Reginator - An Exciting New Approach to Protein Supplementation
06/01/2018 - Product Newsletter #314
INTRODUCTION - THE INCREASING PROBLEM OF FINDING THE IDEAL SUPPLEMENTAL PROTEIN
As most of you know, since we began the development of the Moss Nutrition Professional Line in 2009, we have made it a high priority to meet your need for various protein-based meal supplement/replacement products that can be used for purposes ranging from detoxification to muscle building to general support. Therefore, during the last ten years we have developed products such as Select Cleanse, SarcoSelect, and Select Meal. However, a challenge that has persisted since we first started producing these products several years ago has been finding protein powders that would not pose a problem from either an allergenicity, digestibility, or toxicologic standpoint for the vast majority of your patients.
Traditionally, the professional supplement industry's answer to this challenge has been the use of rice protein because it tended to be hypoallergenic and highly digestible for the vast majority of patients no matter what the level of GI function or symptomatology. Unfortunately, several years ago we began to learn about some highly disturbing toxicologic information about rice protein in relation to arsenic. The paper "Arsenic in rice: A cause for concern" by Hojsak et al (Hojsak I et al. J Pediatr Gastroenterol Nutr, Vol. 60, No. 1, pp. 142-145, January 2015) provides some sobering details about the rice/arsenic connection. First, consider the following:
"...the concentration of inorganic arsenic is high in rice and can reach 90% of the total arsenic content. The concentration varies according to the soil where the rice was cultivated and the type of rice. The high arsenic concentration in rice compared with that in other grains reflects the anaerobic growing conditions of flooded rice paddies and the unique physiology of the plant that allows it to take up and sequester arsenic from the environment, accumulating it to a greater extent than the soil."
Specifically, what is the arsenic content of rice? The authors continue:
"The arsenic content of raw rice varies from 0.1 to 0.4 mg of inorganic arsenic/kg of dry mass. Rice has a much higher level than that in other grains such as wheat and barley, for which the reported total arsenic content is 0.03 to 0.08 mg/kg."
Next, Hojsak et al discuss other factors that affect arsenic content:
"...brown rice contains higher concentrations than white rice. Moreover, changes in arsenic content may occur during preparation of food in which cooking water seems to be of special importance; cooking rice in uncontaminated water can reduce the arsenic content of the rice.
Most of the inorganic arsenic in rice is concentrated in the bran layers that contain 10 to 20 times higher concentrations than whole grain."
With the above in mind, having been aware of the rice/arsenic relationship for several years, we have never used rice protein in our powdered, meal supplement/replacement products.
What about whey? Fortunately toxicologic concerns have never been an issue since we have been able to locate whey powders derived from pristine herds in New Zealand. Furthermore, given the large volume of positive clinical research on whey in terms of improvement of muscle mass, immune function, glutathione production, and over well-being, it has traditionally been an excellent choice for products such as Select Meal® and SarcoSelect®.
Unfortunately, over the years, more and more of you have been reporting that your chronically ill patients are experiencing increasing difficulty with digestion and allergenicity in relation to our whey-based products. Therefore, several years ago, because of positive information from a toxicology, digestibility and allergenicity standpoint, we started introducing pea protein-based versions of Select Meal® and SarcoSelect®. In addition, our cleanse product, SelectCleanse®, was produced with pea protein. Finally, we introduced Organic Select Pea Vanilla and Unflavored products. For a while this seemed to be the ideal solution from a toxicology/digestibility/allergenicity/efficacy standpoint. However, with more popularity and increased long-term use, increased issues of digestibility have been reported by many of you over the last 1-2 years. Furthermore, we have started to get a small but significant amount of reports about allergenicity with pea protein ingestion that we never received when we first began to introduce the pea protein-based products.
With the above in mind, we began to see the handwriting on the wall, so to speak. It appears that, for many patients, the increased use of any protein powder due to convenience, taste, and efficacy, will all too often lead to overuse and inevitable development of digestion and allergenicity issues. After pondering this quandary for a while and examining the literature for answers, I came up with the obvious solution - products with a free-form amino acid base.
