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Bioclinic Naturals ElementAll Diet Technical Information

Overview:

1. The Elemental Diet

2. Elemental Diet Protocols

3. Research Summary

4. References

 



1. The Elemental Diet

Elemental diets (EDs) have been around for over 50 years, yet few recognise what they are and their importance in clinical practice.1 A review of the scientific literature reveals robust data validating the use of elemental diets for the dietary management of patients with limited or impaired capacity to digest, absorb and/or metabolise foods.1  The conditions referenced in the literature on elemental diets were initially confined to inflammatory bowel disease (IBD), Crohn’s disease (CD)2,3 and inflammatory ulcerative colitis (UC).4-7 However evidence is now suggesting that elemental diets can also help with small intestinal bacterial overgrowth (SIBO)8,9 irritable bowel syndrome (IBS)10 and other conditions that manifest outside the gastrointestinal system.11-22

A study appearing in the Journal of Paediatric Gastroenterology and Nutrition showed that an ED was as effective as corticosteroids in treating children with acute CD. In fact, it was concluded that the ED was a preferred therapy for these children as there were none of the side effects associated with steroid use.3 Interestingly, even with the data and supportive literature, very few utilise EDs for such conditions. One possible reason is the palatability of EDs, creating poor compliance. However, there are now available EDs that address this issue to drive patient compliance.

What is an elemental diet?

As the name suggests an elemental diet (ED) is a “basic” medical food that contains all the daily recommended allowances for essential fatty acids, vitamins, minerals and other nutrients required by the body for proper physiological functioning. An ED can also be described as similar to a meal replacement for the day, however there is one major distinguishing characteristic: it has no whole proteins, instead featuring pure, free-form amino acids. This allows the ED to be absorbed into the bloodstream within the first two feet, or proximal part, of the small intestine; an almost immediate assimilation.

This immediate absorption is possible because the ED consists of individual, essential, dietary compounds in their simplest forms, rendering the bulk of digestion unnecessary. The outcome is that it prevents food particles from reacting with the majority of the gastrointestinal tract, thus reducing many of the symptoms associated with various gastrointestinal conditions. However, this is not the only advantage to utilising the ED. There are many other key effects that result from an easy absorption of, and lowered reactivity to food, which are detailed in the sections below.23

Mechanisms of Action

Elemental diets have numerous applications, with continued research on its effectiveness. The trials on EDs are impressive, however it is also the work and clinical experience of health care practitioners that is confirming and expanding these very applications. While it hasn’t been fully elucidated how an ED works, there are a number of proposed mechanisms of actions with supportive scientific literature that are outlined below:

1. Improvement of nutritional status

Elemental diets have been shown to support the uptake of essential nutrients, correct negative nitrogen balance and improve poor nutritional status and support growth of irritable bowel disease (IBD) patients. It is thought that elemental diets may also improve omega 3 to omega 6 ratios, promote iron storage, improve bone remodelling and increase muscle mass of patients with IBD.25

2. Reduction in the production of gastric acid, pancreatic enzymes and bile, all leading to a decrease in epithelial loss.

Elemental formulas slow down the emptying of the stomach, concomitantly reducing acid secretion and the release of pancreatic enzymes. This is because the volume of ingested food by itself activates mechanoreceptor responses, which in turn activate neuronal negative feedback loops. A lower volume will activate a signal to decrease the acid secretion. When the formula is sipped or infused at a slow rate, the mechanoreceptor responses may be decreased. Enteral nutrition provides obvious caloric nutritional support and is trophic (either directly or through neuronal loops) for the intestinal epithelial compartment, an effect likely to be beneficial, especially for ulcerative colitis (UC).1,25-27

3. Decreases free radicals.

Elemental diets (EDs) decrease free radicals by increasing nutritional and therefore antioxidant status.28

4. Gives the gastrointestinal tract (small intestine) a rest.

The ED is thought to rest the gastrointestinal tract by reducing the workload of digestion and absorption and in peristalsis, allowing the promotion of epithelial healing.25-27

