Wound Healing Activity

In a 1997 study, immediately following surgery, (animal) subjects were randomized to receive either an amino acid diet or a peptide diet for 10 days and the strength of the wound was measured. Wound bursting pressure was found to be significantly higher in subjects receiving the peptide diets than in those just receiving amino acid diets. The authors suggest that dietary peptides may stimulate the production of growth factors such as growth hormone, insulin, or insulin growth factor (IGF-1). They also postulate that it is possible that the amino acid entry into the cell via peptide transporters is more efficient for stimulation of protein synthesis than entry in the form of just amino acids. Other possible mechanisms suggested by the authors for the increased wound healing with peptide versus non peptide diets include stimulation of collagen synthesis, increased blood flow to the wound, free radical scavenging, and generation of cytokine profiles which better support wound healing.

Cortisol Study

This study was designed to ascertain the effect of the nutritional supplement, Laminine on cortisol levels in the body. During the experiment, 28 subjects, 16 women and 12 men, between the ages of 36 and 83 took part in the study. Salivary cortisol level content of each participant was measured prior to him/her taking part in the study. This figure is known as "pre-Laminine usage level." The salivary cortisol level was also measured every fifth day three times throughout the study when each participant's intake amount was changed. Overall, study participants' cortisol levels were reduced by an average of 23.7 percent, where 16 started on a higher intake of Laminine—four capsules, twice a day—and 12 started on one capsule twice per day. Participants that initially started on a higher intake of Laminine saw their cortisol level reduced significantly over the first four days as compared to subjects that began the study with a lower usage amount. However, at the end of the study, there was a small, although insignificant, difference in favor of the high initial intake. The total cortisol reduction by the end of the study was 27.3 percent in women and 19.2 percent in men.

While the results of this study are encouraging, additional tests with a larger sample size are needed to validate the findings.

The Effects of Laminine on Normal Blood Sugar Levels

Cholesterol Profiles Study

The study was designed to test the effects of the nutritional supplement, Laminine, independently and in combination with Laminine OMEGA+++, on cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides and blood pressure. There were 15 individuals in the study, broken into three groups of five. This was a double-blind placebo-controlled study that took place over a total period of 12 weeks.

The study took place during two phases. The first lasted eight weeks and included Groups A, B, and C. Cholesterol serum profiles and blood pressure were taken from participants in each group at the start of week one and at the conclusion of week eight. During this phase of the study, participants took a total of four supplements a day—two in the morning and two in the evening. The second phase of the study only included participants from Group A and lasted an additional four weeks, after which time cholesterol serum profiles were measured again. During phase II, participants in Group A consumed eight supplements a day—four in the morning and four in the evening.

During the first phase of the study, results showed that the average cholesterol down-regulation in Group B was about 9.8 percent, compared to 11.5 percent in Group C. Meanwhile, cholesterol levels in Group A actually rose by 1.0 percent over the first eight weeks but normalized by 11 percent between weeks nine and 12. Results for LDL and triglycerides generally followed a similar pattern.

Subjects in Group A were also given a subjective survey at the conclusion of Phase II, when they were asked to rate improvement in their joints, memory, skin, sexual drive, muscle tone and strength, stress levels, sleep and emotional wellbeing. Of the five subjects in Group A, only four chose to be a part of the survey. After Phase II, the average improvement in all categories was about 5.75 on a scale of 0-10, with zero representing no change and 10 representing a significant improvement. These are subjective results but nonetheless notable.

Cholesterol Profiles Study Discussion

Triglyceride levels in Group A normalized by 267 mg/dl or 58.2 percent during Phase II, the most substantial change throughout the duration of the study. However, participants in Group C experienced the best and most consistent overall results. HDL levels were within normal limits both at the beginning and end of the study for all participants.

Although participants in Group A took double the Laminine and Laminine OMEGA+++ during Phase II, results were not drastic enough to recommend doubling the suggested usage for Laminine OMEGA+++ for all individuals. The down-regulation in LDL was not significant in Group A during Phase II as compared to Group C during Phase I. Nevertheless, for individuals that do have high triglyceride concerns, doubling the intake of Laminine and Laminine OMEGA+++ can yield a normalization in a short period of time.