WHY ARE MORE PATIENTS REACTING TO DIFFERENT PROTEIN POWDERS?
I found the answer to this question in research papers that were looking for solutions for infant feeding for those infants who could not tolerate either breast milk or traditional, cow's milk-based formulas. In these papers it was noted that many infants who could not tolerate either breast milk or cow's milk-based formulas easily tolerated a whey-based formula where the whey is similar to what is used in the Moss Nutrition products. In the research papers these formulas are referred to as "extensively hydrolyzed formulas (eHF)." However, there was a small but very significant infant population, similar to what you are seeing in adult populations, who could not tolerate eHF formulas. The incidence of eHF intolerance and the reason was discussed by Hill et al in their paper "The efficacy of amino acid-based formulas in relieving the symptoms of cow's milk allergy: a systematic review" (Hill DJ et al. Clin Exp Allergy, Vol. 37, pp. 808-822, 2007):
"Studies suggested that 2-10% of infants with uncomplicated cow's milk allergy may be intolerant to eHF, rising to 40% in pre-term and term infants with more complex forms of the disease."
Therefore, as many of you have been suggesting, intolerance to whey-based formulas is becoming a significant issue. Is there any way to predict which patients might be more sensitive to protein powders? Hill et al state:
"Many of these infants with intolerance to eHF suffer from multiple food allergy."
As all of us know all too well, more and more patients are demonstrating intolerance to more and more foods. As suggested in the above quote, these patients are more likely to be reactive to protein powder-based formulas.
What is the mechanism of this increased reactivity? The authors suggest:
"...slowly evolving reactions to eHF are likely to be T cell mediated and triggered by residual T cell epitopes in hydrolysed formula. Intolerance to these relatively minor residual antigens in eHF or breast milk is consistent with underlying impairment of low dose tolerance, a regulatory mechanism dependent on the cytokine TGF-β. In support of this, impaired generation of duodenal TGF-β producing lymphocytes has been demonstrated in infants with allergy to cow's milk and other antigens."
Of course, the key point in the above quote, which is no surprise to the vast majority of you, is the suggestion that intolerance to protein powders and other foods in general may have its origins with suboptimal GI function. Therefore, while avoidance may be the most practical solution in the short term, it is far from ideal in the long term, particularly from a patient compliance and quality of life perspective. Therefore, in my opinion, avoidance only makes sense when it is accompanied with efforts to optimize gut function so that requirement for sometimes restrictive, socially challenging avoidance diets will be of as short a duration as possible.
The paper "Hypoallergenicity and efficacy of an amino acid-based formula in children with cow's milk and multiple food hypersensitivities" by Sicherer et al (Sicherer SH et al, J Pediatr, Vol. 138, pp. 688-93, 2001) provides further insight about the issue of reactivity to several different forms of protein powder:
"Food allergy affects 6% to 8% of young children, and the prevalence appears to be rising. Treatment of young children with a food allergy or older children with multiple food allergy requires the use of nutritionally balanced formulas to maintain adequate growth. Traditionally, soy-based formulas and protein hydrolysates, such as casein hydrolysates, have filled this need. However, a subgroup of children are reactive to these formulas because of soy allergy or reactions to residual protein in hydrolysates. This is particularly an issue for children with allergy that is not directly related to food specific IgE antibody, such as enteropathy, enterocolitis, proctocolitis, and allergic eosinophilic gastroenteritis."
Before continuing, please note again in the above quote that reactivity to protein powders in many patients is not based on the traditional, hard-wired IgE-mediated food allergy we learned about in basic sciences. Rather, as suggested above, it is a downstream effect of poor gut function. Therefore, as I also suggested, whether or not actual GI symptoms are expressed, patients who are intolerant to several different protein powders should undergo a comprehensive GI evaluation to truly understand the nature of the problem and arrive at solutions to improve food tolerance.
AMINO ACID-BASED FORMULAS: THE ANSWER TO PROTEIN POWDER INTOLERANCE
As noted in the Hill et al paper, individuals with uncomplicated food allergy scenarios tend to do equally well with protein powder- or amino acid-based formulas:
"Evidence form head-to-head randomized controlled trials shows amino acid formulas and eHF are equally effective in resolving GI and skin symptoms in uncomplicated cow's milk allergy."
