Formula Intake Research Articles

Provision of Local Food-Based Formula Using Pila Ampullacea, Tempeh, and Moringa Oleifera Leaves to the Acceptability and Nutrition Intake in Hemodialysis Patients

Background: One of the actions that can be taken to overcome malnutrition in hemodialysis is to improve nutrient intake. It is necessary to provide local food-based formula using Pila ampullacea, tempeh with local soybean, and Moringa oleifera leaves for hemodialysis patients.Objective: To analyze the effect of local food-based formula using Pila ampullacea, tempeh, and Moringa oleifera leaves to the acceptability and nutrition intake in hemodialysis patients.Materials and Methods: This study was carried out in Dr. Sardjito Hospital, Yogyakarta, Indonesia from February to March 2020. Subjects were 54 maintenance hemodialysis patients who met the criteria of study. The independent variable was the provision of local food-based formula, while the dependent variable were the acceptability and nutrition intake.Results: As many as 42.59% of subjects were able to consume all the formula given for three days and 50% of subjects have good acceptance of the local food-based formula. The effect of formula intake to the total intake of energy, carbohydrates, fiber, water, calcium, phosphorus, iron showed p-value <0.05, but p-value ≥0.05 for protein, fat, sodium, and potassium. The effect of the non-formula intake to the total intake for all nutrients showed p-value <0.05.Conclusion: Most of the subjects have a good acceptance of the local food-based formula. Formula intake affects total intake of energy, carbohydrates, fiber, water, calcium, phosphorus, and iron, but does not affect total intake of protein, fat, sodium, and potassium. The total intake for all nutrients was affected by the subject's intake of non-formula sources.

Infants With Different Weight for Age Percentiles May Benefit From Stratified Daily Formula Milk Intake Recommendations

ObjectivesCurrently available guidelines on the daily formula milk requirements of infants, including those from the Institute of Medicine (IOM) and FAO/WHO/UNU, are based on the needs of infants with median body weight and the fact that their growth pattern follows the 50th percentile of the weight-for-age growth curve. Hence, current recommendations might not be sufficiently detailed to meet the needs of infants across the broad spectrum of body weight percentiles. This study aimed to provide stratified recommendations for daily formula milk intake of fully formula-fed infants across different weight-age categories from 0 to 4 months.MethodsAt first, theoretical age- and gender- specific weight ranges were constructed for infants across five predefined weight-for-length percentile categories of the WHO growth standard: small (10th percentile), medium-small (15th to 25th percentiles), medium (50th percentile), medium-large (75th to 85th percentiles), and large (90th percentile) infants. Thereafter, total daily energy requirements for each category were calculated using IOM equation and converted to daily formula milk needs. Subsequently, these stratified age- and weight- formula milk recommendations were compared to actual daily and relative formula milk of infants in these categories retrieved from pooled individual infant formula milk intake (6.174 data points, from 13 clinical intervention studies).ResultsQualitative comparison between theoretical calculation and actual formula milk intakes were both following the same trend with the median daily formula milk volume intake of infants increasing across increasing weight-for-age categories at each timepoint, with larger variations observed in “real life” data compared to theoretical recommendations. Interestingly, the relative daily formula milk volume intake (ml/kg/day) was relatively stable over time but was relatively higher in smaller infants compared to larger infants.ConclusionsQualitative evaluation of both theoretical calculations as well as real-life daily formula intake data showed that one fixed value as formula milk volume intake recommendation may not be optimal for the nutritional needs of infants growing at different percentiles of weight for age.Funding SourcesDanone Nutricia Research.

Hypoallergenicity assessment of an extensively hydrolyzed whey-protein formula in cow's milk allergic infants.

Background Extensively hydrolyzed formulas are recommended for the dietary management of infants with cow's milk allergy (CMA).ObjectivesHypoallergenicity, growth, and gastrointestinal (GI) tolerability of a new extensively hydrolyzed whey‐protein formula (eHWF) in CMA children were assessed.MethodsIn this prospective, randomized, international, multi‐center study (Trial NL3889), 34 children with confirmed CMA (74% IgE‐mediated) underwent a double‐blind, placebo‐controlled food challenge (DBPCFC) with an eHWF developed with non‐porcine enzymes, supplemented with prebiotic short‐chain galacto‐ and long‐chain fructo‐oligosaccharides (0.8 g/L, ratio 9:1), arachidonic acid (0.35/100 g), and docosahexaenoic acid (0.35/100 g). If tolerant to the eHWF, children participated in a 7‐day open food challenge with this eHWF. Anthropometrics and GI tolerability were assessed in an optional 16‐weeks follow‐up.ResultsOf the 34 children who started the DBPCFC with the eHWF, 25 subjects (19 boys, mean age: 61 weeks, 18 with IgE‐mediated CMA) completed the DBPCFC and 7‐day open challenge without major protocol deviations and tested negative at both challenges. One child experienced a late moderate eczematous allergic reaction in the optional follow‐up period, indicating the need for close monitoring of subjects starting new formula. Weight and length gain followed the World Health Organization growth curves. Changes in frequency and consistency of stools upon test formula intake were transient.ConclusionsThe newly developed eHWF is a suitable option in CMA treatment as all subjects tolerated the product. This result is in line with the international criteria for hypoallergenicity (American Academy of Pediatrics) that state that more than 90% of CMA children must tolerate the formula. Use of the formula is also associated with normal growth curves and GI tolerability.Trial registrationTrial NL3889, https://www.trialregister.nl/trial/3889.

