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Background: Hydrolysed rice formula (HRF) is tolerated by >90% of children with cow’s milk protein allergy (CMPA). However, concerns have been raised about potential suboptimal growth in infants fed HRF compared to those fed an extensively hydrolysed milk protein formula (eHF). Aims: To compare growth, safety and tolerance acquisition in infants with CMPA when fed HRF versus eHF. Methods: A multicentre prospective, randomised, double-blind, placebo-controlled food challenge trial was conducted with infants with CMPA. The infants received either HRF or eHF over a 12-month follow-up period. The primary outcome measure was the change from baseline over the study period in weight-for-length expressed as a Z-score. The secondary outcomes were other anthropometric measurements, tolerability and adverse events (AEs). Results: In total, 105 children were enrolled. The weight-for-length measurements were −0.01 (HRF) and −0.29 (eHF) at baseline and 0.29 and 0.05, respectively, at the last visit, with no significant between-group difference (p = 0.28; mixed-effects model). The Z-scores for other anthropometric variables indicated normal growth, with no significant between-group differences. In total, 29 potentially product-related AEs were reported (12 in the HRF group and 17 in the eHF group). A trend was observed toward a faster acquisition of tolerance in the HRF group (median age: 20.4 months) compared to the eHF group (16.3 months), but this was not statistically significant (p = 0.18). Conclusions: HRF demonstrated appropriate growth, acquisition of tolerance and a good safety profile in infants with CMPA, with no significant differences versus eHF. HRF could be considered as an appropriate option in the management of CMPA.

Milk proteins have been hypothesized to protect against type 2 diabetes (T2DM) by beneficially modulating glycemic response, predominantly in the postprandial status. This potential is, amongst others, attributed to the high content of whey proteins, which are commonly a product of cheese production. However, native whey has received substantial attention due to its higher leucine content, and its postprandial glycemic effect has not been assessed thus far in prediabetes. In the present study, the impact of a milk protein hydrolysate of native whey origin with alpha-glucosidase inhibiting properties was determined in prediabetics in a randomized, cross-over trial. Subjects received a single dose of placebo or low- or high-dosed milk protein hydrolysate prior to a challenge meal high in carbohydrates. Concentration–time curves of glucose and insulin were assessed. Incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by low-dosed milk peptides compared to placebo (p = 0.0472), and a minor insulinotropic effect was seen. A longer intervention period with the low-dosed product did not strengthen glucose response but significantly reduced HbA1c values (p = 0.0244). In conclusion, the current milk protein hydrolysate of native whey origin has the potential to modulate postprandial hyperglycemia and hence may contribute in reducing the future risk of developing T2DM.

Food allergy is a major public health problem, for which there is no effective treatment. We examined the immunological changes that occurred in a group of children with significant cow’s milk allergy undergoing a novel and rapid high-dose oral desensitization protocol enabled by treatment with omalizumab (anti-immunoglobulin (Ig)E monoclonal antibodies). Within a week of treatment, the CD4+ T-cell response to milk was nearly eliminated, suggesting anergy in, or deletion of, milk-specific CD4+ T cells. Over the following 3 months while the subjects remained on high doses of daily oral milk, the CD4+ T-cell response returned, characterized by a shift from interleukin-4 to interferon-γ production. Desensitization was also associated with reduction in milk-specific IgE and a 15-fold increase in milk-specific IgG4. These studies suggest that high-dose oral allergen desensitization may be associated with deletion of allergen-specific T cells, without the apparent development of allergen-specific Foxp3+ regulatory T cells.

