Background

The underlying premise for taking a digestive enzyme supplement is the capacity for better nutrient absorption through enhanced digestion. NAFFA, LLC advocates this application for improving all aspects of health. A plethora of anecdotal and qualitative information is available to support the use of digestive enzymes. While we are convinced of the efficacy of fungal digestive enzymes, we have been lacking the quantitative information that would prove the same under disinterested scientific scrutiny. To achieve this goal, we embarked on a collaborative effort with TNO of the Netherlands to prove the efficacy of supplemental, fungal digestive enzymes for the digestion of food and absorption of nutrients.

The Netherlands Organization for Applied Scientific Research TNO (TNO Nutrition and Food Research) based in Zeist, Netherlands, is a reputable scientific organization whose mission is to be a link of knowledge between fundamental research and its applications to food, drugs and agrochemicals. To quantify the efficacy of supplemental enzymes, TNO proposed a series of experiments using a computer controlled dynamic gastrointestinal model (TIM). TIM is a unique patented technology, developed by TNO, that simulates the conditions of the human stomach and the small intestine. Using this technology, we accurately replicated the dynamic environment of the human stomach and the small intestine when food is being digested and absorbed. The stellar feature of this system is that it allowed for sampling at various times during the digestive process, which enabled us to gather information in real time about the extent of digestion and absorption of food under various conditions.

The protocols for TIM have been validated. The various studies that have been performed using TIM are well documented in literature (see ref. p.6).

The first step in this project was the formulation of a digestive enzyme blend that was generic, yet also effective. To this end, our enzyme formulator created a blend of fungal digestive enzymes that is the basis of our digestive enzyme product. In other words, we chose a basic blend of proteases, carbohydrates and lipases combined with their activating co-factor minerals. This blend was tested under two sets of conditions to observe digestibility and absorption of nutrients. The two conditions were perfect human digestion and impaired human digestion (explained in next section). The TIM system was fed a meal (standard FDA type) with and without our Health E80™ digestive enzymes. The extent of digestion was monitored by sampling nutrients (glucose and nitrogen) at various times and at different points in the GI tract.

Below is a graphical representation of the TIM system and the corresponding parts of the GI tract.

Figure 1. Schematic diagram of the dynamic, multi-compartmental model of the stomach and small intestine (TIM-1): A. gastric compartment; B. pyloric sphincter; C. duodenal compartment; D. peristaltic valve; E. jejunal compartment; F. peristaltic valve; G. ileal compartment; H. ileo-caecal valve; I. pH electrodes; J. gastric secretion bottles with acid and enzymes; K. duodenal secretion bottles with bile, pancreatin, bicarbonate; L. secretion of bicarbonate to control the intestinal pH; M. pre-filter system; N. hollow fibre semi- permeable membrane system; O. water absorption system; P. closed dialyzing system.

Study Protocol & Test

The study was performed in TNO’s dynamic, multi-compartmental system of the stomach and small intestine (TIM) as depicted in Figure 2. The model simulated very closely the successive dynamic conditions in the stomach and small intestine of healthy human adults with normal gastric and intestinal secretions and of human adults with impaired digestion due to lower levels of gastric and intestinal secretions. In other words, a perfect digestive system and an extremely impaired digestive system were chosen as test conditions. The two extremes were tested because the digestive capabilities of most humans fall somewhere in between. For each TIM run, 170 g of the standardized FDA-type of test meal (proteins, carbohydrates and fats) were mixed with 100 ml drinking water and 70 ml artificial saliva. Four different types of TIM experiments were performed in duplicate with this meal as follows:

meal without our Health E80 digestive enzyme blend under perfect digestive conditions.
meal with addition of Health E80 digestive enzyme blend under perfect digestive conditions
meal without our Health E80 digestive enzyme blend under 70% reduced gastric and intestinal secretion (impaired digestion)
meal with addition of Health E80 digestive enzyme blend under 70% reduced gastric and intestinal secretion (impaired digestion)

The secretion products of the human digestive system consisting of gastric juice with enzymes, pancreatic, bile and bicarbonate were added to the system at the appropriate times. The pH was monitored and maintained at physiological conditions and peristalsis was mechanically simulated. The gastric emptying and intestinal passage time were mimicked as per human conditions.

Figure 2. Schematic diagram of the dynamic, multicompartmental model of the stomach and small intestine (TIM-1): A. gastric compartment; B. pyloric sphincter; C. Duodenal compartment; D. peristaltic valve; E. jejunal compartment; F. peristaltic valve; G. ileal compartment; H. ileo- caecal valve; I. pH electrodes; J. gastric secretion bottles with acid and enzymes; K. duodenal secretion bottles with bile, pancreatin, bicarbonate; L.secretion of bicarbonate to control the intestinal pH; M. pre-filter system; N. hollow fibre semi-permeable membrane system; O. water absorption system; P. closed dialysing system.

Sampling and Analysis

Samples were collected over a 5-hour span at two points in the small intestine: jejunum (upper small intestine) and ileum (lower small intestine). The samples represented the extent of digestion during each of the test conditions mentioned above. Samples were collected using a method called dialysis, which closely approximates the absorption of nutrients through the lumen of the gut. Thus, only nutrients, and not undigested food, passed through and were collected as samples. Analysis of these samples for glucose and nitrogen content correlated directly with the extent of carbohydrate and protein digestion respectively in the GI tract.

Results – Perfect Digestive Conditions

The following graphs compare the digestion of carbohydrates and proteins under perfect digestive conditions, tested with and without the aid of the Health E80 digestive enzyme blend.

Results – Impaired Digestive Conditions

The following graphs compare the digestion of carbohydrates and proteins under impaired digestive conditions, tested with and without the aid of the Health E80 fungal digestive enzyme blend.

Discussion

The aim of the study was to determine the efficacy of the Health E80 digestive enzyme supplement on the digestibility of proteins and carbohydrates, and the bio-accessibility of nutrients under the following conditions:

Healthy human adult digestion (perfect conditions).
Impaired digestion. 70% reduced gastric and intestinal secretions.

Results show that Health E80 fungal digestive enzymes improve the digestibility and bio-accessibility of proteins and carbohydrates in the lumen of the small intestine, not only under impaired digestive conditions, but also in healthy human digestion. Furthermore, the test meal fed to the TIM system was an FDA recommended meal, which is smaller in macronutrient content and total calories than the typical American diet. The conservative amount of food used in the experiments, and the corresponding results obtained, further testify to the use of the Health E80 fungal digestive enzyme supplement.

The activity of any digestive enzyme supplement in the small intestine presupposes that the enzymes in the supplement survive the acidity of the stomach. From the above experiments, we have established that Health E80 fungal digestive enzymes do survive the acidity of the stomach and work in the small intestine. In fact, our research has demonstrated that Health E80 fungal enzymes not only survive the acidity of the stomach, but also are active in that harsh environment where other types of enzymes are inactivated. Therefore, there is no scientific basis for enterically coating Health E80 fungal enzymes for general digestive applications. Such action would be detrimental to the consumer since the coating would prevent the enzymes from working in the stomach.

Dr. Tracy Gibbs, PhD

NAFFA, LLC

This research is the first comprehensive study that shows that Health E80 fungal digestive enzymes substantially increase the level of digestion in the lumen of the small intestine and bio-accessibility of proteins and carbohydrates. These results not only validate the use of digestive enzymes in cases of impaired digestion, but also show that most healthy adults can benefit by using a digestive enzyme supplement.

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