Abstract : Functional dyspepsia (FD) is a highly prevalent disorder having nonspecific symptoms and varied pathophysiology. Its treatment remains a challenge as therapeutic options are limited, unsatisfactory, and elusive. Thus, safety and efficacy of DigeZyme, a proprietary multienzyme complex (MEC), was evaluated as a dietary supplement in FD patients. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 patients were randomly assigned (1:1 ratio) to receive either MEC (50 mg, TID; n = 20) or placebo (n = 20) for 60 days. Reports of adverse or serious adverse events (AEs), abnormal results of vital signs, abnormal findings during physical examination, and abnormal laboratory investigations were monitored closely. Efficacy measures were change in Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ), Nepean Dyspepsia Index-Short Form (NDI- F), Visual Analog Scale (VAS), Clinical Global Impression Severity Rating Scale (CGI-S), and Glasgow Dyspepsia Severity Score (GDSS) at baseline and follow-up visits on day 15, 30, and 60. Supplementation with MEC was associated with statistically significant differences (P value ranging from .0401 to .0033) in all efficacy parameters compared with placebo. The between-group comparison also revealed that MEC supplement had a significantly greater effect (P < .001) versus placebo. No investigation product-related AEs were reported. There were no clinically significant abnormalities in physical findings and no statistically significant changes in biochemical and hematological parameters, vital signs, body weight, and body mass index observed between the two groups at baseline and follow-up visits. MEC supplementation represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.
Keywords : digestive enzymes dyspeptic symptoms functional dyspepsia multienzyme complex nonulcer dyspepsia safety and efficacy
Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia:A Randomized, Double-Blind, Placebo-Controlled Study - Muhammed Majeed, Shaheen Majeed, Kalyanam Nagabhushanam, Sivakumar Arumugam, Anurag Pande, Mahesh Paschapur, and Furqan Ali - JOURNAL OF MEDICINAL FOOD J Med Food 21 (11) 2018, 1120–1128

Sabinsa's multi-enzyme complex DigeZyme®, a proprietary blend of non-animal sourced enzymes, was shown to have the potential for more rapid recovery from Delayed Onset Muscle Soreness (DOMS) in a study published in Sports Nutrition and Therapy: Multi−Enzyme Complex for the Management of Delayed Onset Muscle Soreness after Eccentric Exercise: A Randomized, Double Blind, Placebo Controlled Study.  
Delayed onset muscle soreness (DOMS) is one of the outcomes of inflammation due to microscopic wear and tear in the muscles caused by strenuous exercise. While some muscle soreness is typical of any exercise regimen and usually peaks around 36-48 hours after the exercise event, in athletes or even regular gym-goers unaccustomed or high intensity exercise may lead to sustained inflammatory response, causing prolongation of skeletal muscle recovery. DOMS may lead to passive stiffness, swelling and pain in muscles, which may affect performance as well as recovery.
In this prospective, double blind, randomized, placebo controlled trial on 20 healthy male subjects, the analgesic effect of DigeZyme in management of DOMS were compared to placebo. While DigeZyme’s role in supporting improved digestive health is well recognized, this is the first attempt to evaluate its role in DOMS resulting from muscle overload or strenuous exercise.
Supplementation with 50 mg of DigeZyme three times a day demonstrated significant improvement in both subjective pain and muscle tenderness after eccentric exercise. This study establishes the role of DigeZyme in sports nutrition, especially as a post exercise recovery supplement.
DigeZyme is available as a powdered blend which can be mixed with other sports nutrition ingredients as well commercialized as a standalone product.
"This new study, gives a new twist to a classic product of ours, DigeZyme," said Sabinsa Marketing Director Shaheen Majeed. "Well known for use in digestive health, we have now studied DigeZyme for this specific sports indication. Enzymes have been part of the sports supplements category, and DigeZyme has enjoyed its place in many sports products, mainly to have enzymes breakdown proteins and carbohydrates. Sabinsa has now given an additional clinical indication that no other enzyme blend has done before - DOMS. Our blend for this indication is now patent pending.". Study for Digezyme [SBDIGEZY]
Background: Delayed onset muscle soreness (DOMS) results from muscle overload or strenuous exercise that goes beyond the intensity or duration for which the muscle is accustomed to perform. It is accompanied with the sensation of pain, tenderness, deep ache, and stiffness in muscles that usually begins several hours after the unaccustomed exercise. The aim of this study was to compare the efficacy of multi enzyme complex with a matching placebo in reducing pain associated with DOMS induced by standardized eccentric exercise.