5. Decreases antigenicity.

The decrease of total fat and elimination of whole proteins may lower the antigenicity in the intestinal lumen, thereby reducing inflammation of the gastrointestinal tract. Improved nutritional intake and status may also limit luminal antigen exposure and allow improvement of barrier function.25

6. Improvement of the microbiome composition.

This leads to a reduction in pathogenic bacteria and malabsorption in irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD), such as Crohn’s disease (CD) patients. In IBD the proportion of Firmicutes is decreased, whereas the fraction of Proteobacteria and Actinobacteria is increased. Enteral nutrition has low residue and contains important prebiotic properties, which modify the gut microflora. Thus, it is plausible that the elemental diet affects gut microbiota composition by changing faecal metabolic activity. Various studies also indicate that enteral nutrition reduces intestinal permeability via modulation of tight junctions and down-regulates the production of inflammatory cytokines by modulating the intestinal microbiome. Elemental diets target gut microbiota as well as inflammation; in addition to suppressing NF-κB levels (a critical regulator of inflammation), they significantly lower the population of Bacteroides fragilis, a species linked to IBD as well as colorectal cancer.

One study on patients with CD revealed that the success of elemental diets in children with active small bowel/colonic CD was associated with an anti-inflammatory short chain fatty acid (SCFA) pattern, further suggesting the importance of elemental diet dependent microbiome changes. Furthermore, a clinical trial on patients given the ED for two weeks showed that the lactulose breath test (LBT) was normalised in the majority of IBS patients, who initially showed an abnormal breath test. This indicated that the ED could drastically improve enteric flora composition and confirmed its efficacy in a clinical setting. Another clinical trial on patients with CD supports this by showing a normalisation of their lactulose/L-rhamnose permeability ratios, coinciding with improvement of their clinical symptoms.10, 25,28,34-36

7. Decreased intestinal permeability.

Susceptibility to CD and IBD has been linked to genetic polymorphisms, leading to Paneth cell dysfunction or defective autophagy. This results in bacteria in the gut that would normally be non-pathogenic being allowed to adhere, translocate and penetrate the epithelial barrier, that has already been partially broken down as a result of an inflammatory diet. Persistent exposure to these bacteria will then trigger an adaptive immune response which gives way to inflammation and further breakdown of the epithelium. Therefore more migration and sensitisation to these bacterial species results. As a consequence of this, a vicious bacterial penetration cycle ensues.

An ED is thought to decrease the exposure to offending dietary components and subsequently decrease the penetration of harmful bacteria. An ED may also remove certain dietary agents (usually processed/industrialised foods), affecting microbial composition and decreasing inflammation, as well as promoting the restitution of the epithelial barrier. Both of these suspected mechanisms of action lead to breaking the disease-forming, bacterial penetration cycle. As a result, intestinal permeability and inflammation from the microbiome are significantly reduced.25-27,33

8. Decreased inflammatory response.

It is well known that cytokines are key in the regulation of the intestinal immune system and therefore mucosal inflammation. It has been shown that the proinflammatory cytokines such as interleukin (IL)- 1β, IL-6, IL-8, tumor necrosis factor (TNF)-α, and anti-inflammatory mediators like IL-1 receptor antagonist (IL-1ra), are increased in IBD. The ED plays a role in decreasing the antigen load and therefore effecting a decrease in intestinal inflammation.

However recent studies have suggested there may also be an effect on the actual production of mucosal pro-inflammatory and anti-inflammatory cytokines. Studies have shown that patients with existing IBD, when placed on an elemental diet for 2-4 weeks exclusively, had increased levels of vascular endothelial growth factor (VEGF) and transforming growth factor-beta 1 (TGF-β1). Whereas concomitantly the levels of IL-1β, IL-8, IL-1ra, IL-6, TNF-α and interferon-γ were reduced.

