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Human milk oligosaccharides (HMOs) are the third most abundant solid component in human milk after lactose and lipids. Preclinical research has demonstrated that HMOs and specifically 2′-fucosyllactose (2′-FL) are more than a prebiotic and have multiple functions, including immune, gut, and cognition benefits. Previously, human milk has been the only source for significant levels of HMOs. The most abundant HMO in most mothers’ breast milk is 2′-FL. Recently, 2′-FL has been synthesized and shown to be structurally identical to the 2′-FL found in human milk. 2′-FL HMO is now available in some commercial infant formulas. The purpose of this narrative review was to summarize the clinical experiences of feeding infant formula supplemented with the HMO, 2′-FL. Most of these studies investigated standard intact milk protein-based infant formulas containing 2′-FL, and one evaluated a partially hydrolyzed whey-based formula. Collectively, these clinical experiences demonstrated that 2′-FL being added to infant formula was safe, well-tolerated, and absorbed and excreted with similar efficiency to 2′-FL in human milk. Further, infants that were fed formula with 2′-FL had immune benefits, fewer parent-reported respiratory infections, and improved symptoms of formula intolerance. Ultimately, infant formula with 2′-FL supports immune and gut health and is closer compositionally and functionally to human milk.

Background Impaired growth, accompanied by low lean mass and poor bone mineralization in undernourished children, is linked to adverse short- and long-term health outcomes. Oral nutritional supplements (ONS) promote catch-up growth, but their efficacy in improving lean mass and bone mineralization remains uninvestigated. This study aims to compare the efficacy of long-term ONS with dietary counseling (DC) versus DC alone on growth, body composition, bone mineralization, and health outcomes in children with or at risk of undernutrition. Methods Children ( n  = 330) aged 24–60 months with WHO Growth Standard z-scores of weight-for-age < − 1, height-for-age < − 1, and weight-for-height < 0 were randomized in a multisite controlled trial to receive two servings of a complete and balanced ONS formula with DC, or DC-only, for 240 days. Anthropometric measurements, dietary intake, and parent-reported measures of illness-related and other health outcomes were assessed at baseline and days 30, 120, and 240. Dual X-ray absorptiometry–assessed body composition and bone mineralization, and nutritional blood biomarkers were measured at baseline and day 240. Results ONS supplementation augmented growth in height and weight through day 240, with increasing between-group differences over visits ( P  < 0.01 for treatment-by-visit interaction in height, weight, height-for-age and weight-for-age z-scores). Energy and protein intake levels were 26% and 22% higher, respectively, in the ONS + DC compared to the DC-group at day 240 (both P  < 0.001). The ONS + DC group also had a higher lean mass index of 11.06 (0.05) versus 10.92 (0.05) kg/m2 ( P  = 0.048) and total body less head bone mineral density of 0.407 (0.003) versus 0.399 (0.003) g/cm2 ( P  = 0.03) at day 240, with no differences in fat mass index compared to DC. The ONS + DC group also had better serum vitamin D and K status, fewer sick and missed school days, better parent-reported sleep habits, appetite, energy, and physical activity levels versus DC-group (all P  < 0.05). Conclusion Adding ONS to DC for 8 months improved linear catch-up growth and supported quality growth, as evidenced by greater lean mass and bone mineral accretion. These findings, alongside parent-reported improvements in child health, suggest that improved nutrient intake with ONS improves multiple domains of child health and well-being. Trial registration This clinical trial was registered on ClinicalTrials.gov (registration number: NCT05239208) on 14 February 2022. 4YFgiaZd-gvHWfQNp2Kbyt Video Abstract

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.

The aim of this narrative review was to assess published growth data for healthy, term, infants consuming extensively hydrolyzed protein-based (EHF), or amino acid-based formulas (AAF). These data may be of use to clinicians managing infants with medical conditions consuming these products. A search was conducted using key terms: amino acid-based, hydrolysate, hydrolyzed, hydrolysed, infant formula, infant formulae or formulas, baby formula, or formulae or formulas, infant, infants, infantile, and growth. Seven controlled, randomized, prospective growth trials of healthy term infants fed EHFs or AAFs at similar time points during the first four months of age met these and other criteria, including that the trial was published in a peer-reviewed journal, subjects were enrolled by ≤14 days of age and were exclusively formula-fed at entry and throughout the duration of the trial, and infants were assessed at regular intervals with weight measures available ideally at 14 days, one, two, three, and four months of age. Results suggested that healthy infants receiving commonly available EHFs and AAFs do not appear to experience accelerated growth as reported for infants fed many standard formulas. Differences in growth patterns were observed with some formulas supporting normative growth patterns during the first four months but others appearing to support markedly lower growth patterns. These observations should be confirmed in well-designed prospective randomized trials. Until that time, it is recommended that EHFs and AAFs be chosen carefully with individual patient needs considered.

