Physician’s Desk Reference excerpts on Laminine Prescribing Information
Laminine® is moving forward with the PDR 2023 edition of the Prescriber’s Desk Reference (formerly Physician’s Desk Reference or PDR), which published a series of studies on the effects of Laminine with cellular repair, blood sugar, and telomere activities.
The latest clinical study on OMEGA+++, IMMUNE+++, and DIGETIVE+++ by Dr. Hitendra Shah, M.D., and Dr. Edward Andujar, M.D., conducted this study.
- Cholesterol Profile Study on Laminine Omega.
- Laminine Study on Blood Sugar Levels.
- Laminine on Wound Cellular Healing Activity.
- Laminine on Stress Hormone Cortisol.
- Effects of IMMUNE+++ on White Blood Cell Count.
- Effects of DIGESTIVE+++ on Gut Health.
- Laminine on Increased Telomere Activity.
REFERENCE: The PDR is considered the authority on prescription medications and alternative supplements and is used by more than 60,000 physicians in the United States every day. J.B. Spalding, Ph. D., a retired statistics professor from the University of North Texas, Denton, Texas, performed the statistical analysis.
1. Cholesterol Profile Study on Laminine Omega
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 in 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 the conclusion of week eight.
During this phase of the study, participants took 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 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.
Triglyceride and HDL levels
Triglyceride levels in Group A normalized by 267 mg/dl or 58.2 percent during Phase II, the most substantial change throughout 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 compared to Group C during Phase I. Nevertheless, for individuals with high triglyceride concerns, doubling the intake of Laminine and Laminine OMEGA+++ can yield a normalization in a short period.
These data suggest that Laminine OMEGA+++ helps to down-regulate cholesterol, LDL, triglyceride, and blood pressure levels (Group B). Still, 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.
2. Laminine Study on Blood Sugar Levels
A pilot study was undertaken to observe a possible trend of the effects of Laminine, a dietary supplement, on normalizing blood sugar levels in subjects beginning to experience unhealthy blood sugar levels.
Subjects’ Hgb A1c (hemoglobin marker for blood sugar levels) was assessed at the beginning of the study and after 12 weeks of taking two supplements daily. Eleven individuals participated in the study.
Metabolic syndrome often shows increasing levels of glucose intolerance. Measures to support persons who are overweight, have sedentary lifestyles, and are showing higher than normal glucose levels but are not classified as diabetic may benefit from taking Laminine.
Small groups, A, B, and C were created to measure changes. The study confirmed a significant difference between glucose levels before and after 12 weeks of supplementation with Laminine for Group B.
- Group A – Placebo
- Group B – Two capsules of Laminine
- Group C – Laminine + Medication
The difference in the Hgb A1c marker measurements before and after supplementation (a change of 0.475 units) was statistically significant in Group B, adding additional credence to the noted effect.
The statistical evaluation of Group C individuals taking medicines for normalizing high blood glucose levels illustrated the safety of the supplement as it did not interfere with medication or significantly alter the measurements as a group.
Laminine + Insulin
Noticeably, one participant in Group C had been taking insulin with Laminine at the start of the study. From the participant’s personal physician’s recommendation, tapered off the insulin and maintained stable blood sugar levels by the conclusion of the 12 weeks.
All participants in Group B experienced a normalized down-regulation in Hgb A1c levels, and three out of the four participants experienced a positive change in their status in Group C.
This preliminary evaluation shows the possibility that this supplement may have a beneficial effect on helping maintain normal blood glucose in subjects at risk for developing high blood glucose and warrants further study with a larger population.
3. Laminine on Wound Cellular 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 ten days. 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 growth factors such as growth hormone, insulin, or insulin growth factor (IGF-1).
They also postulate that the amino acid entry into the cell via peptide transporters may be more efficient for the stimulation of protein synthesis than an entry in the form of just amino acids.
Other possible mechanisms suggested by the authors for the increased wound healing with peptide versus nonpeptide 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.