These studies also showed that the ED reduced production of mucosal cytokines and apparently corrected an imbalance between pro-inflammatory and anti-inflammatory cytokines in these patients. Simultaneous endoscopic and histologic healing of mucosal inflammation was associated with a decline in mucosal inflammatory cytokines. Hence, the ED appears to exert remarkably strong immune system attenuating effects.25-27

9. Stimulation of the Migrating Motor Complex (MMC), a key in moving bacteria out of the small intestine and into the colon between meals.

One of the most common underlying causes of SIBO is the impairment of the migrating motor complex (MMC). The MMC corresponds to cleansing waves activated approximately every 45-180 minutes in the small intestine to prevent the accumulation of debris and excessive amounts of bacteria. Pimentel et al. found that the MMC is decreased by 70% in SIBO patients. Apart from snacking, stress also negatively impacts the MMC. By implementing the elemental diet, the MMC can be restored to 50% of its capacity. This is because the elemental diet is absorbed in the first two feet of the small bowel, meaning that it leaves the rest with no food. The elemental diet therefore literally starves 80% of the bacteria in the small intestine, significantly reducing the bacterial load.10, 26, 27

10. Restoration of mesenteric adipose tissue.

Mesenteric adipose tissue (MAT) plays an important role in the pathogenesis of CD. It is well known that mesenteric fat hypertrophy, fat wrapping and creeping fat in patients with CD is highly typical. A study by Feng et al. evaluated the effects of EN on CD patients, with a focus on MAT alterations, such as adipocyte size and adipokine production. They showed that the elemental diet ameliorated mesenteric fat alteration in IBD, apparently by restoring adipocyte morphology and diminishing the inflammatory environment of the mesenteric fat.37

There is a plethora of simultaneous mechanisms of actions that may be occurring as a result of the ED. It is not only the improved nutritional status of patients, but also an improvement of the epithelial barrier, reduction of antigenic load and counteraction of dysbiosis, whilst intestinal immunity and adipose compartments are also directly affected. More studies need to be conducted to confirm these proposed mechanisms, however so far all have been extremely promising.

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2. Research Summary

There have been numerous studies that have validated the effectiveness of an elemental diet (ED), improving the symptoms of not only Crohn’s disease (CD),2,3 but a number of other conditions that include both irritable bowel syndrome (IBS)10 and small intestinal bacterial overgrowth (SIBO).8-10

Studies have also shown that elemental diets can improve immunoglobulin levels,27 eradicate pathogenic gut bacteria better than antimicrobials,25 be as effective as corticosteroids in acute CD3  and even have an effect on rheumatoid arthritis.20

In 2004 Pimental et al. published a retrospective study on 93 patients demonstrating that an ED had 80% efficacy in treating the symptoms of SIBO and IBS. Pimental found that patients had not only improved symptoms, but also showed normalised lactulose breath tests (LBTs) post the ED.10

Below is a summary of some significant clinical trials that show the efficacy of the ED against the various conditions mentioned above:

Crohn’s Disease

Heuschkel RB, 20003

Randomised clinical trials comparing exclusive enteral nutrition with corticosteroids were identified. Two independent reviewers extracted data from selected studies. Studies were assessed for heterogeneity and relative risks for remission induction with enteral nutrition were obtained. Sensitivity analyses were performed in partially randomized studies. Estimates were made of the number of studies needed to overturn the current result. Other outcome measures were qualitatively assessed.

In five randomised clinical trials comprising 147 patients, enteral nutrition was as effective as corticosteroids at inducing a remission (RR = 0.95 [95% confidence interval 0.67, 1.34]).

Crohn’s Disease

Tagaki S, 200932

Fifty-one CD patients in remission were randomly assigned to a half-ED group (n=26) or a free diet group (n=25). The primary outcome measure was the occurrence of relapse during a 2-year period. This time, we investigated the QOL of the patients and medical costs of half-ED, as secondary outcomes. QOL was evaluated using the Japanese version of the IBDQ scoring system, and medical costs were calculated monthly from the receipts.