Background/Objectives: Obesity during pregnancy is strongly related to increased insulin resistance, and subsequent development of metabolic syndrome-like disorders, such as glucose intolerance, pre-eclampsia, as well as preterm birth, and cesarean delivery. Nutrition can influence the evolution of glycemic response and may help improve adverse pregnancy outcomes and long-term complications. The main objective of the Nutritional Intervention during Gestation and Offspring Health (NIGOHealth) randomized clinical trial (ClinicalTrials.gov Identifier: NCT02285764) was to investigate the potential effects of a low glycemic index/slow digesting (LGI/SD) carbohydrate product on maternal glycemia (glucose AUC at 27+0–28+6 weeks; maternal fasting blood glucose (MFBG) at 34+0–36+0 weeks), and neonatal body composition. Methods: Obese pregnant women were randomized: 230 in the intervention group (IG), who consumed two servings of an LGI/SD study product daily from 15 weeks of pregnancy until delivery, and 102 participants in the Standard of Care (SOC) group. Results: When analyzing baseline characteristics, significant differences were found in glucose metabolic parameters with higher values for IG than for the SOC group, compromising the group’s comparability. Despite this, a statistical analysis was conducted (intention-to-treat analysis/evaluable cohort): no differences were detected regarding maternal blood glucose AUC at 27+0–28+6 weeks, nor for MFBG at 34+0–36+0 weeks. Nonetheless, HbA1c (%) at 34+0–36+0 weeks was significantly lower in the IG vs. the SOC group (5.26 ± 0.03, 5.31 ± 0.04, p = 0.007) after adjusting for baseline conditions. Conclusion: This result might suggest a potential effect of the intervention on Evaluable participants. However, it should be taken with caution, due to the limitations of the study. More RCTs should be carried out to explore the effects of LGI/SD products on glycemic response in obese pregnant women.

Background/Objectives: Anabolic resistance is thought to underlie muscle loss in sarcopenia. Here, we investigated the adjuvant role of beta-hydroxy-beta-methylbutyrate (HMB), a leucine metabolite, on the acute muscle anabolic response to oral protein supplementation in older adults. Methods: A total of 24 community-dwelling older adults (68.5 ± 0.6 years; 13 men, 11 women) were randomized in a cross-over double-blind design to 40 g whey protein (Control) or 40 g whey protein with 3 g calcium–HMB (HMB). Subjects received a primed constant infusion of 13C6 phenylalanine to assess muscle protein synthesis (MPS, by tracer incorporation in myofibrils) and muscle protein breakdown (MPB, via arterio-venous dilution) at baseline and post supplementation. Fasted and 3 h fed-state plasma HMB, aminoacidemia, rates of MPS, MPB, limb and muscle blood flow were measured. Results: In all subjects, both interventions displayed significant increases in MPS in response to feeding [fasted to 3 h-fed change (mean ± SEM, standard error of the mean). Males: control, +0.032 ± 0.006%.h−1; HMB, +0.023 ± 0.004%.h−1; females: control, +0.023 ± 0.006%.h−1; HMB, +0.038 ± 0.006%.h−1, p < 0.05]. In older women, the addition of HMB further enhanced the MPS response (fasted to 3 h-fed change, p = 0.0495) and area under the curve (p = 0.0364) versus protein alone. During the late-fed period, MPB significantly decreased in HMB versus control (p = 0.0298), and this was also observed when subjects were separated by sex (p = 0.0012). Conclusions: High-dose protein bolus feeding increased MPS in older adults. Surprisingly, 40 g whey did not maximize the anabolic response in older women, and HMB further increased the MPS feeding response to protein. HMB further suppressed the MPB feeding response over a longer period of time. Further work is needed to understand the apparent sexual dimorphic MPS response to high protein.

The three-statistician model of monitoring data from an ongoing trial generated strong reactions from the statistical community. At controversy is the recommendation that an independent statistician serves as unblinded liaison to the data monitoring committee (DMC). We share our experience with using an industry statistician as the unblinded liaison in a study on the early treatment of patent ductus arteriosus in premature infants. The DMC membership included an academic consulting statistician. A DMC charter was drawn up laying down the expectations for committee members. The study statisticians were not involved in dealings with the DMC. Only the liaison statistician responsible for generating reports and analyses was aware of the grouped results A versus B. A report generation process was established ensuring a firewall for maintaining confidentiality of results. In certain situations, employing an industry statistician as the unblinded liaison to the DMC is a viable option for monitoring data. Learning Objectives Upon completion of this article, participants should be able to: • Describe an example of using a sponsor statistician as unblinded liaison to the data monitoring committee (DMC) • Present the elements of a DMC charter and a process for preparing DMC reports • Discuss considerations for determining when using an unblinded industry liaison to the DMC is a viable option for monitoring data • Discuss the advantages and disadvantages of using an industry statistician as an unblinded liaison to the DMC Target Audience This article is designed for anyone involved with the clinical trial process including: statisticians, clinical research associates/monitors, clinical data managers, project managers, site coordinators, and data coordinating center personnel, and for potential data monitoring committee memebers including physicians and scientists.