However, in those patients mentioned above who seem to be reactive to several foods, results were much better with amino acid-based formulas compared to eHF:
"The controlled trials identified an important group of infants with suspected cow's milk allergy and intolerance to eHF who responded favourably to amino acid formulas."
Similar results were reported by Sicherer et al concerning patients with multiple food allergies:
"A formula based on free-L-amino acids...was previously shown to be tolerated in this group of patients, even when hydrolysates were not.
Given that more and more patients are demonstrating multiple food sensitivities and ever increasing reactivity to protein powders no matter what their source, we at Moss Nutrition will be introducing more and more amino acid-based versions of our protein powder-based products over the next few years. This will include the following four products:
· Select Meal® Chocolate & Vanilla
· Select Cleanse®
INTRODUCTING REGINATOR® A SUPERIOR AMINO ACID FORMULATION
For perspective, it must be kept in mind that the above discussion took on a "glass half empty" stance on protein powders by focusing on the immunoreactivity and intolerance issues. The glass half full stance is that protein powders such as whey and pea possess outstanding anabolic, muscle building, and tissue repair properties. Therefore, in creating amino acid-based versions of the above products it was imperative for us to find an amino acid formula with equal anabolic properties. Fortunately, the solution to this challenge was provided by Robert Wolfe, probably the premier researcher in the country today on anabolic uses of protein/amino acid supplementation, whose papers I have quoted frequently in my various newsletters over the years. Dr. Wolfe has created a unique blend of the nine essential amino acids plus arginine which goes by the name Reginator®. What is Reginator®? Please note the following from the Reginator® technical information we received:
"Reginator is a safe, unique patented combination of 9 essential amino acids plus arginine that has been clinically shown to significantly increase muscle protein synthesis at an efficacious dose of 3.6 grams per day. Reginator was developed and optimized over a 17 year timespan, in which 24 clinical studies were conducted. One of the key findings of the studies was that essential amino acids (EAAs) are required in a specific ratio and amount to help build new muscle tissue and assist with cell repair, which occurs when muscles are recovering."
What are the advantages of the amino acid blend in Reginator®? According to the technical information we received:
"1) The profile of EAAs inside proteins determines the rate of muscle protein synthesis. If the dietary protein has sufficient EAAs, the rate of protein synthesis can match or even exceed the rate of protein breakdown...Reginator was developed to optimize the exact ratio and amount of EAAs to activate intracellular initiation of protein synthesis while also providing all of the precursors necessary to produce complete proteins.
2) Reginator was formulated to optimize the performance of the EAAs in the body. Whereas too much of an amino acid can cause oxidation and lessen the effect of muscle protein synthesis, too little of an amino acid causes the body to steal or scavenge the required amino acid from muscle or organs. Over 20 years of research by Dr. Wolfe has perfected the amount and ratios of amino acids for optimal muscle protein synthesis for Reginator."
Does clinical research exist to support the use of Reginator®? Over the years, Dr. Wolfe has co-authored several research papers on the benefits of amino acid formulations. One paper, "Effect of amino acid supplementation on muscle mass, strength and physical function in elderly" by Borsheim et al (Borsheim E et al. Clin Nutr, Vol. 27, No. 2, pp. 180-195, 2008), evaluated the use of a formula very similar to Reginator® in twelve glucose intolerant patients aged 67.0 ± 5.6 years. The conclusion of this study was the following:
"Supplementation of the diet with EAA + arginine improves lean body mass, strength and physical function compared to baseline values in glucose intolerant elderly individuals."
OUR PLAN FOR INTRODUCING REGINATOR®
The first products we will be introducing using Reginator® will be Select Meal® Vanilla and Select Meal® Chocolate. We hope to have them available to you before the end of 2018.
We are excited to be introducing this whole new concept of hypoallergenic, highly anabolic meal supplement/replacement products to you and certainly look forward to your feedback.