IBDQ score was not significantly different between the two groups at 1 and 13 months after the start of maintenance treatment. Medical costs were not significantly different between them either. This study showed that half-ED therapy did not affect the treatment of CD patients, neither regarding their QOL nor medical costs.

IBS and SIBO

Pimental M, 200410

In this study, we evaluate the ability of an elemental diet to normalise the lactulose breath test (LBT) in IBS subjects with abnormal breath test findings. Consecutive subjects with IBS and abnormal LBT suggesting the presence of bacterial overgrowth underwent a 2-week exclusive elemental diet. The diet consisted of Vivonex Plus (Novartis Nutrition Corp., Minneapolis, MN) in a quantity based on individual caloric requirement. On day 15 (prior to solid food), subjects returned for a follow-up breath test and those with an abnormal LBT were continued on the diet for an additional 7 days. The ability of an elemental diet to normalise the LBT was determined for days 15 and 21. A chart review was then conducted to evaluate any clinical benefit 1 month later.

Of the 93 subjects available for analysis, 74 (80%) had a normal LBT on day 15 of the elemental diet. When those who continued to day 21 were included, five additional patients normalised the breath test (85%). On chart review, subjects who successfully normalised their breath test had a 66.4 +/- 36.1% improvement in bowel symptoms, compared to 11.9 +/- 22.0% in those who failed to normalize (P < 0.001). An elemental diet is highly effective in normalising an abnormal LBT in IBS subjects, with a concomitant improvement in clinical symptoms.

Rheumatoid arthritis

Haugen MA, 199438

To evaluate the extent of food allergy/intolerance in rheumatoid arthritis, an elemental (hypoallergenic) diet was studied in a controlled, double-blind pilot study. Ten patients were allocated to an experimental group and 7 to a control group. The patients in the experimental group received an elemental diet for 3 weeks, whereas the patients in the control group received a control soup consisting of milk, meat, fish, shellfish, orange, pineapples, tomatoes, peas and flour of wheat and corn. During the 4th week of the study the patients in both groups resumed their regular diet.

A significant improvement was found in the number of tender joints (p = 0.04) in the experimental group, whereas improvement was found in the erythrocyte sedimentation rate (ESR) (p = 0.03) and in the thrombocyte count (p = 0.02) in the control group. Three patients in the elemental diet group and 2 patients in the control group improved in all of the measured disease variables during the dietary treatment period. There was no significant difference in disease activity variables between the two groups. These results suggest that some RA patients may respond to the elimination of offending food items. However, the results do not encourage treatment with an elemental diet in unselected RA patients.

Eczema

Devlin J, 199121

A total of 37 children with refractory wide-spread atopic eczema were treated with an antigen avoidance regimen comprising hospitalisation, exclusive feeding with an elemental formula for a median duration of 30 days, and measures to reduce exposure to pet and dust mite antigens at home. After the initial period of food exclusion, food challenges were performed at intervals of seven days, and the patients followed up for at least 12 months.

Improvement in the eczema was seen in 27/37 (73%) patients, by discharge from hospital their disease severity score had fallen to a median of 27% of the pretreatment figure, and only 3/27 required topical corticosteroids.

Dermatitis herpetiformis

Kadunce DP, 199122

At entry eight patients with dermatitis herpetiformis, who were consuming unrestricted diets, were stabilised on their suppressive medications at dosage levels that allowed individual lesions to erupt. Six patients were then given an elemental diet plus 30 of gluten for 2 weeks, followed by the elemental diet alone for 2 weeks. Conversely, two patients received an elemental diet alone for 2 weeks followed by an elemental diet plus gluten during the final 2 weeks. Small bowel biopsies, skin biopsies, and clinical assessments were done at 0, 2, and 4 weeks.