Methods: Twenty healthy males (10 pairs) were randomized in this double blind, placebo controlled trial to receive a placebo or multi enzyme complex capsule (50 mg) thrice a day for a period of 3 days. Mean differences within the group and between groups were assessed at each data collection time-point using Analysis of Covariance (ANCOVA) and Wilcoxon signed rank sum test for all outcome measures.
Results: In this controlled clinical study, intake of multi enzyme complex for 3 days resulted in no statistically significant changes in the descriptive statistics and efficacy analysis in muscle power and grip strength measured by hand held dynamometer. Algometer readings of thigh muscle showed statistical significance (p max 0.043). Decrements were observed in McGill Pain Questionnaire showing high statistical significance. Reducing trend was observed in bio markers of muscle damage (creatine kinase and lactate dehydrogenase) as well.
Conclusion: The study results suggest that compared to placebo, Multi enzyme complex supplementation improves the outcome measures related to DOMS induced by standardized eccentric exercise.
Multi−Enzyme Complex for the Management of Delayed Onset Muscle Soreness after Eccentric Exercise: A Randomized, Double Blind, Placebo Controlled Study, Majeed M, Siva KA,Shaheen M,Priti V and Kiran KV, Sports Nutr Ther 2016, 1:3

The three essential nutrients in food, i.e. carbohydrates, proteins and fats can be assimilated by our body only after being broken down to smaller digestible units. This work is done by various enzymes and compounds secreted by the lining of the digestive tract and the digestive glands in our body, such as salivary glands, the liver and pancreas. The digestive process starts with action of salivary amylases which injected with saliva to the mouth start breaking complex sugars, like vegetable starches, into smaller sugar units. The food is then moved to the stomach where it is subjected to enzymatic action of protein digesting enzyme pepsin, secreted by specialized stomach cells called chief cells or zymogenic cells. Subsequently, the stomach content is transported by a peristaltic movements of digestive tract to small intestines. It is there that pancreatic juice is delivered together with bile secreted from the liver via the gallbladder to facilitate further digestion of sugars, proteins and, importantly, digestion of the dietary fats. The corresponding enzymes, i.e. pancreatic amylase, carboxypeptidase and lipases are provided in pancreatic juice. Fats are hydrolyzed by the pancreatic lipase into free fatty acids, and by the action of bile salts they are transformed into micelle, i.e. the form of dietary fats that are absorbed by cells of the gastrointestinal tract.
DigeZyme
Commercially, digestive enzymes are isolated from various sources such as the pancreas of higher animals (swine and cattle), higher vegetables (barley), and microorganisms including bacteria and fungi. The multi-enzyme complex DigeZyme consists of GMO-free broad acting enzymes obtained from the fermentation process with Aspergillus oryze, including amylase, protease and lipase; this group of enzymes breaks carbohydrates, proteins and fats and all three groups of enzymes are resistant to the action of gastric juices, while retaining their digestive activity. DigeZyme is referenced in The Complete Book of Enzyme Therapy by Anthony J. Chichoke (Ref. 1). DigeZyme was also clinically evaluated for enhanced absorption of minerals and vitamins.
Enzymes are catalysts which participate in virtually every bodily process and, as previously discussed, their shortage can cause an illness. The profound effect of enzymes on the body can be illustrated by the German study of karate fighters using enzymes before fighting. The group that took enzymes showed recovery from fight related injuries in 7 days while the placebo group recovered in 16 days. This study shows a direct link between ability of the body to regenerate and a sufficient presence of the digestive enzymes in the body.
Intelligent Nutrient in support of body functions in health and disease - Article of 6 pages / Digezyme, Vladimir Badmaev, MD PhD, Muhammed Majeed, PhD