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©The Author(s) 2016.
World J Gastrointest Pharmacol Ther. May 6, 2016; 7(2): 306-319
Published online May 6, 2016. doi: 10.4292/wjgpt.v7.i2.306
Published online May 6, 2016. doi: 10.4292/wjgpt.v7.i2.306
Table 1 Selected studies of semi-elemental whey hydrolyzed protein diets and Crohn’s disease and other gastrointestinal complications
| Ref. | Study population | Design | Feeding mode (comparison) | No. patients (comparison) | Feeding duration | Relevant results1 |
| Polk et al[11] | Children, tanner stage I-II, mean age 13.6 | Prospective cross-over | Isotonic hydrolyzed whey formula administered via nocturnal nasogastric infusion (patients served as their controls based on observations at least a year before the study) | 6 (6, served as own controls) | Intermittent diet program for 1 yr | Height increased 2.6 ± 0.8 to 9.3 ± 0.9 cm/yr (P < 0.0001) Weight increased 3.0 ± 1.2 to 6.63 ± 1.2 kg/yr (P < 0.02) Somatomedin C increase 0.7 ± 0.1 to 1.8 ± 0.3 UL (P < 0.0001) Albumin increase 3.4 ± 0.2 to 4.0 ± 0.1 g/dL (P < 0.0003) CDAI increase 64 ± 3.4 to 80.1 ± 2.2 (P < 0.01) (disease activity inversely correlates with numerical score) |
| Hussey et al[13] | Children with active CD, mean age 11.4 | Prospective, NR, open-label pilot | Peptamen with Prebio via nasogastric tubes | 10 - single group | 6 wk | Height increased 143.8 ± 13 to 144.5 ± 13.1 cm (P < 0.01) Weight increases 31.9 ± 7.2 to 36.5 ± 8.1 kg (P < 0.0001) PCDAI decrease 40 ± 13 to 5 ± 6 (P < 0.0001) (lower score corresponds to lower disease activity) Albumin increase 3.1 ± 0.4 to 3.8 ± 0.4 g/dL (P < 0.01) PEDIBDQ increase 198 ± 31 to 243 ± 34 (P < 0.01) (higher score indicating better quality of life) |
| Royall et al[14] | Adults with moderate to severely active CD | RCT | Peptamen administered via a nasoduodenal feeding tube (Vivonex-TEN, amino acid based formula) | 21 (19) | 3 wk | Remission rates after 3 wk: 75% in the peptide group, 84% in the amino acid group Remission rates after 1 yr: 40% in the peptide group, 31% in the amino acid group Weight increased 2.0 ± 0.5 kg in the peptide group and 1.7 ± 0.3 kg in the amino acid group (P < 0.0005 within group differences after 3 wk) Total phospholipids (mg/mL) concentration increase in the peptide group (1.37 ± 0.1 to 1.71 ± 0.15) (P < 0.025) (no difference in amino acid group) |
| Mansfield et al[15] | Adults with active CD | RCT | Pepti-2000 LF Liquid received through nasogastric tube (Elemental 028) | 22 (22) | 4 wk | Remission rates after 4 wk: 36% in the Pepti-2000 group and 36% in the E028 group Mean percent ideal body weight: Pepti-2000 group increased from 92 ± 4 to 95 ± 4 and E028 group remained the same at 83 ± 5 |
| Middleton et al[16] | Adults with active CD | RCT | Pepdite 2+ given orally or through nasogastric tube if necessary (Elemental 028/Elemental 028 + LCT/Elemental 028 + MCT) | 18 (17/22/19) | 3 wk | Remission rates after 3 wk: 87% in Pepdite 2+ group, 92% in the E028 group, 55% in the E028 LCT group, and 92% in the E028 MCT group Mean CRP: Decreased significantly in E028 group and E028 MCT group, but non-significantly decreased in Pepdite 2+ group and E028 LCT group (values not provided) |