Suppressive medication dose requirement decreased over the 4 weeks by a mean of 66%. Six of eight subjects significantly improved clinically during the gluten-challenge phase of the elemental diet and all were improved at the end of the study. The amount of IgA in perilesional skin did not change significantly, but the amount of C3 increased in five of seven evaluable subjects after gluten challenge. Circulating anti-gluten and anti-endomysial antibodies were not significantly affected by the diets. All subjects completing evaluable small bowel biopsies (seven of seven) demonstrated worsening of their villus architecture (by scanning electron microscopy and intraepithelial lymphocyte counts) during gluten challenge and improvement (six of six subjects) after 2 weeks of elemental dietary intake. We conclude that 1) there is a significant improvement in clinical disease activity on an elemental diet, independent of gluten administration, 2) small bowel morphology improves rapidly on an elemental diet, and 3) complement deposition but neither IgA deposition nor circulating antibody levels correlate with gluten intake. It seems likely that dietary factors other than gluten are important in the pathogenesis of the skin lesions in dermatitis herpetiformis.

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3. Elemental Diet Protocols

As with any dietary supplement or medical food, administration and dosing are important components in achieving desired outcomes. Elemental diets (EDs) are no different and therefore understanding protocols can help the heath care practitioner achieve treatment objectives. An important factor in the administration and selection of an ED protocol is the health care practitioner’s assessment and purpose for utilising it. These considerations will be important in calculating the proper protocol for said patient.

The most clinically studied of the EDs is the full elemental diet (full ED). This type was first used in patients with limited or impaired capacity to digest, absorb and/or metabolise foods. As mentioned above, an exclusive ED is implemented in inflammatory bowel disease (IBD) and those conditions which go hand in hand with IBD such as small intestinal bacterial overgrowth (SIBO) and even irritable bowel syndrome (IBS). Continued research into the microbiome and the relationship between gut health and systemic health, including the brain-gut connection, has also led to the development and use of shorter elemental diets, which may help jump-start gut healing.

In clinical practice, once the ED has produced the required effects, a half elemental diet (half ED) can be applied. A half ED defines a diet where half of the caloric human physiological requirements are met with the ED formula and the other half through whole, hypoallergenic foods. Clinical studies have shown that patients have overall better long-term effects when they employ the half ED immediately following a full elemental diet (full ED) in the management of conditions such as CD. 31,32

Protocols:

Part A: Calculating nutritional requirements

1. First calculate the patient’s basal metabolic rate (BMR):

a. Women: BMR = 655 + (4.35 x weight in pounds) + (4.7 x height in inches) - (4.7 x age in years).

OR

b. Women: BMR = 655 + (9.56 × weight in kg) + (1.85 × height in cm) – (4.67 × age in years).

c. Men: BMR = 66 + (6.23 x weight in pounds) + (12.7 x height in inches) - (6.8 x age in years).

OR

d. Men: BMR = 66 + (13.75 × weight in kg) + (5 × height in cm) – (6.8 × age in years).41-43

2. Final calculation with the Harris-Benedict equation: This formula uses the calculated BMR and then applies an activity factor to determine the patient’s actual total daily energy expenditure in calories. The more active the patients is, the more calories they will use.

Harris-Benedict factors are the following:

a. Little to no exercise: BMR x 1.2 = total daily calories.

b, Light exercise/sports 1-3 days/week: BMR x 1.375 = total daily calories.

c. Moderate (moderate exercise/sports 3-5 days/week): BMR x 1.55 = total daily calories.

d. Very active (hard exercise/sports 6-7 days/week): BMR x 1.725 = total daily calories.

e. Extra active (very hard exercise/sports): BMR x 1.9 = total daily calories.41-43

PART B: Different forms of the elemental diet

1. Full elemental diet: The patient consumes 100% of their caloric requirements using the elemental diet (ED). This becomes the patient’s sole source of nutrition for the designated time period, which normally spans 14 days (as evidenced by clinical trials).1-11

Application: Crohn’s disease (CD), small intestinal bacterial overgrowth (SIBO) and irritable bowel syndrome (IBS).3,10

Dosage: To accurately calculate the patient’s total caloric needs, the health care practitioner should determine their basal metabolic rate (BMR) and then use the Harris-Benedict equation above to calculate their total caloric requirements (approximately 1800 calories per day). The patient should be advised to take the calories in divided doses during the day: approximately 200-300 calorie servings every 2 to 3 hours over a 30 minute period until the caloric requirements are met.