Although proper dosage depends on the severity of the wound, generally, for post-surgery, 2 to 4 capsules is an ideal dosage. Based on user experience, the healing process shortened to about 30%.
Although no formal studies have yet been made, Laminine has also been found to help bone regeneration and increase its density, according to several users.
4. Laminine on Stress Hormone Cortisol
This study was designed to ascertain the efficacy of Laminine supplements on cortisol levels. During the experiment, 28 subjects, 16 women and 12 men, between 36 and 83, took part in the study.
The salivary cortisol level content of each participant was measured before they took part in the study. The salivary cortisol level was also measured every fifth day three times throughout the study when each participant’s intake amount was changed.
Cortisol “stress reduction” by 23.7%
A study shows a reduction of the stress hormone. 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 began on one capsule twice per day.
The total cortisol reduction by the end of the study was 27.3 percent in women and 19.2 percent in men.
Regular use of Laminine contributes to reduced stress beginning 12 days of intake.
According to nutritionist and biochemist Dr. Rena Davis, “We do explain (to her patients) that this is a protein supplement that helps the body cope with stress and pain and sleep. That it also assists the body in the absorption of minerals and other nutrients.”
Participants that initially started on a higher intake of Laminine saw their cortisol level reduced significantly over the first four days 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.
While the results of this study are encouraging, additional tests with a larger sample size are needed to validate the findings.
Laminine on depression
The root causes of depression are physical, mental, emotional, and even spiritual. These are manifested by how neurotransmitters called serotonin behave in the brain.
Serotonins are chemical substance that plays an important part in the regulation of learning, mood, sleep, and vasoconstriction (constriction of blood vessels). Doctors also conclude that serotonin plays a distinct role in anxiety, migraine, vomiting, and appetite.
Lysine, which is one component of Laminine’s complete amino acids, is known to regulate serotonin levels and may help with depression and anxiety.
5. Effects of IMMUNE+++ on White Blood Cell Count
Ten individuals participated in the study, divided into three groups: A, B, and C. Group A was on placebo. Group B took only IMMUNE+++, and Group C took IMMUNE+++ in concert with Laminine.
T-Cells and White blood cells
Natural killer cells, B cells, T cells, and overall white blood cells increased significantly during the 12 weeks, suggesting that IMMUNE+++ is even more effective when taken with Laminine.
Overall, the results in Group B and Group C suggest that IMMUNE+++ may help to boost the white blood cell count within the normal range.
When combined with Laminine, IMMUNE+++ increases the count within the normal range and is even more effective at supporting healthy immune function in individuals of various ages and genders.
Expectedly, individual results in Group A were mixed, but on average, all subjects experienced a downregulation in white blood cell levels. Group B results were positive overall, despite a down-regulation in natural killer cells in the group.
The results in Group C (one Laminine and one IMMUNE+++twice a day) were the most significant and encouraging despite the small sample size.
The study showed consumption of Laminine and IMMUNE+++ for 12 weeks significantly improved several types of white blood cell counts. LifePharm® Executive R and D Scientist Kimberly Lloyd M.S. presented the groundbreaking study at the American College of Nutrition (ACN) 57th Annual Conference in San Diego, California, last November.
6. Effects of DIGESTIVE+++ on Gut Health Integrity
Laminine® and DIGESTIVE+++ Supplementation Improve 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 four weeks. 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 coagulants. The product also includes a digestive enzyme blend to digest proteins (at various pHs), 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.
Increased Butyrate Production is Found to be Supportive of Colon Health
Butyrate has been studied for its role in nourishing the colonic mucosa. It is the substrate of choice for colonocytes to increase their healthy functioning.
Butyrate use by colonocytes has been indicated in the regulation of gross mutations in the mucosal cells’ DNA. It led to overgrowths of dysregulated cells, such as in the formation of tumors.
It promotes cell differentiation, cell-cycle arrest, and apoptosis of mutated colonocytes. A more significant increase in SCFA production and delivery, especially butyrate, to the distal colon has been shown to have a protective effect.