Objectives Previous laboratory studies have identified two dairy fractions, glycomacropeptide (GMP) and G600 milk fat extract (G600), with anti-inflammatory effects in models of acute gout. The aim of this proof-of-concept clinical trial was to test the hypothesis that daily intake of skim milk powder (SMP) enriched with GMP and G600 can prevent gout flares. Methods This was a 3-month randomised double-blind controlled trial of milk products for prevention of gout flares. One hundred and twenty patients with recurrent gout flares were randomised to one of three arms: lactose powder control, SMP control and SMP enriched with GMP and G600 (SMP/GMP/G600). The primary end point was change in the frequency of gout flares using a daily flare diary measured monthly for 3 months. Results The frequency of gout flares reduced in all three groups over the 3-month study period compared with baseline. Over the 3-month study period there was a significantly greater reduction in gout flares in the SMP/GMP/G600 group (analysis of covariance pgroup=0.031, Tukey post hoc test compared with lactose control, p=0.044). Following treatment with SMP/GMP/G600 over the 3-month period, greater improvements were also observed in pain and fractional excretion of uric acid, with trends to greater improvement in tender joint count. Similar adverse event rates and discontinuation rates were observed between the three groups. Conclusions This is the first reported controlled trial of dietary intervention in patients with gout, and suggests that SMP enriched with GMP and G600 may reduce the frequency of gout flares.

Background: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2′-FL in an intended use population of infants. Methods: A non-randomized, single-group, multicenter study was conducted. Infants (0–60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study. Results: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078). Conclusions: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population.

Objectives:To determine tolerance rates to cow’s milk and soy and to suggest guidelines for follow-up oral food challenges (FU-OFCs) in infantile food protein-induced enterocolitis syndrome (FPIES).Methods:The authors analysed the data of 23 patients with infantile FPIES who underwent two or more FU-OFCs and were followed up until over 2 years of age. The first FU-OFCs were performed at 6 months of age, and patients were randomly allocated to cow’s milk (n = 11) or soy (n = 12) challenge starting groups. Second and third FU-OFCs were performed at 2-month intervals in a crossed and switched-over manner.Results:Tolerance rates to cow’s milk and soy were 27.3% and 75.0% at 6 months of age, 41.7% and 90.9% at 8 months and 63.6% and 91.7% at 10 months, respectively. Patients outgrew cow’s milk and soy intolerance at age 20 and 14 months.Conclusions:In infantile FPIES, the first FU-OFC should be performed with soy at 6–8 months of age and cow’s milk FU-OFC should be conducted at over 12 months of age. Infants with FPIES were observed to outgrow food sensitivities during the first 2 years of life.

Background Dairy proteins, in particular the whey fraction, exert insulinogenic properties and facilitate glycemic regulation through a mechanism involving elevation of certain plasma amino acids, and stimulation of incretins. Human milk is rich in whey protein and has not been investigated in this respect. Method Nine healthy volunteers were served test meals consisting of human milk, bovine milk, reconstituted bovine whey- or casein protein in random order. All test meals contributed with 25g intrinsic or added lactose, and a white wheat bread (WWB) meal was used as reference, providing 25g starch. Post-prandial levels in plasma of glucose, insulin, incretins and amino acids were investigated at time intervals for up to 2 h. Results All test meals elicited lower postprandial blood glucose responses, expressed as iAUC 0–120 min compared with the WWB (P < 0.05). The insulin response was increased following all test meals, although only significantly higher after whey. Plasma amino acids were correlated to insulin and incretin secretion (iAUC 0–60 min) (P ≤ 0.05). The lowered glycemia with the test meals (iAUC 0–90 min) was inversely correlated to GLP-1 (iAUC 0–30 min) (P ≤ 0.05). Conclusion This study shows that the glycemic response was significantly lower following all milk/milk protein based test meals, in comparison with WWB. The effect appears to originate from the protein fraction and early phase plasma amino acids and incretins were involved in the insulin secretion . Despite its lower protein content, the human milk was a potent GLP-1 secretagogue and showed insulinogenic properties similar to that seen with reconstituted bovine whey-protein, possibly due to the comparatively high proportion of whey in human milk.