These data suggest that Laminine OMEGA+++ helps to down-regulate cholesterol, LDL, triglyceride and blood pressure levels (Group B), but when taken with Laminine, the benefits are more significant as a whole (Group C after Phase I and Group A after Phase II).

A study of this size has an estimated margin of error of approximately 30 percent. Therefore, while the results of this study are encouraging, additional tests with a larger sample size are needed to validate the findings.

THE EFFECTS OF IMMUNE+++ AND LAMININE ON NORMAL WHITE BLOOD CELL COUNT LEVELS

Laminine® and DIGESTIVE+++ Supplementation Improves Gut Health as Determined by Pilot Clinical Trial Showing Increased Short Chain Fatty Acids Production in the Colon, Especially Butyrate

A pilot clinical study was conducted to observe the efficacy of subjects consuming two dietary supplements, Laminine and DIGESTIVE+++ over a four-week period.

DIGESTIVE+++ dietary supplement contains a prebiotic blend of fructooligosaccharides, Jerusalem Artichoke (90% inulin), Dandelion leaves, and Yacon root. Additionally, the DIGESTIVE+++ supplement contains the spore forming probiotic Bacillus coagulans. The product also contains a digestive enzyme blend to digest proteins (at various pH's), carbohydrates, lactose, and fats. The enzyme blend consists of Amylase, three different Proteases, Alpha-galactosidase, Glucoamylase, Lactase, Invertase, Lipase, Acid Maltase, Peptidase and Flaxseed oil.

Subjects consumed 2 capsules of Laminine daily (one in the morning and one in the evening) and one capsule of DIGESTIVE+++ taken twice a day, (i.e. one capsule with each of the two heaviest daily meals). Ideally the DIGESTIVE+++ supplement should be taken 30 minutes before the meal but at least taken within the same hour of eating the meal, for a period of 4 weeks.

Subjects were asked to refrain from using other supplements prior to the study and to provide the doctors with initial baseline stool samples and again after 4 weeks supplementation. Data of the subjects upon completion of the trial from the Comprehensive Digestive Stool Analysis (Genova Diagnostics, Asheville, North Carolina) showed a substantial increase (28%) in both total Short Chain Fatty Acids (SCFAs) and 28% increase in butyrate production. Dietary carbohydrates, resistant starches and some fibers are substrates for fermentation that produce SCFA specifically acetate, propionate and butyrate, as end products. The rate and amount of SCFA production depends on the species and amounts of microflora present in the colon, the substrate source and gut transit time. SCFAs are readily absorbed. Propionate is largely taken up by the liver. Acetate enters the peripheral circulation to be metabolized by peripheral tissues. Butyrate is the major energy source of colonocytes.

Subjects taking Two Laminine Dietary Supplements Twice Daily and Applying Lamiderm Apex Skin Serum Twice Daily to the Face Showed Highly Significant Increases in Collagen and Elastin Units as Measured by 3-Dimensional Magnified Skin Analyses Photographs

A group of nine subjects (4 females and 5 males) were evaluated at baseline and after 6 months applying Lamiderm Apex High Performance Skin Serum to their faces twice daily. Subjects also consumed 2 Laminine capsules twice daily for 6 months. Subjects were evaluated every month using the 3-D Skin Analyzer (GA-2000) which provides 3-dimensional real-time images. High resolution photographs (2560 × 1920) using a 5.0 Mega pixels sensor are stored in a specialized computer program. Photographs at baseline can be compared to photographs taken after the treatment phase for observing differences in the parameters of skin integrity. The images convert into unit readouts for Collagen, Elasticity, Sebum, Pores, Acne, Pigment, Sensitivity and Moisture. Investigators evaluated changes in Collagen and Elasticity units over 6 months.

