adult male Sprague-Dawley rats to evaluate the toxicity of StayActiv. Rats were dosed for seven consecutive days with StayActiv via oral gavage. The dosage administered was calculated based on a 30 g equivalent in a 70 kg human (i.e. 430 mg/kg). This dose was chosen as it represents the highest daily dose of StayActiv to be taken by humans (as reported in Section 4.0 Level of New Dietary Ingredient).

A total of eight rats were randomly selected for the treatment group (StayActiv). The control group consisted of an additional eight rats that were given physiological saline solution (2 ml/kg) via oral gavage for seven consecutive days. The parameters assessed included weight gain as well as a complete metabolic panel for blood chemistry at the conclusion of the study. In addition, 2 rats from the treatment and control groups were chosen at random for comprehensive necropsy. The data from these studies are maintained on file.

These studies show no significant changes in weight gain between the control and treatment groups over the seven-day course of the study. Furthermore, no significant differences in blood chemistries were observed between the StayActiv treated and vehicle control groups at the conclusion of the study. The various blood tests performed included protein, albumin, glucose, calcium, potassium, sodium, and chloride levels; liver enzymes (ALT, and AST levels); and renal function (BUN, amino acids and BUN/amino acid ratio).

Comprehensive necropsy of selected StayActiv treated and control rats showed no gross lesions. Histopathological examination of selected tissues, including liver, kidney, bladder, stomach, heart, brain, and spleen showed no abnormalities (necropsy reports from Research Animal Diagnostic Laboratory, University of Missouri, are included in the material below). Based on the animal studies shown, there is no evidence of toxicity with the oral consumption of StayActiv at a dose equivalent of 30g in humans.

In vivo toxicology study for StayActiv salts in adult, male Sprague-Dawley rats. Rats were treated with 430 mg/kg of StayActiv or the vehicle control (physiological saline solution; 2 ml/kg) for a period of seven consecutive days. The rats were dosed once a day via oral gavage. The dose selected represented a 30 g daily dose equivalent in humans. A total of 6 rats were selected for the StayActiv treatment and vehicle control groups.

Weight changes were recorded for all rats during the course of the experiment. Blood samples were collected from all rats at the conclusion of the study for a complete metabolic panel of clinical tests. Finally, two rats from each group were randomly selected for comprehensive necropsy by an independent contract veterinary research facility.

Necropsy report from RADIL, University of Missouri

NECROPSY:

No gross lesions were detected in any of the body systems and organs examined.

Human In Vivo Data Concerning StayActiv

Early human experience with StayActiv involved volunteer adult males ranging in age from 39 years to 64 years. The daily dosage and length of exposure to the supplement ranged from 1.0 to 3.0 grams and 238 to 414 days respectively. No significant abnormalities in blood or urine chemistries were noted.

All blood and urine chemistries were performed at the clinical laboratory of the Nebraska Health Systems, Omaha, Nebraska. The complete laboratory findings are maintained on file.

Summary

Dietary supplements containing amino acids have been available to consumers for over two decades. Over this time, no significant health concerns have been identified in either controlled human studies, or acute and subacute toxicity studies in laboratory animals. StayActiv is a new analog of amino acids with improved properties.

Based on both our in vitro cell culture studies examining acute StayActiv toxicity and in vivo rat studies examining exposure to StayActiv, there were no apparent indicators of toxicity with this compound.

In addition, blood and urine profiles human males on daily supplementation with StayActiv that ranged from 1 to 3 grams taken from 238 to 414 days at the time of testing showed no significant changes in their blood or urine chemistries. Thus, this data, along with the historical experience with amino acid based products, indicates that this new amino acid derivative is safe when used in accordance with the packaging instructions.

Various doctors specializing in the fields of pharmacology, endocrinology, pathology, and sports medicine also reviewed StayActiv, and all concluded and agreed that StayActiv is biologically safe. In clinical trials, there have been no negative side effects reported at recommended doses. Research showed that StayActiv clearly exhibited superior chemical characteristics regarding bioavailability and also optimized support of healthy muscles and joints.

The data herein shows StayActiv effectively supports relief and recovery from both sources of musculoskeletal pain, that being prostaglandin release and lactic acid production (no other product on the market is able to accomplish this). StayActiv was also demonstrated to be equally or more effective at promoting relief of routine (non-disease) musculoskeletal pain and soreness as compared to leading OTC products on the market today. StayActiv works both safely and naturally, without any side effects. Through rigorous studies StayActiv clearly showed that it was collectively the safest and most effective product in supporting and promoting natural relief and recovery of routine pain found in the musculoskeletal system.

Human Studies on StayActiv - Capsules / Cream

Cream

The active ingredient in StayActiv topical is a compound that is known, in high doses, to cause swelling, cramping, pain, discomfort, and other maladies in the human body and extensively reported in the literature. However, small doses of this compound have the opposite effect and support the body’s recovery from swelling and discomfort as described above.