Background Effects of palm olein (POL) on calcium and fat metabolic balance and gastrointestinal (GI) tolerance have been clinically evaluated but its use in combination with palm kernel oil (PKO), and canola oil has not been similarly assessed in infants. Methods Calcium and fat balance and GI tolerance were evaluated in 33 healthy term infants (age = 68-159d) in a randomized, double-blinded, 14d crossover trial at a day care center in Salvador, Brazil; followed by a 4d hospital ward metabolic balance study in 17 of the male subjects. The study compared two commercially available milk-based powdered formulas in Brazil; one containing POL (44% of total fat), PKO (21.7%) and canola oil (18.5%) as predominant fats (PALM), and the other containing none (NoPALM). Occasional human milk (HM) supplementation was allowed at home. Results Formula and HM intakes, and growth were not different (p > 0.05). Calcium absorption (%) for infants fed NoPALM (58.8 ± 16.7%; means ± SD) was higher (p = 0.023) than those fed PALM (42.1 ± 19.2%), but was not significant (p = 0.104) when calcium intake was used as a covariate. Calcium intake was higher (p < 0.001) in NoPALM versus PALM fed infants. However, calcium retention (%) was higher in infants fed NoPALM compared to PALM with (p = 0.024) or without (p = 0.015) calcium intake as a covariate. Fat absorption (%) for NoPALM was greater than PALM fed infants (NoPALM = 96.9 ± 1.2 > PALM = 95.1 ± 1.5; p = 0.020 in Study Period I). Mean rank stool consistency was softer in infants fed NoPALM versus PALM (p < 0.001; metabolic period). Adverse events, spit-up/vomit, fussiness and gassiness were not different (p > 0.05). Formula acceptability was high and comparable for both formula feedings, regardless of HM supplementation. Conclusions Term infants fed PALM based formula (containing palm olein, palm kernel and canola oils) demonstrated lower calcium retention and fat absorption, and less softer stool consistency versus infants fed NoPALM based formula. Study suggested formula fat differences may affect GI function in infants. Clinical trial registration Clinical Trial.Gov # ( http://www.clinicaltrials.gov ): NCT00941564 .

Background Infants and children with chronic diarrhea (CD) often require specialized foods or parenteral nutrition (PN) to achieve adequate nutrient intakes to support growth and development. We assessed the efficacy of an amino acid-based formula (AAF) in supporting growth and improving symptoms in infants and children with CD from multiple etiologies. Methods Two studies were conducted: CD study in children (CD-C) and CD study in infants (CD-I). Each was a single group, baseline-controlled study in which each subject served as his/her own control. At enrollment, all subjects had CD lasting > 2 weeks and had ≥ 4 stools/day. Subjects were fed an AAF for 80 days starting at SD5, and were assessed at SD 28 and 84. Results CD-C: 18 of 19 subjects completed the study. At enrollment, the mean age was 5.6 ± 0.7 years, the most common diagnosis was short bowel syndrome (SBS) (n = 13), and 5 subjects with SBS were on PN. Subjects achieved significant increases in weight-for-age z-scores (p = 0.026). Over 50% of subjects achieved improvements in clinical outcomes targeted most frequently by their physicians. Of the five subjects on PN at enrollment, four had substantial weight gain and four had their PN requirements decreased. CD-I: 22 of 27 subjects completed the study. At enrollment, the mean age was 3.3 ± 0.3 months, the most common diagnosis was food allergy (n = 20), and no subjects were on PN. Subjects achieved significant increases in weight-for-age z-scores (p = 0.0023), significant decreases in the number of stools/day (p = 0.0012), and improvements in stool consistency (p = 0.0024). Over 80% of subjects achieved improvements in the clinical outcomes targeted most frequently by their physicians. Conclusions Infants and children with CD fed an AAF for three months displayed significant improvements in weight-for-age z-scores and clinical symptoms. Children dependent on PN also grew well and four of five decreased their dependence on PN. Trial registration Both trials were registered on ClinTrials.gov (CD-C, NCT01812629 ; CD-I, NCT01820494 ).