Duration: Two weeks has been clinically validated. This time period can be extended at the sole discretion of the health care practitioner, if necessary.

2. Half elemental diet: The patient consumes 50% of their daily caloric needs from the ED and the other 50% from a whole food diet. Half elemental diets (half EDs), are found in the scientific literature to help with maintaining remission of CD.33 They can also be used when compliance becomes difficult for patients on full elemental diets for SIBO and IBS. Half elemental diets can also be used as starting and exiting conduits to full elemental diets (full EDs), easing the patient experience and possibly improving compliance.32

Application: Maintaining remission of CD after completion of the full ED, used as conduits to full EDs and in place of full EDs for patients having difficulty with compliance. This will be at the discretion of the health care practitioner.32

Dosage: The dose supplied by the half ED is 50% of the daily total calories divided into 200-300 calorie servings, consumed every 2 hours (use either in the first or second half of the day). In whatever part of the day the half ED is not used, the patient consumes a whole food diet as per usual.

To accurately calculate the patient’s total needs the physician should determine their BMR and then use the Harris-Benedict equation (see above) to calculate total caloric requirements (divide this by half to give you the calories needed from the half ED, which should be approximately 900 calories per day).32

Duration: There are no published reports specifically demonstrating the optimal duration of a half ED, however, 4-6 weeks can be a good starting point. The duration would be calculated at the discretion of the health care practitioner, taking into account various patient symptomatology and other markers deemed important.

3. Short elemental diet: This can be used to give the gastrointestinal tract a “rest“ by avoiding all the complex processes involved in digestion, including allergen and by-product exposure created through digestive and absorption processes. This can be useful in helping support gut mucosal healing processes. Due to the short duration, the compliance is usually very good and may be used as a “bridge” to introduce the full ED.

Dosage: In a short elemental diet (short ED) dosing can follow either the full ED or half ED directives and calculations can be made accordingly.

Duration: There are no published data regarding the duration of a short ED, however 1-3 days is generally the accepted time frame amongst health care practitioners.

4. Intermittent elemental diet: Although intermittent elemental diets (intermittent EDs) have no clinical research, some health care practitioners believe that benefits can be gained from giving the gastrointestinal tract a period of “rest” during parts of the day. In particular, the possible restoration of the migrating motor complex, and in turn overall gastrointestinal health, by acting as a type of fast without compromising nutritional status.

Dosage: Intermittent EDs entail consuming 300 calories over a 15 minute period.

Duration: There are no published studies on this type of ED, but much like intermittent fasting, it can go on for several months. It is important to always be under the guidance of a health care practitioner during this time.

Part C: Patient monitoring

Elemental diets are completed under the supervision of a health care practitioner, where a number of markers are monitored:

1. Compliance: Physicians need to ensure that their patients report the correct number of calories being consumed per day, according to directives.44

2. Weight: Monitoring weight is also important as there will be some weight reduction in the first week of treatment on the full elemental diet. Monitoring this marker also ensures that caloric consumption needs are being met during the diet.44

3. Symptoms: Monitor symptoms throughout the program: cramping and diarrhoea due to osmolality, constipation and nausea. All of these symptoms should be reported by the patient to their physician as the diet may need to be adjusted as a result.44

4. The Lactulose Breath Test (LBT): This helps diagnose SIBO, a condition that often goes hand in hand with irritable bowel syndrome and irritable bowel disease (IBS and IBD). Lactulose is a large sugar which is not digested by the body and thus has the ability to travel through the entire small intestine. During the test, patients are given a bolus of lactulose and then they collect breath over a period of time. Bacteria will take the lactulose and produce gases that include hydrogen and methane, depending on the type and quantity of bacteria. If certain percentages of gases are found in the breath, a diagnosis of SIBO is given.29

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4. References

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