A study designed to evaluate the effectiveness of topical StayActiv on relieving the symptoms associated with inflammation and pain involved 37 volunteers who used the StayActiv product for a time span of at least thirty days. The study group ranged in age from 18 to 87 years and was comprised a 60/40 male/female ratio.

During the duration of the study the subjects were asked to administer the topical StayActiv cream if they experienced any kind of musculoskeletal discomfort or any itching or skin irritation. The subjects were to apply the cream directly at the location of the discomfort. The dosage and times of administration of topical StayActiv was “as needed.” Since the dosage instructions were as needed, the reported usage varied from several times daily to once per week. The subjects were also asked to use StayActiv in place of their regular over the counter anti-inflammatory topical pain relievers. They were then asked to provide feedback on various parameters including:

• The specific kind of pain the subject experienced and how effective StayActiv cream was in alleviating the pain on a ten-point scale.
• Have they used other over the counter topical pain relievers and if so how many different types and brands. • Compare the effectiveness between other topical creams and StayActiv in providing relief.
• The elapsed time between the applying of StayActiv and noticed relief.
• The kind of relief that was experienced from the application of StayActiv.
• The overall experience and effectiveness of the product.

The subjects scored the level of pain relief they experienced on a scale from 1 to 10 with a score of 1 being ineffective and a score of 10 considered to be very effective. Since musculoskeletal pain and inflammation can occur from a variety of different causes and perhaps a combination of different aliments, each subject was asked to rate the effectiveness of topical StayActiv for each indication they were encountering.

The suggested categories or indications in the survey included:

The average score for relief in each indication or category of affliction that initiated the subject to use topical StayActiv is illustrated in the following graph.

The results showed that when StayActiv was used as a pain reliever it was scored to be effective for all indications reported and was highly effective in the majority with ratings greater than 9.0.

The subjects were next asked to identify any other over the counter pain relievers that they had used and how they compared in effectiveness to StayActiv topical cream. Approximately 50% had used topical pain relievers prior to this study; some reported using up to four different products because of the lack of any satisfactory effectiveness. The other products listed included Capsasin, Hydrocordisone, Icy Hot, BenGay, Topical Aspirin Cream, Ibuprofen Topical Cream, Sports Cream, Biofreeze, and Blue Ice.

When comparing the effectiveness of these other topical pain relief to StayActiv, 90 % (33/37) reported that StayActiv topical was considerably more effective. The remaining 10% stated that StayActiv was at least equally effective as the market’s top selling products. The most impressive information obtained was the fact that no subject said StayActiv topical was less effective than any product they had previously used, regardless of the indication they targeted for relief.

The participants were asked to indicate the time range of when they first experienced relief from the pain after applying topical StayActiv. The data is shown in the following table:

As shown, over 70% of the subjects reported relief within 15 minutes following application with over 85% reporting relief within 30 minutes. None of the 37 subjects reported that StayActiv was ineffective or achieved "no relief "of pain, regardless of the indication treated.

The survey concluded with subjects asked to report on was what they experienced after using topical StayActiv. Since the study subjects used StayActiv for a variety of different aches and pains, the following list summarizes their responses related to their experiences of the effectiveness of StayActiv (SA) for providing relief of their condition.

Of the 37 test subjects:  

• 91.9% reported AA relieves muscle and joint pain
• 51.4% reported prevents muscle and joint pain from returning
• 64.9% reported improves joint mobility
• 64.9% reported improves muscle flexibility
• 62.2% reported relieves fatigue or strain
• 21.6% reported prevents fatigue or strain
• 18.9% reported improves muscle strength and/or energy
• 0.00% reported “no positive effect” from the use of the product

The were provided the opportunity to provide any additional (freely scripted) comments describing their overall experience when using the topical StayActiv cream. Below are their comments verbatim:

• Immediate relief
• Made fibromyalgia pain better and more bearable
• Prevents arm from aching - helps recover faster
• Works well - used less frequently after initial application
• Fast recovery - not sore next day - used as preventative
• Relieved pain from car accident in shoulder and neck – had for years • Stopped swelling - worked on shin splints
• Good anti-inflammatory effect - absorbs easily into skin
• Doesn’t smell or stain
• Good product
• Works great - no smell - not sticky - doesn’t stain clothes
• Fast relief of pain
• After a few applications used less and less, pain gone after a week
• Product worked well
• Overall worked well - increased flexibility - back and shoulder pain gone from old injury
• No smell - absorbs well - leaves skin smooth and supple
• Took away muscle pain created around adjusted neck vertebrae
• Most effective as prevention of muscle fatigue the next day after working out
• Made pain go away for extended periods of time or permanently
• Pretty amazing how quickly and effectively it relieves muscle soreness
• Impressive results
• Had shoulder surgery and physical therapy for over a year with constant ache, used topical and it worked
• Works well
• Wake-up at night with hip pain, used cream and pain stopped in minutes and went back to sleep