Butyrate Supports Normalized Inflammation Response in the Bowel
During the four-week study, an average 28% increase in butyrate production was shown in the subjects. The clinical indication of an increase in butyrate production supports normalized bowel inflammation.
Butyrate is the choice of fuel for the cells lining the colon. When cells lining the gut are adequately nourished and healthy, inflammation is regulated. It provides a more robust gut lining, which helps resist leaking and tears.
In specific imbalances of the colon and GI tract, butyrate has been shown to regulate markers of inflammation. People that experience bowel disturbances and irritation, including those with diarrhea, tend to have lower total SCFAs.
DIGESTIVE+++ contains the probiotic Bacillus coagulants, which remain intact during the digestive process because it is one of the only spore-forming lactobacillus types.
The protective spore helps keep the colonizing bacteria viable through digestion and has been shown in studies to remain in the colon as an effective probiotic.
When the gut is more optimally colonized with good probiotics, the gut lining is improved, gastrointestinal disturbances are minimized, and healthy bowel function is restored.
Supplementing with Laminine and DIGESTIVE+++ dietary supplements from LifePharm showed that Short-Chain Fatty Acids (especially butyrate for the colon) are being increased over a relatively short time.
The formula created by LifePharm for a probiotic, prebiotic, and digestive enzyme product was formulated with science-based trials evaluating each selected ingredient.
Taking DIGESTIVE+++ and Laminine as directed was shown to support optimal digestive tract and colon health.
The results evaluated differences in the collagen units from baseline and after six months of use of products. Statistical evaluations (related sample t-tests) showed a highly significant increase in collagen units for the group of 9 subjects and 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.
7. Laminine Study on Increased Telomere Activity
Over time the chromosome becomes less functional; the cap on its end, called the “telomere,” loses its ability to regenerate. Our DNA is not replicating the caps as it used when our bodies were much younger.
Each time a cell divides, telomeres are shortened. Telomere shortening plays a critical role in all aspects of aging and disease.
An increased telomerase activity may play a critical role in maintaining health and longevity.
Telomerase activity on lab test
We studied the effects of Laminine on skin cells in order to assess growth and repair (Figure 1) and used various concentrations of Laminine on skin fibroblast cultures.
After incubating cells for 1 week, the cytotoxicity test suggests that Laminine is not toxic to cells and can help maintain normal cell growth in vitro (Figure 1).
Telomerase activity in subjects
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.
Blood samples were taken from individuals on 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 in telomerase activity.
Laminine improves telomerase activity to repair telomeres and help delay early signs of aging. Hence, an antiaging food supplement.
When the telomeres begin to shorten, joint discomfort begins because of age-related inflammation.
Laminine, which contains FGF2 and amino acids, is an important supplement to help repair these chromosome caps, aiding joint pain by activating dormant stem cells naturally.
Laminine Food Supplement is not a drug or medicine and cannot be tested as such. Food supplements, in general, therefore, cannot claim any therapeutic claims, which is not to say the product does not work or influences the healing mechanism of the body. PDR reflects the summary of clinical studies that show Laminine can have therapeutic effects but does not necessarily claim it as a Pharmacology finding.
(3) Joseph-Silverstein, Jacquelyn, et al (June 1989) Basic Fibroblast Growth Factor in the Chick Embryo: Immunolocalization to Striated Muscle Cells and Their Precursors. The Journal of Cell Biology, 108: 2459-2466.
(4) Hatten, M. E., et al (1988) In Vitro Neurite Extension by Granule Neurons is Dependent upon Astroglial-Derived Fibroblast Growth Factor. Developmental Biology, 125:280-289.
(5; 7) Seed, Jennifer, et al (1988) Fibroblast Growth Factor Levels in the Whole Embryo and Limb Bud during Chick Development. Developmental Biology, 128:50-57.
(6) Gospodarowicz, D, et al (1986) Molecular and Biological Characterization of Fibroblast Growth Factor, an Angiogenic Factor Which Also Controls the Proliferation and Differentiation of Mesoderm and Neuroectoderm Derived Cells. Cell Differentiation, 19: 1-17.