The results evaluated differences in the collagen units from baseline and after 6 months use of products. Statistical evaluations (related sample t tests) for all groups showed highly or very highly significant increase in collagen units for the group of 9 subjects and for the female group and the male group. The same was true for the elastin values measured by related samples tested, as all groups showed highly significant or very highly significant increases in elastin units. The results of the study indicated that applying Lamiderm Apex topically and leaving one application on the face overnight while consuming the dietary supplement Laminine, showed highly significant skin improvement in all subjects.

3D Analyzer Magnified Photographs with Contrast Images (left-hand corner) Showing Changes in Skin Elastin for a Male Subject

3D Analyzer Magnified Photographs with Contrast Images (left-hand corner) Showing Changes in Skin Collagen for a Female Subject

Overview of Safety and Efficacy Study of Lamiderm Apex Serum Application Twice Daily in 20 Female Subjects ages 35 to 65

A study conducted by Dermatest GmbH Laboratory for Allergologic and Dermatologic Research (Munster, Germany, 2017) evaluated the safety and efficacy of Lamiderm Apex High Performance Skin Serum. Twenty subjects applied Lamiderm Apex to a clean face in the morning and again at night before bed. State-of-the-art dermatologic testing instruments validated effectivity of Lamiderm Apex increasing wrinkle reduction, fading dark spots and increasing elasticity all at highly significant differences before and after Lamiderm Apex application.

Wrinkle depth was measured with the PRIMOS optical 3D portable in-vivo measurement device, which measures the skinfold depth of a single wrinkle. The wrinkle reduction differences in the 20 subjects were measured by a paired t test and found to be statistically significant (Wilcoxon matched pairs test, p<0.001) with the averaged wrinkle decrease of 31.77%. Because wrinkle reduction may involve collagen fibers production, the 3D Skin Analyzer values may correlate to enhanced collagen units from the 3D scanner.

The Dermatest clinical trial measured skin elasticity using a standard cutometer (Cutometer MPA 580 Fa. Courage+Khazaka electronic GmbH). The changes observed were found to be statistically significant (Matched samples t test, p<0.001) for the 20 subjects and resulted in an averaged increase in elasticity of 14.62% after 4 weeks application of the Lamiderm Apex serum. The cutometer elasticity values could be correlated to the elastin units of the 3D Skin Analyzer.

The Dermatest clinical trial examined the lightening of age spots before and after the 4-week application period using spectrophotometry. Age spots (Lentigines seniles, Lentigines solares) are blemishes on the skin associated with aging and exposure to ultraviolet radiation from the sun. The skin color pigment melanin is responsible for the occurrence of age spots. These spots range in color from light brown to red or black and are located on areas most often exposed to the sun, particularly on hands, arms, shoulders and the face. Nearly 90% of all people older than 60 years have age spots on their skin. The used spectrophotometer CM 700d (Konika Minolta Sensing) allows high-resolution measurements using standard illuminate type C (Commission Internationale de l'Eclairage: International Commission for Illumination). A sensor cell measures the spectral reflection for different wave lengths or a narrow range of wavelengths of the evaluated dark spot. The reflection data is calculated to provide standard color values enabling the numerical depiction of the results. In the twenty subjects evaluated for a 4-week application of Lamiderm Apex Skin Serum, the results showed an average lightening of 7.40% which was statistically significant (Matched pairs t test, p<0.001).

Laminine contains a 9-day fertilized chicken egg extract and quality proteins (shark cartilage and pea). Recent investigations showed the LifePharm proprietary Egg Extract contained several growth factors, as well as, fibroblast growth factor 2. These are transforming growth factor B-1 (TGFB-1) and platelet derived growth factor (PDGF). These were identified to stimulate collagen, elastin and fibronectin (wound repair fiber) production in human dermal fibroblast cultures (Lloyd K, Suyanto W, Hinek A, 2016). Fibroblasts are the most abundant cells in skin and connective tissues with the primary function to secrete collagen and elastin for tissue strength, texture and functionality. Fibronectin fibers increased by 350% in human dermal fibroblasts when treated with LifePharm Proprietary Egg Extract. Fibronectin is the extracellular matrix fiber that is responsible for wound repair and scar reduction.

