PDR – Study Highlights

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physicians desktop reference

Highlights from the Physicians Desk Reference

Effects of LAMININE on 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 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.

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, the 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.

Effects of LAMININE on Normal 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) were assessed at the beginning of the study and after 12 weeks of taking two supplements daily. Eleven individuals participated in the study. Three subjects took a placebo, four subjects with slightly higher than normal Hgb A1c levels took two Laminine daily. Four subjects who were on blood sugar lowering medications that had been previously prescribed for them took two Laminine daily.

Conclusion

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, could possibly benefit from taking Laminine. Although the sample size was small, this preliminary investigation did show a significant difference between glucose levels before and after 12 weeks of supplementation with Laminine. The difference in the Hgb A1c marker measurements before and after supplementation (a change of 0.475 units) was also statistically significant in Group B, adding additional credence of the noted effect. This preliminary evaluation shows the possibility that this supplement may have a beneficial effect towards helping maintain normal blood glucose in subjects at risk for developing high blood glucose and warrants further study with a larger population.

The statistical evaluation of Group C individuals, taking medicines for normalizing high blood glucose levels, illustrated safety of the supplement as it did not interfere with medication or alter significantly the measurements as a group. Only one subject showed a higher rather than lower effect while on the supplement. Noticeably, one participant in Group C had been taking insulin with Laminine at the start of the study, and per this participant’s personal physician’s recommendation had tapered off 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 levels in Group C.

It is known that nine-day fertilized avian egg extract that is not denatured with heat processing could retain fibroblast growth factor (FGF) activity. Because growth factors react with receptor sites on somatic cells or stem cells, this activity could support glucose absorption. Laminine also contains fish and vegetable protein, which may have an effect on glucose tolerance when added to the diet continuously. Continuing studies are warranted on clinical effectiveness and also on the mechanism of action of Laminine.

J.B. Spalding, Ph. D. retired statistics professor from the University of North Texas, Denton, Texas performed the statistical analysis.

Effects of LAMININE+++ and LAMININE on Cholesterol

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.

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.

Effect of IMMUNE+++ and LAMININE on normal white blood cell count levels

The study was designed to test the effects of LifePharm IMMUNE+++, independently and in combination with Laminine on total white blood cell (lymphocyte) count, which includes natural killer cells, B cells, and T cells. This was a placebo-controlled study that took place over a 12-week period.

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.

Conclusion

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. Natural killer cells, B cells, T cells and overall white blood cells increased significantly during the 12-week period, 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+++ boosts the count within the normal range and is even more effective at supporting healthy immune function in individuals at a variety of ages and genders.

J.B. Spalding, Ph. D. retired statistics professor from the University of North Texas, Denton, Texas performed the statistical analysis.

Effect of DIGESTIVE+++ and LAMININE on gut health and integrity

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.

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 leading 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 greater 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 properly nourished and healthy, inflammation is regulated. This provides a stronger integrity of the gut lining, which helps resist leaking and tears. In certain 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 coagulans which remains intact during the digestive process because it is one of the only spore-forming lactobacillus types. The protective spore helps to 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 an indication that Short-Chain Fatty Acids (especially butyrate for the colon) is 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 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.

References

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4. Nordgaard I, Hove H, Clausen MR, Mortensen PB. Colonic production of butyrate in patients with previous colonic cancer during long-term treatment with dietary fiber (Plantago Ovata seeds). Scan J Gastroenterol, 1996, 31;10:1011-20.
5. Medina V, Afonso JJ, et al. Sodium butyrate inhibits carcinoma development in a 1,2-dimethyl hydrazine-induced rat colon cancer. JPEN J Parenter Enteral Nutr, 1998 Jan;22;1;14-7.
6. Rombeau JL, Kripke SA. Metabolic and intestinal effects of short-chain fatty acids. JPEN J Parenter Enteral Nutr 1990;14(5):181S-4S.
7. Roediger WE. The starved colon—diminished mucosal nutrition, diminished absorption, and colitis. Dis Colon Rectum 1990;33(10):858-62.
8. Scheppach W. Bartram, HP, Richter F. Role of short-chain fatty acids in the prevention of colorectal cancer. Eur J Cancer 1995 Jul-Aug;31A(7- 8):1077-80.
9. Smith JG, Yokoyama WH, German JB. Butyric acid from the diet: actions at the level of gene expression. Crit Rev Food Sci Nutr 1998 May;38(4):259-97.
10. Segain JP, et al. Butyrate inhibits inflammatory responses through NFkappaB inhibition: implications for Crohn’s disease. Gut 2000;47(3):397-403.

DISCLAIMER: 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. Results will vary depending on the facts and circumstances of each person.

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