| Zoli et al[17] | Adults with moderately active CD | RCT | Peptamen received orally (0.5 mg/kg per day prednisolone) | 10 (10) | 2 wk | Peptide group: CD activity score (CDAS): 5.6 ± 0.8 to 2 ± 1.4 (P < 0.01) ESR: 21.4 ± 6 to 16.7 ± 6.7 (P < 0.05) Permeability index: 4.9 ± 5.3 to 2.1 ± 2 (P < 0.01) BMI: 18.5 ± 3 to 19.2 ± 3.1 (P < 0.02) Prealbumin: 22.2 ± 8 to 23.5 ± 7.8 (P < 0.01) Retinol binding protein: 3.7 ± 0.7 to 4 ± 0.8 (P < 0.02) In vivo cell-mediated immunity (Multitest IMC): 4.2 ± 2.1 to 5.9 ± 2.3 (P < 0.01) (in the corticosteroid group, there were significant findings for improvement of simple CD activity index and fat free mass) |
| Pereira et al[18] | Adults with mildly active CD and healthy laboratory staff | Follow-up study (secondary study) | Peptamen received orally (0.5 mg/kg per day prednisolone) | 13 CD patients (17 healthy controls) | 2 wk | No significant differences between groups in clinical response to treatment, markers of disease activity, or plasma phospholipid classes (data not reported) |
| Malchow et al[19] | Adults with active CD | RCT | Survimed given orally (12-48 mg/d 6-methyl prednisolone and 3 g/d sulfasalazine) | 51 (44) | 6 wk | Percent underweight after 3 wk: 15.1% in Survimed group and 13.4% in steroid group Crohn’s disease activity index after 3 wk: 87.2 in Survimed group and 88.8 in steroid group Number of soft stools per week after 3 wk: 43.2 in Survimed group and 60.0 in steroid group |
| Lochs et al[20] | Adults with acute active CD | RCT | Peptisorb received through nasogastric tube (12-48 mg/d 6-methyl prednisolone and 3 g/d sulfasalazine) | 55 (52) | 6 wk | Remission rates after 6 wk: 52.7% in the Peptisorb group and 78.8% in the steroid group (P < 0.01) Body weight: increased in Peptisorb group from 55.6 ± 1.8 kg to 58.9 ± 1.6 kg, and increased in steroid group from 53.5 ± 1.3 kg to 56.8 ± 1.2 kg after treatment Number of soft stools per week: Decreased in Peptisorb group from 31.9 ± 4.3 to 9.7 ± 1.8 and decreased in steroid group from 37.1 ± 2.9 to 9.4 ± 1.5 after treatment |
| Lindor et al[21] | Adults with active CD | RCT | Vital HN received orally or through nasogastric tube if necessary (0.75 mg/kg per day prednisone) | 9 (10) | 1 mo | Decrease in Crohn’s disease activity index of 50 points or more after 1 mo: 33% in vital HN group and 70% in steroid group |
| Sakurai et al[22] | Adults with active CD | RCT | Twinline received through nasogastric tube (Elental) | 18 (18) | 6 wk | Remission rates after 6 wk: 72% (47%-90%) in Twinline group and 67% (41%-87%) in the Elental group Crohn’s disease activity index after 6 wk: 82 in Twinline group and 102 in Elental group |
| Khoshoo et al[5] | Children with gastrointestinal dysmotility (n = 9), CD (n = 3), mild short bowel syndrome (n = 2) | Randomized, double-blind, cross-over clinical study | Peptamen Junior and Peptamen Junior with fiber and prebiotics | 14 | 1 formula for 2 wk, 5 d washout, 2nd formula for 2 wk | Flatulence/gas among 9 children with a neurological disorder: Significantly less for the fiber formula (P < 0.05) Frequency of bowel movements: No difference between groups (P > 0.05) Stool frequency in the CD group: Higher with the fiber formula but no change in consistency (data not reported) |
| Parekh et al[23] | Patients undergoing intestinal rehab with varying diseases [radiation enteritis (n = 5), ulcerative colitis (n = 1), bowel volvulus (n = 1), mesenteric ischemia (n = 1)] | Cross-over study | Semi-elemental/polymeric diet with a switch to an isocaloric, isotonic, semi-elemental formula with prebiotics | 2 (6) | 4.9 mo after an initiation of 60 d post-abdominal resection; second diet for a mean of 2.9 mo | Weight change: Mean loss of 5.1% in the semi-elemental/polymeric group, mean gain of 5.7% in the isocaloric, isotonic, semi-elemental formula with prebiotics group |
