Analysis of the efficacy, safety, and regulatory status of novel forms of creatine

Abstract

Creatine has become one of the most popular dietary supplements in the sports nutrition market. The form of creatine that has been most extensively studied and commonly used in dietary supplements is creatine monohydrate (CM). Studies have consistently indicated that CM supplementation increases muscle creatine and phosphocreatine concentrations by approximately 15-40%, enhances anaerobic exercise capacity, and increases training volume leading to greater gains in strength, power, and muscle mass. A number of potential therapeutic benefits have also been suggested in various clinical populations. Studies have indicated that CM is not degraded during normal digestion and that nearly 99% of orally ingested CM is either taken up by muscle or excreted in urine. Further, no medically significant side effects have been reported in literature. Nevertheless, supplement manufacturers have continually introduced newer forms of creatine into the marketplace. These newer forms have been purported to have better physical and chemical properties, bioavailability, efficacy, and/or safety profiles than CM. However, there is little to no evidence that any of the newer forms of creatine are more effective and/or safer than CM whether ingested alone and/or in combination with other nutrients. In addition, whereas the safety, efficacy, and regulatory status of CM is clearly defined in almost all global markets; the safety, efficacy, and regulatory status of other forms of creatine present in today's marketplace as a dietary or food supplement is less clear.

Improved Creatine Stability and pH Profile for Kre-Alkalyn

“…Only during the accelerated stability test was there a small indication of creatine to creatinine conversion at 0.055 after 150 days, the equivalent to 5 years of real time, and 0.1% after 180 days, the equivalent to 6 years of realtime. It has been established that creatine breakdown is a function of pH [2]. Using a systematic mock-up of a stomacher, described above, it was shown that Kre-Alkalyn maintained a significantly higher pH than traditional creatine, in three separate reagents tested.…”

“…Creatine (N-(aminoiminomethyl-N-methyl glycine) is an important energy producing amino acid based metabolite produced in the liver, kidneys, and pancreas and commonly used by the muscles [1][2][3]. Creatine in various forms is used as a supplement to increase athletic performance [4][5][6].…”

“…Yet its stored shelf life and half-life in the stomach play a role in its bioavailability after ingestion. Previous reports suggest that the degradation of creatine results from pH changes [2,8,9]. Indeed at normal physiological pH, 10% of creatine has been suggested to convert to creatinine, it's most common byproduct [10].…”

Creatine in health, medicine and sport: an introduction to a meeting held at Downing College, University of Cambridge, July 2010

“…There is a slight increase (within the normal range) of urinary methylamine and formaldehyde excretion after a high dose of Cr, although this is reduced when the dose is spread throughout the day (Kim et al 2011). The most commonly used form of Cr is creatine monohydrate (CrM) (Jäger et al 2011). Studies have shown that little or no CrM is degraded during normal digestion and that nearly 99% of orally administered CrM is either taken up by muscle or excreted in urine.…”

“…These newer forms have been purported to have better physical and chemical properties, bioavailability, efficacy, and/or safety profiles than CrM. However, there is no evidence that any of these are more effective and/or safer than CrM, whether ingested alone and/or in combination with other nutrients (Jäger et al 2011). Furthermore, the regulatory position of these newer forms is uncertain in many countries, whereas that for CrM is clear.…”