Enzymes' new potential in an emerging wellness market

Wellness and self-medication are increasingly the focus of an ageing global population. Enzymes offer unique potential to enhance the action of pharma products, as well as correct innate age-related enzyme deficiencies, potentially delivering significant health benefits. Mark J Tallon, PhD, highlights the potential of medicinal categories of enzyme therapy, and confirms the place of enzymes as a legitimate sports-nutrition powerhouse

On a global level, the enzyme market is expected to rise 6.5 per cent annually to nearly $5.1 billion in 2009, according to market analyst Freedonia. Supplementation with enzymes has found uses across many categories, with digestive health being the most popular. However, its uses extend well beyond that of gut health, and include applications within the sports, joint-health and weight-loss markets. The following provides an overview of the evidence behind oral enzyme therapy and its latest uses.

Metabolic syndrome
Obesity, and its related conditions (prediabetic and metabolic syndrome), is a truly global problem with the search for both pharma and natural-product solutions high on consumers' lists. A recent study from the Giessen University Hospital (Germany) evaluated the influence of oral enzyme therapy on glucose metabolism in insulin-treated patients with diabetes mellitus.1

A total of 546 patients with diabetes requiring insulin treatment were screened for exocrine dysfunction (reduced enzyme secretion). Of these, 80 patients who entered the study were randomized to receive either pancreatin (39 patients) or placebo (41 patients) in a double-blind manner over a 16-week period.

Over the course of the study there were no significant differences between both groups concerning HbA(1c), fasting glucose levels. However, a reduction in mild and moderate hypoglycaemia was observed in the pancreatin group at the end of the study.1 This is in line with three earlier studies showing that the use of oral enzymes can help stabilize blood-glucose levels.

Given the body of evidence that exists regarding diabetic control with enzymes, the potential applications of pancreatin therapy are numerous. As with many products that have been shown to influence insulin and/or glucose levels in diabetics, enzymes may now find potential in the weight-loss segment.

Enzymes power-up immunity
As health scares such as SARS and the common cold/flu increase every year, the growth of dietary supplements directed at enhancing the immune system has also risen dramatically. Researchers from Turkey have carried out work that suggests supplementation with the enzyme serratiopeptidase may have immune-enhancing properties.2 Serratiopeptidase, an enzyme taken from silk worms, is one of the most researched enzymes currently available as a dietary supplement. In a recent study the use of serratiopeptidase was evaluated for its effectiveness in the eradication of a periprosthetic (knee-replacement) infection in an animal model.

Staphylococcus epidermidis is usually a nonpathogenic, bacterial infection and an important cause of infection in patients whose immune system is compromised, or who have indwelling catheters. In the current study two groups were given either serratiopeptidase enzyme injections into the knee joint in addition to antibiotic therapy for four weeks; or intra-articular saline solution injections together with the same antibiotic therapy. There was also a third, nontreatment group.2 After two weeks (the end of therapy), knee specimens were evaluated bacteriologically and histologically to determine the prevalence of persistent infection, and the effects of the enzyme on local tissue infection.

Microbiological testing suggested that infection persisted in only one (5.6 per cent) of 18 animals in the serratiopeptidase-and-antibiotic group, whereas it was present in six (37.5 per cent) of 16 animals in the antibiotic-only group. Histological evaluation showed similar results.2

The message of this study was that serratiopeptidase was effective for the prevention of Staphylococcus epidermidis and enhanced the actions of antibiotics. It will be interesting to see further research investigating the action of enzymes given orally on other bacterial infections in humans. Dietary supplements focusing on immunity, such as Cold-FX (CV Technologies) and Airborne (Knight-McDowell Labs), give some insight into the potential of immuno-enhancers. Whether enzymes go down this route, only time will tell.

Pharma gets natural
Over the past few years the merging of pharma and natural products has become more common. Heparin acts as an anticoagulant, preventing the formation of clots by allowing the body's natural lysis mechanisms to work. Heparin is currently used for anticoagulation conditions such as deep-vein thrombosis and pulmonary embolism. In a study from the University of Innsbruck (Austria), researchers evaluated the effect of the proteolytic enzyme papain on the bioavailability of heparin.3

Rats were orally administered 15mg tablets containing heparin (13 per cent), papain (64 per cent), and hydroxyethylcellulose (HEC)(22 per cent).3 Oral administration of tablets containing heparin/papain/HEC resulted in a sevenfold improvement of plasma anti-Xa activity in comparison to control (anti-Xa value indicates level of anticoagulation). Oral enzyme therapy resulted in relative bioavailability of 9.1 per cent vs subcutaneous injection.3 These results suggest that the co-administration of papain with heparin represents a new approach in improvement of absorption and bioavailability of orally administered heparin. Further research into the use of papain alone or with aspirin may provide novel opportunities.