Lamiderm Apex High Performance Serum also contains a proprietary blend of extracts from the fruits of blueberry, pomegranate, strawberry, kiwi, and cranberry known for antioxidant protection and reversal of UV damage. A proprietary extract of Alpine herbs and plants has shown effectivity in inhibiting melanin production and to lighten age spots. Vitamin C is also an effective skin lightening agent. An extensive research report evaluated all ingredients at their effective concentrations in the product and met European standards of highest quality and safety.

Lamiderm Apex High Performance Serum was given the 5 Star Excellent Rating by Dermatest GmbH as it was Dermatologist tested for clinical safety and nonallergenic. There was no irritation caused by long term application of the serum. Because it was shown effective at highly significant levels for wrinkle reduction, dark spot reduction and increasing elasticity it was given the Excellent rating as well for effectively improving skin. Laminine supplementation may stimulate skin elasticity and collagen production by delivering growth factors and nutrients from the blood supply to the skin. Laminine provides high-quality proteins, amino acids, peptides, vitamins, phospholipids and nutrients important for nourishing cells of all types. Protein supplements have been shown to influence the texture, elasticity and thickness of human skin in clinical trials. The synergistic combination of consuming the oral supplement and applying the Lamiderm Apex Skin Serum shows strong indication of supporting wrinkle reduction, increased elasticity (firmness) and for fading dark spots.

Disclosures

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Laminine Helped Maintain Normal Cell Growth

We studied the effects of Laminine on skin cells in order to assess growth and repair (Figure 1). We used various concentrations of Laminine on skin fibroblast cultures to assure the product is safe and does not impede cell proliferation which is indicative of growth and healing. For this experiment, we grow skin fibroblasts in multiple well dishes with growth medium containing varying concentrations of Laminine. We incubated the cells for 1 week and analyzed cell growth using a neutral red assay, a well-developed and widely used cytotoxicity test that can quantitatively estimate the number of viable cells (11). The data suggest that Laminine is not toxic to cells and can help maintain normal cell growth in vitro (Figure 1).

Figure 1: Effects of Laminine on skin fibroblast cells vs standard growth method (control). Laminine 1, Laminine 2: Different lots of Laminine. Arrow denotes the projected physiological concentration of Laminine when a person of average weight (150 lb) takes one Laminine capsule.

Telomerase Activity in Subjects Consuming Four Laminine Daily for Ninety Days

Since telomerase activity may play a critical role in maintaining health and longevity, we next performed a telomerase activity assay on samples of blood from patients that had consumed Laminine. Eight subjects consumed 4 Laminine daily for 90 days. We took blood samples from individuals at day 7 and day 1 prior to Laminine consumption (Pre), and 30, and 90 days post Laminine consumption in order to assess if Laminine changes levels of telomerase activity (Fig 2). The data suggest an increase in telomerase activity for 50% of the patients and no decrease in telomerase activity during the 3 -month study. An average of the 8 patients suggested an overall increase of telomerase activity.

Figure 2. A) Relative telomerase activity of individual samples: Crude lysate from 4.5×103 cells of each sample was assayed for telomerase activity. The relative telomerase activity (RTA) was obtained by correction over heat-inactivated lysate; by normalization to an independent internal control of each reaction; and by comparison to the RTA of crude lysate from 4.5×103 HeLa cells. The RTA fold-changes of 30 day and 90 day post-treatment over the average of the two pre-treatment RTA were plotted.

REFIVE Clinical Study

All five of the Lifepharm products have been combined into a sealed packet for convenience, freshness, and conservation. The packets contains two Laminine capsules, an OMEGA+++ softgel, an IMMUNE+++ tablet and a DIGESTIVE+++ capsule. There are thirty packets per box.