| Hamaoui et al[10] | Patients undergoing major abdominal surgery | Randomized prospective study | Reabilan HN, small peptide based formula via jejunostomy (equicaloric isonitrogenous total PN) | 11 (8) | Primary analyses within 1 wk of enrollment | Mean daily stool output: 93.1 ± 68.5 g/d in the Reabilan group, 22.2 ± 35.3 g/d in the PN group (P < 0.05) No significant differences between groups for serum albumin, prealbumin, or plasma transferrin Average daily cost of supplies: $44.36 ± 8.50 for the Reabilan group, $102.10 ± 11.77 for the PN group (P < 0.001); non-nutrient supplies accounted for 13% of the cost in the Reabilan group vs 43% in the PN group |
| Kowalski et al[25] | Patients who received a post ITx | Retrospective case review | Peptide product (amino acid product) | 34 (15) | Primary analyses within 6 mo | Time to full feedings post ITx from baseline to 1 to 2 yr: Peptide group z-scores: -2.71, -2.36, -2.32 (monotonic trend) Amino acid group z-scores: -2.46, -2.29, -2.35 Time to reaching full feeds (among those receiving rATG therapy): 3 mo in the peptide group, 5 mo in the amino acid group (P > 0.05) |
| Murray et al[24] | Children with short bowel syndrome | Randomized cross-over study | Peptamen (Vivonex TEN, high carbohydrate) | 6 | Two, 7 d periods | Mean ostomy output: 39 cc/kg per day in the Peptamen group, 49 cc/kg per day in the Vivonex TEN group Fat excretion: Identical in both groups (P = 0.9) Trace element analysis: Greater excretion of copper (P = 0.0002) and sulfur (P = 0.02) in the Vivonex TEN group |
Table 2 Selected studies of semi-elemental whey hydrolyzed protein diets and pancreatitis
| Ref. | Study population | Design | Feeding mode (comparison) | No. patients (comparison) | Feeding duration | Relevant results1 |
| Tiengou et al[27] | Consecutive patients with acute pancreatitis admitted to a gastroenterology and nutrition department | Randomized prospective pilot study | Peptamen (polymeric diet group, sondalis-Iso) | 15 (15) | 1 wk | Weight (kg): -1.3 ± 1.1 in the peptide group, -2.4 ± 0 in the polymeric group (P < 0.01) Total hospital stay (d): 23 ± 2 in the peptide group, 27 ± 1 in the polymeric group (P = 0.006) Infection: 1/15 in the peptide group, 3/15 in the polymeric group (NS) |
| Louie et al[9] | Consecutive patients with acute pancreatitis in an academic, multi-institutional, tertiary care system | RCT | Peptamen administered via nasojejunal feeding tubes (parenteral nutrition, intralipid administered via long-term vascular catheters) | 10 (18) | Primary analyses within 1 wk of enrollment | C-reactive protein: Reduced 50% at a median of 5 d faster for the peptide group (6 d) vs the PN group (11 d) (P = 0.09) Serum cholecystokinin: 56 pmol/L to 55 pmol/L (P = 0.2) in the peptide group, 42 pmol/L to 32 pmol/L in the PN group (P = 0.5) Mortality: 0 deaths in the peptide group, 3 deaths in the PN group (attributable to complications of pancreatitis) Economic cost: Peptide group = $1375, PN group = $2608 (P = 0.08); when 1 NJ tube used: Peptide group = $1086, PN group = $2608 (P = 0.03) |
| McClave et al[28] | Patients with acute pancreatitis or an acute flare of chronic pancreatitis | RCT | Peptamen infused through a nasojejunal tube (total parenteral nutrition infused through a central or peripheral line) | 16 (16) (30 patients over 32 admissions) | Primary analyses within 1 wk of enrollment | Length of ICU stay (d): 1.3 ± 0.9 in the peptide group, 2.8 ± 1.3 in the PN group (NS) Length of hospital stay (d): 9.7 ± 1.3 in the peptide group, 11.9 ± 2.6 in the PN group (NS) Economic cost: $761 ± 50.3 in the peptide group, $3294 ± 551.9 in the PN group (P < 0.005) |