Enzymes give you strength
In a previous issue I covered the application of enzymes to the speciality-sports channel and within a year of its publication we have a new study. Data published from research at the University of Nebraska-Lincoln examined the effects of a protease supplement on selected markers of muscle damage and delayed-onset muscle soreness.4

The study used a double-blinded, placebo-controlled, crossover-design trial, randomly assigning 20 males into either a supplement group (SUPP: 342mg of protease 6.0 and 340mg of protease 4.5 derived from Aspergillus oryzae) or a placebo group (PLAC: microcrystalline cellulose).4 Subjects began ingesting one dose of either the protease enzyme supplement or placebo on an empty stomach three times daily for three days.

Subjects were tested for isometric forearm flexion strength, relaxed arm circumference, subjective pain rating, and plasma creatine kinase activity and myoglobin concentration (chemical indicators of muscle damage).4 The testing occurred before; immediately after; and 24, 48 and 72 hours after a bout of eccentric exercise. During these tests, the subjects in the SUPP group ingested a protease supplement.4 The subjects in the PLAC group took microcrystalline cellulose. After testing at 72 hours and two weeks of rest, the subjects were crossed over into the opposite group and performed the same tests as during the previous visits but with the opposite limb.

Overall, forearm flexion strength was 7.6 per cent greater for the SUPP group than for the PLAC group. Other measures including biochemical analysis showed no significant differences.4 These findings provided further evidence that the protease supplement may be useful for reducing strength loss immediately after eccentric exercise, and for aiding in short-term strength recovery.

Wellness and ageing categories are integrally linked, and represent the growing shift toward targeting the 'boomer' population. The estimated expenditures on the US elderly by state health care are estimated to total some 23 per cent by 2075, up 15 per cent on current spending, according to a recent report by Business Insights.5 The enzyme market is well positioned to offer a significant number of products for the nutritional support of age-related ailments. Although at least one study of note indicates little effect of enzymes,6 many other studies not reported on within this article show beneficial applications for the supplements market.7,8,9 These new studies are proving efficacy for wellness and sports and exercise consumers, making enzymes a truly successful class of cross-category ingredients.

Mark J Tallon, PhD, receives royalties on the enzyme formulation Sorenzyme, manufactured by Labrada.

1. Ewald N, et al. Pancreatin therapy in patients with insulin-treated diabetes mellitus and exocrine pancreatic insufficiency according to low fecal elastase 1 concentrations. Diabetes Metab Res Rev. 2007 23(5):386-91.
2. Grabovac V, et al. Papain: an effective permeation enhancer for orally administered low molecular weight heparin. Pharm Res. 2007 24(5):1001-6.
3. Mecikoglu M, et al. The effect of proteolytic enzyme serratiopeptidase in the treatment of experimental implant-related infection. J Bone Joint Surg Am. 2007 88(6):1208-14.
4. Beck TW, et al. Effects of a protease supplement on eccentric exercise-induced markers of delayed-onset muscle soreness and muscle damage. J Strength Cond Res. 2007 21(3):661-7.
5. Tallon M. Dietary supplements: Outlook 2007. Market Report. Business Insights, Ltd, London.
6. Brien S, et al. Bromelain as an adjunctive treatment for moderate-to-severe osteoarthritis of the knee. Quarterly Med. 2006 99(12):841-50.
7. Beuth J, et al. Impact of complementary oral enzyme application on the postoperative treatment results of breast cancer patients - results of an epidemiological multicentre retrolective cohort study. Cancer Chemotherapy and Pharmacology 2001 47: S45-S54.
8. Brady MS, et al. An enteric-coated high-buffered pancrelipase reduces steatorrhea in patients with cystic fibrosis: a prospective, randomized study. J Am Diet Assoc. 2006 106(8):1181-6.
9. Vecht J, et al. (2006) Efficacy of lower than standard doses of pancreatic enzyme supplementation therapy during acid inhibition in patients with pancreatic exocrine insufficiency. J Clin Gastroenterol. 40(8):721-5.

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