A clinical study was undertaken at a Health and Wellness Clinic in Diamond Bar, California by a physician to evaluate safety and efficacy of subjects consuming a REFIVE packet for ninety days. Twelve subjects (32-68 yrs.) consumed a REFIVE Packet daily for 90 Days. Subjects signed informed voluntary consent agreements and were given information about each supplement contained in the REFIVE packet. Subjects refrained from taking other dietary supplements and were requested to maintain their normal diet and lifestyle. Subjects were asked to fast the night and morning before blood samples were taken. Blood was drawn at baseline (before taking supplements) then at 30, 60 and 90 days during the treatment. The parameters assessed included a standard comprehensive metabolic panel conducted by Quest Diagnostics. The parameters measured included cholesterol, LDL (low density lipoprotein), non-HDL (non-high-density lipoprotein), dehydroepiandrosterone (DHEA), triglycerides, blood glucose, cortisol, creatinine, and blood urea nitrogen (BUN), including the complete blood count. These were parameters thought to be of value.

Results: Cholesterol, triglycerides, glucose and cortisol were the parameters that showed substantial improvement in the group and thought good indicators on effectivity of the combined supplements. Values of other blood lipoproteins or ratios sometimes showed baseline and treatment values out of normal range and were not included. Creatinine and blood urea nitrogen remained within normal ranges throughout the clinical treatment period indicating safety. DHEA levels remained fairly constant in subjects during the supplementation period. This was a valuable indicator that the products did not affect this steroid hormone. DHEA, as the most abundant steroid hormone, is the intermediate in the synthesis of androgen and estrogen steroids.

Conclusion: It was remarkable that several of the primary health parameters showed fairly consistent positive change in the evaluated groups of participants. A brief questionnaire included comments that bowel regularity was achieved. Overall comments included subjects expressing a sense of well-being with good daytime energy and concentration. Sleeping was mentioned as improved for many of the participants. A night-shift worker and four other participants responded that they seemed stronger and better able to manage stress of work, along with stress of family issues (adult children issues, recently deceased parent, caretaking of elderly or sick parent). All subjects were eager to participate and were compliant in taking the supplements regularly. The subjects' responses were positive and there were no comments or reported unwanted side effects.

85% of Subjects Evaluated Showed Improved Glucose Level Maintenance.

Maintaining healthy blood sugar helps keep blood vessels from becoming damaged as high blood sugar and its side reactions of glycated end products, destroys vascular tissues and increases risks of heart disease and stroke. Controlling high blood sugar improves circulation to such vital organs as the heart, brain, kidneys, eyes, legs, feet and nervous system.

Laminine has been investigated in 2 peer reviewed studies showing that it helped maintain healthy glucose levels as measured by HA1-C when 2-4 Laminine capsules were taken daily for a period of three months. Laminine may be considered as an adjunct supplement for supporting the maintenance of healthy glucose levels while the physician monitors closely blood glucose levels for the individual and they take prescribed medication properly.

71% of Subjects Evaluated Showed Improved Cholesterol Level Maintenance.

Maintaining healthy cholesterol levels helps reduce arterial plaque formation and lowers the risk for heart disease and stroke. OMEGA+++ not only contains a pure and recommended ratio of EPA and DHA source of the Omega 3- fatty acids but CoQ-10 and Vitamin K2. Co-Q-10 helps the metabolic and energy production in the mitochondria of heart muscle cells. Vitamin K2 has been shown to support vascular elasticity because the biochemicals that utilize vitamin K2 as a cofactor, are able to remove calcium from plaque formations and move it back to the bones for better mineralization and bone strength.

100% of Subjects Evaluated Showed Improved Triglyceride Level Maintenance.

High triglyceride levels are an indicator that an individual consumes more calories in the form of carbohydrates than one burns. This excess sugar turns into a type of fat called triglycerides. High triglycerides contribute to hardening and thickening of the artery walls, which increases the risk of stroke, heart attack and cardiovascular disease. High triglycerides are also associated with inflammation of the pancreas.

High triglycerides are associated with obesity and metabolic syndrome, which includes the storage of visceral and body fat at the waistline, high blood pressure, high blood sugar and abnormal cholesterol levels. All of these are indicators for harmful health conditions.

To reduce harmful fats in the blood it is important to exercise, eat a diet low in carbohydrates and animal fat while consuming good fats such as olive oil, fish oils, avocados and nuts. Numerous studies in humans have shown that consuming Omega-3 fatty acids may be supportive to helping maintain healthy triglyceride levels.