| Kalfarentzos et al[32] | Patients with acute pancreatitis admitted to surgery unit | Randomized prospective trial | Reabilan HN administered via nasoenteric feeding tube (parenteral nutrition as all-in-one continuous subclavian polyurethane catheter infusion) | 18 (20) | Mean: 34.8 d (mean: 32.8 d ) | Septic complications: 27.8% in peptide group, 50% in PN group (P < 0.01) Any complications: 44.4% in peptide group, 75% in PN group (P < 0.05) Mean stay in ICU: 11 d in peptide group, 12 d in PN group (significance not provided) |
| Oláh et al[29] | Patients admitted to surgical ward with a diagnosis of acute pancreatitis | Two-phase controlled prospective trial | Survimed administered via NJ tube (parenteral nutrition as an all-in-one venous admixture) | 41 (48) | 5-9 d (5-16 d ) | Necrosis: 29% in peptide group, 33% in PN group (NS) Septic complications: 12% in peptide group, 27% in PN group (P = 0.08) Surgery: 12% in peptide group, 23% in PN group (NS) Severe pancreatitis: 17% in peptide group, 21% in PN group (NS) Death: 4.9% in peptide group, 8.3% in PN group (NS) |
| Petrov et al[30] | Patients with severe acute pancreatitis | RCT | Peptamen administered through NJ tube (parenteral nutrition administered through central venous catheter) | 35 (34) | Assessment on day of feed commence-ment, fourth and seventh days | Pancreatic infection: 20% in peptide group, 47% in PN group (P = 0.022) Noninfectious complications: 42.9% in peptide group, 17.6% in PN group (P = 0.036) Serum CRP concentration: 195 (164-216) mg/L on admission to 94 (56-117) mg/L on day 7 in peptide group, 210 (177-246) mg/L on admission to 93 (60-134) on day 7 in PN group (NS) Mortality: 6% in peptide group, 35% in PN group (P = 0.003) |
| Kumar et al[4] | Consecutive patients with severe acute pancreatitis | Randomized pilot study | Peptamen administered through enteral tubes in both groups; patients were randomly allocated to NG or NJ feeding | 15 NG, 16 NJ | 1 wk | Hospital stay (d): 29.93 ± 25.54 in NJ group, 24.06 ± 14.35 in NG group (P = 0.437) Mortality: 4/14 in NJ group, 5/16 in NG group Recurrence of pain: 1/14 in NJ group, 1/16 in NG group Serum albumin: No significant differences Anthropometric measurements: No significant differences in BMI, mid upper arm circumference, and triceps skin fold thickness) |
| Shea et al[6] | Patients with chronic pancreatitis; healthy control subjects | Follow-up study | Consumption of 3 cans of Peptamen (the same patients completed a daily pain assessment form for 2 wk prior to initiation of enteral formulation) | 8, EN evaluated within this group; 6 healthy control subjects receiving EN also evaluated | 2 wk baseline period, 10 wk formula period; healthy controls evaluated on a daily basis | Healthy controls: Postprandial plasma CCK: Mean basal CCK levels = 0.46 ± 0.29 pmol/L High fat solid meal = 10.75 ± 0.45 pmol/L Liquid meal full-length triglycerides and intact proteins = 7.9 ± 1.25 pmol/L Liquid meal Peptamen = 1.43 ± 0.72 pmol/L (P < 0.05 compared with other meals) |