Background Increased intestinal permeability (IP) has been implicated in the etiopathogenesis, disease activity and relapse of Crohn’s disease (CD). Glutamine, the major fuel for the enterocytes, may improve IP. Aim We evaluated the effect of oral glutamine on IP and intestinal morphology in patients with CD. Methods In a randomized controlled trial, consecutive patients with CD in remission phase with an abnormal IP were randomized to a glutamine group (GG) or active control group (ACG) and were given oral glutamine or whey protein, respectively, as 0.5 g/kg ideal body weight/day for 2 months. IP was assessed by the lactulose mannitol excretion ratio (LMR) in urine, and morphometry was performed by computerized image analysis system. Results Patients (age 34.5 ± 10.5 years; 20 males) were assigned to the GG ( n  = 15) or ACG ( n  = 15). Fourteen patients in each group completed the trial. The LMR [median (range)] in GG and ACG at 2 months was 0.029 (0.006–0.090) and 0.033 (0.009–0.077), respectively, with P  = 0.6133. IP normalized in 8 (57.1%) patients in each group ( P  = 1.000). The villous crypt ratio (VCR) [mean (SD)] in GG and ACG at 2 months was 2.68 (1.02) and 2.49 (0.67), respectively, ( P  = 0.347). At the end of 2 months LMR improved significantly in GG from 0.071 (0.041–0.254) to 0.029 (0.006–0.090) ( P  = 0.0012) and in ACG from 0.067 (0.040–0.136) to 0.033 (0.009–0.077) ( P  = 0.0063). VCR improved in the GG from 2.33 (0.77) to 2.68 (1.02) ( P  = 0.001), and in ACG from 2.26 (0.57) to 2.49 (0.67) ( P  = 0.009). Conclusions Intestinal permeability and morphology improved significantly in both glutamine and ACG.

The diurnal rhythm of bone remodeling suggests nocturnal dietary intervention to be most effective. This study investigated the effect of bedtime ingestion of a calcium-fortified, milk-derived protein matrix (MBPM) or maltodextrin (CON) on acute (0–4 h) blood and 24-h urinary change in biomarkers of bone remodeling in postmenopausal women with osteopenia. In CON, participants received 804 ± 52 mg calcium, 8.2 ± 3.2 µg vitamin D and 1.3 ± 0.2 g/kg BM protein per day. MBPM increased calcium intake to 1679 ± 196 mg, vitamin D to 9.2 ± 3.1 µg and protein to 1.6 ± 0.2 g/kg BM. Serum C-terminal cross-linked telopeptide of type I collagen (CTX) and procollagen type 1 amino-terminal propeptide (P1NP), and urinary N-telopeptide cross-links of type I collagen (NTX), pyridinoline (PYD) and deoxypyridinoline (DPD) was measured. Analyzed by AUC and compared to CON, a −32% lower CTX (p = 0.011, d = 0.83) and 24% (p = 0.52, d = 0.2) increase in P1NP was observed for MBPM. Mean total 24 h NTX excreted in MBPM was −10% (p = 0.035) lower than CON. Urinary PYD and DPD were unaffected by treatment. This study demonstrates the acute effects of bedtime ingestion of a calcium-fortified, milk-based protein matrix on bone remodeling.

Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fissures (AFs). We aimed to evaluate (1) the effectiveness of diet in curing AFs and to evaluate (2) the clinical effects of a double-blind placebo-controlled (DBPC) challenge, using cow's milk protein or wheat. One hundred and sixty-one patients with AFs were randomized to receive a \"true-elimination diet\" or a \"sham-elimination diet\" for 8 weeks; both groups also received topical nifedipine and lidocaine. Sixty patients who were cured with the \"true-elimination diet\" underwent DBPC challenge in which cow's milk and wheat were used. At the end of the study, 69% of the \"true-diet group\" and 45% of the \"sham-diet group\" showed complete healing of AFs (P<0.0002). Thirteen of the 60 patients had AF recurrence during the 2-week cow's milk DBPC challenge and 7 patients had AF recurrence on wheat challenge. At the end of the challenge, anal sphincter resting pressure significantly increased in the patients who showed AF reappearance (P<0.0001), compared with the baseline values. The patients who reacted to the challenges had a significantly higher number of eosinophils in the lamina propria and intraepithelial lymphocytes than those who did not react to the challenges. An oligo-antigenic diet combined with medical treatment improved the rate of chronic AF healing. In more than 20% of the patients receiving medical and dietary treatment, AFs recurred on DBPC food challenge.