FGF2 (fibroblast growth factor-2) in Laminine has been shown to support the function of pancreas cells. The amino acid profile in Laminine also contains amino acids shown to support pancreatic cells.

86% of Subjects Showed Improved Cortisol Level Reduction.

Cortisol is often called a stress hormone indicating that beyond its normal functions in your body, it can be harmfully and continuously elevated. If an individual encounters a perceived threat, such as a large dog barking, a region in the brain sets off an alarm system in the body. Hormones including adrenaline and cortisol are released to respond to this "threat."

Adrenaline increases the heart rate, blood pressure and boosts energy supplies as the body prepares to "fight or flea" the perceived danger. Cortisol increases sugars in the bloodstream to give the brain energy to respond and increases the substances for tissue repair. This is a good survival tool in an alarmed situation.

Higher cortisol alters the immune system, and suppresses the digestive, reproductive and growth systems. This complex natural alarm system also communicates with the brain regions that control mood, motivation and fear. Once the "threat" has passed, the adrenaline and cortisol levels return to normal restoring the heart rate and blood pressure to normal, while other body systems resume their original activities.

However, if stress is constantly present and an individual "feels" under attack, or fearful or worried constantly, then the "fight-or-flight" response stays turned on. This overexposure to cortisol and other stress hormones can disrupt most all body processes. This puts an individual at increased risk of many health problems, including:

	Anxiety	Heart disease
	Depression	Sleep problems
	Digestive problems	Weight gain
	Headaches	Memory and focus issues

In several preliminary human studies, Laminine consumption reduced cortisol levels. The primary growth factor in the LifePharm Growth factor extract, (FGF2) supports neurological responses in areas of the brain known to reduce anxiety, influencing good mental and emotional responses. Scientists are observing that these responses are occurring at the genetic or DNA level. They are also observing that individuals who have suffered long-term, high stress conditions show greater deterioration of the DNA protective strands called Telomeres than normal people. A clinical study showed that subjects consuming Laminine (4 capsules/day) for ninety days had activated the DNA repair mechanism (telomerase enzyme) which restores telomere integrity and length. This is associated with better cell division or proliferation giving rise to restored tissues leading to healthier aging. High stressed individuals that care for a spouse with Alzheimer's disease, mothers raising handicapped children and combat war-veterans have shown in published studies to have shorter telomere length compared to matched control subjects.

Summary:

Previously reported clinical and basic research studies ascertained that the Lifepharm dietary supplement formulas have nutritional ingredients that support helpful functions in the body. Providing all supplements in an inclusive convenient package encourages their regular daily consumption. It is noteworthy to observe beneficial clinical outcomes and safety occurring with use of all the supplements taken daily for ninety days.

Supporting cellular benefits and regeneration functions with the Laminine product is of great benefit to general repair and regeneration of healthy cells. An earlier study showed cholesterol and triglyceride lowering effects when both Laminine and Omega+++ were taken together rather than when OMEGA+++ was taken alone.

When Immune+++ was taken by subjects there was benefit to supporting an increase in total white blood cells, B cells and T cells in a previous pilot study. When taken with Laminine the effect was even greater showing that immune cells seemed to respond well with the IMMUNE+++ product but there was an enhanced effect when Laminine and IMMUNE+++ were taken together.

We also know the digestive system is key to optimal health in balancing proper digestive functions, and key to the immune system functions. Digestive+++ has been studied showing its benefit in improving the gut lining important for deterring pathogens or cellular by-products such as gluten, allergens or undigested food particles from leaking into the blood stream.

It is noteworthy to observe that taking all supplements together two Laminine, one Digestive+++, one IMMUNE+++ and one OMEGA+++ daily would benefit numerous body functions. Observing a high response in the typical parameters that are generally used to check for overall health after consuming the REFIVE packet daily for 3 months is encouraging. This investigation warrants further studies with larger study groups.

Directions for adult use: Take one packet of enclosed supplements daily. Observe information on box about ingredients. Product contains fish and egg so avoid if you are allergic to these. As with all dietary supplements, if you are ill, pregnant or lactating consult with your physician before use.