| Freedman[31] | Healthy volunteers | Prospective cross-over | Peptamen, one can over 2 min following an overnight fast (1/4lb hamburger; one can of Ensure) | 6 (6, served as own controls) | Assessment immediately after consumption | Chronic pancreatitis patients: Median improvement in pain scores from baseline = 68.5% (P = 0.011) 5 of 8 patients had statistically significant decreases in pain scores Mean basal CCK levels = 0.46 ± 0.29 pmol/L Hamburger = 10.75 ± 0.45 pmol/L Ensure = 7.9 ± 1.25 pmol/L Peptamen = 1.43 ± 0.72 pmol/L (P < 0.0001 compared with other meals) |
Table 3 Selected studies of semi-elemental whey hydrolyzed protein diets and stroke
| Ref. | Study population | Design | Feeding mode (comparison) | No. patients (comparison) | Feeding duration | Relevant results1 |
| de Aguilar- Nascimento et al[40] | Elderly patients with acute ischemic stroke | RCT | NG feeding with Peptamen (Hiper-diet Energy Plus, standard formula containing hydrolyzed casein) | 10 (15) | 5 d | Mortality: 3/10 in Peptamen group, 4/15 in the casein group (P = 1.0) ICU length of stay: 16 ± 8 d in the Peptamen group, 16 ± 5 d in the casein group (P = 0.97) IL-6 (pg/dL): Peptamen group: 62.7 ± 56.2 to 20.6 ± 10.3 Casein group: 64.3 ± 40.3 to 42.0 ± 26.7 (P = 0.03 between group difference) Glutathione (U/G Hb): Peptamen group: 32.2 ± 2.1 to 39.9 ± 4.8 Casein group: 30.0 ± 5.0 to 26.2 ± 6.7 (P = 0.03 between group difference) Glucose (mg/dL) Peptamen group: 132 ± 19 to 139 ± 18 Casein group: 148 ± 20 to 214 ± 43 (P = 0.17 between group difference) |
| Miyazaki et al[41] | Severe acute stroke patients requiring tube feeding | Retrospective follow-up study | Peptamen through an enteral feeding tube (mein, normal protein enteral formula) | 37 (35) | 1 wk | In hospital mortality: 2.7% in the Peptamen group, 22.9% in the Mein group (P < 0.05) Blood urea nitrogen (BUN, median): 35 mg/dL in the Peptamen group, 23 mg/dL in the Mein group (P < 0.05) |
Table 4 Suggestions for future semi-elemental whey hydrolyzed protein diet studies
| Level of study process | Suggestions for future semi-elemental WHP diet studies |
| Study development and initiation | Clearly defined study population with reported response rates and loss-to-follow-up data |
| Study development and initiation | Identification and inclusion of a study population with sufficient statistical power to determine a difference between the formulas under study. The estimated number of subjects based on power calculations should be included in the methods section |
| Study development and initiation | Stated goals and objectives of the analytical research. Given the multitude of possible outcomes, researchers should strive to clearly state the objective endpoints of the analysis |
| Analytical comparisons | Clearly define the dietary formulas and product names under study to facilitate a more complete and accurate summary of the findings across studies |
| Results | Present results with levels of variance such that future systematic reviews and quantitative assessments can combine data across studies Present results by intake level and duration of follow-up such that future assessments can evaluate quantitatively these important factors when weighing the evidence |
| Discussion | Identify important study design, analytical, or other research limitations and challenges so subsequent researchers can endeavor to address these challenges |
- Citation: Alexander DD, Bylsma LC, Elkayam L, Nguyen DL. Nutritional and health benefits of semi-elemental diets: A comprehensive summary of the literature. World J Gastrointest Pharmacol Ther 2016; 7(2): 306-319
- URL: https://www.wjgnet.com/2150-5349/full/v7/i2/306.htm
- DOI: https://dx.doi.org/10.4292/wjgpt.v7.i2.306