Softer More Frequent Stools in Infants With Difficult Stooling Fed Hydrolyzed Protein Formula With Added Prebiotics: Randomized Controlled Trial.

ObjectiveTo evaluate stool consistency in infants with reported hard or infrequent stools fed hydrolyzed protein formula with added prebiotics designed to promote stool softening.MethodsIn this multi-center, double-blind, controlled study, eligible infants (28–300 days of age at enrollment) were randomized to: partially hydrolyzed cow’s milk protein formula (PHF, 75% carbohydrate as lactose; 12 mg Mg/100 kcal; n = 49) or routine intact protein cow’s milk-based infant formula (Control, 92% carbohydrate as lactose; 8 mg Mg/100 kcal; n = 51) over a 14-day period. Both formulas had a prebiotic blend (polydextrose and galactooligosaccharides, 4 g/L; 1:1 ratio). Parent-reported stool consistency (hard = 1 through watery = 5) and other daily outcomes were collected by diary. Endpoint stool consistency (mean score over last 3 days of study feeding) was the primary outcome. Adverse events were recorded.ResultsBaseline stool consistency (Control: 1.4 ± 0.1, PHF: 1.4 ± 0.1) and frequency were similar between groups; the majority had hard (n = 61, 64%) or formed (n = 30, 32%) stools. Stool consistency became softer over Day 1–3 (Control: 2.5 ± 0.1, PHF: 2.6 ± 0.1) and remained similar from Day 4 to 6 through study end (post hoc analysis). For PHF vs Control, endpoint stool consistency was significantly softer (3.4 ± 0.1 vs 3.0 ± 0.1; P = 0.019) and frequency significantly higher (1.5 ± 0.1 vs 1.0 ± 0.1; P = 0.002). Crying, fussing, and appearance of pain during stooling decreased from baseline to study end in both groups. Formula intake, infant fussiness and incidence of adverse events were similar between groups.ConclusionAn infant formula designed to promote stool softening was well-tolerated and associated with softer, more frequent stools in infants with reported hard or infrequent stools.

Analysis of vitamin D status among children under 7 years of age in some regions of China

Objective: To explore current vitamin D status and influential factors of vitamin D deficiency and insufficiency among children under 7 years of age in 11 provinces, autonomous regions or municipalities of China. Methods: According to the "province-city-hospital" sampling technical route, a total of 1 531 healthy children under 7 years of age were sampled from 11 provinces, autonomous regions or municipalities in China by the cluster random sampling method from November 2020 to November 2021. The demographic information, family conditions, behavior and living habits and feeding behaviors were collected using unified questionnaire. Serum 25-hydroxyvitamin D(25(OH)D) levels were measured by liquid chromatography-tandem mass spectrometry. Serum 25(OH)D<30 nmol/L was considered deficient and 30-50 nmol/L was considered insufficient. With 25(OH)D≤50 nmol/L as the dependent variable, multivariate Logistic regression was applied to analyze the association between vitamin D deficiency and insufficiency and potential influential factors. Results: The prevalence of vitamin D deficiency and insufficiency among children under 7 years of age in 11 provinces, autonomous regions or municipalities of China was 14.0% (215/1 531), 3.8% (25/664) and 21.9% (190/867) in 0-<3 and 3-<7 of age years, respectively. Compared to children aged 0-<3 years, children aged 3-<7 years had a 2.6-fold increased risk of vitamin D deficiency and insufficiency (OR=3.60, 95%CI 1.93-6.72, P<0.001). Frequent sunlight exposure (OR=0.46, 95%CI 0.29-0.73, P=0.001), vitamin D supplementation (sometimes, OR=0.33, 95%CI 0.21-0.51, P<0.001; daily, OR=0.20, 95%CI 0.11-0.36, P<0.001) and infant formula intake(4-7 times per weeks, OR=0.43, 95%CI 0.28-0.68, P<0.001) were protective factors for vitamin D deficiency and insufficiency. Conclusion: Vitamin D deficiency and insufficiency are common among children under 7 years of age in 11 provinces, autonomous regions or municipalities of China, which is affected by age, sunlight exposure, vitamin D supplementation and infant formula intake.

Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow‐on formula (FoF) and ready‐to‐eat dairy‐based meals for children up to 35 months of age. As compared to the concentrations naturally present in cow’s milk and concentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an about 10‐fold higher concentration of bmOPN. The intended use levels of the NF would provide bmOPN at a concentration within the range of human milk (hm) OPN. In a 6‐month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns. Considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure (i.e. 36) between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use.

Profiling Growth Patterns of Human Gut Microbes in Response to Preterm Human Milk and Formula

BackgroundThe infant gut microbiota undergoes significant fluxes in microbial composition during the first few years of life. The intestine is colonized shortly after birth with facultative anaerobes, like as Enterococcus, Enterobacter, Streptococcus, and Staphylococcus, which reduce the intestinal oxygen content and create niches for strict anaerobes, like Bifidobacteria, Bacteroides, and Clostridia. The dominant factors which influence the infant gut composition are gestational age and diet. The gut microbiota of preterm infants is characterized by limited microbial diversity and increased levels of facultative anaerobes such as Enterococci, Staphylococci, and Enterbacteriacea (Enterobacter, Escherichia, and Klebsiellaspp.). The gut microbiota is also highly influenced by diet, specifically formula and human milk use. The intake of human milk is associated with increased Bifidobacteria, while the intake of formula correlates with increased Enterobacteriaceae. This study aimed to analyze next‐generation products including preterm formula, human milk‐oligosaccharide term formula, and preterm breastmilk using a culture‐based model.Methods &amp; ResultsWe cultured 8 different Bifidobacteria, 8 Lactobacilli, 8 Streptococcus, 3 Enterococci and 4 Klebsiella strains in a fully defined bacteria media and monitored growth and pH after 20 hrs of anaerobic incubation. Significant differences were identified in strain growth and culture pH between human milk and formula. Human milk significantly elevated the growth of all Bifidobacteria and Lactobacilli. In contrast, human milk supported the growth of three Streptococci and only nominally supported pathobiont Enterococci and Klebsiella strains. Preterm formula elevated the majority of Bifidobacteria and Lactobacilli, as well as several Streptococci. Interestingly, preterm and full‐term formula significantly enhanced the growth of pathobiont strains. Full‐term formula only supported the growth certain commensal microbes, which was in marked contrast to human milk and preterm formula. Using computational modeling, a correlation was observed with human milk oligosaccharide (HMO) degrading glycosyl hydrolase profiles in the genomes of commensal microbes with human milk, but not with formula; confirming the HMO preference of our representative infant commensal microbes.ConclusionsThese findings indicate a unique profile of growth in response to human milk and formula. Since alterations in the infant gut microbiota have linked to childhood health and development, understanding how bacteria differentially utilize whole milk or formula may provide insights into which microbes drive diet‐related microbiota shifts.

Untargeted Metabolomic Assay of Prefrail Older Adults after Nutritional Intervention.

Frailty is a geriatric syndrome causing a reduction in the body’s functional reserves. Proper nutrition may be helpful in delaying transitioning older adults from pre-frail to frailty syndrome. The present study evaluates the nutritional status of pre-frail patients who underwent nutritional intervention and metabolomic changes resulting from this intervention. Sixteen pre-frail patients (68.4 ± 5.5 years old; 81.3% women) were enrolled for nutritional intervention, and twenty-nine robust elderly people (69.3 ± 5.3 years old; 82.8% women) were the control group. Pre-frail patients consumed 1.0 g protein/kg BW/day for eight weeks through diet modification and an additional daily intake of a protein powder formula. Taken measurements included: Nutritional anthropometry, assessment of food intake, and blood serum analysis with an untargeted metabolomic assessment. Protein consumption increased by 25.8%; moreover, significant increases in body weight (+1.2 kg; p = 0.023) and muscle mass index (+0.1 kg/m2; p = 0.042) were also observed. The untargeted metabolomic assay showed a significant increase in arachidonic acid (p = 0.038), and valine (p = 0.008) among pre-frail patients. Increased protein consumption is reflected in improved anthropometric and biochemical parameters of pre-frail patients. Moreover, metabolomic assay can be a useful tool in determining compliance with dietary recommendations.

Evaluation of 2'-Fucosyllactose and Bifidobacterium longum Subspecies infantis on Growth, Organ Weights, and Intestinal Development of Piglets.

Human milk is rich in oligosaccharides that influence intestinal development and serve as prebiotics for the infant gut microbiota. Probiotics and 2’-fucosyllactose (2’-FL) added individually to infant formula have been shown to influence infant development, but less is known about the effects of their synbiotic administration. Herein, the impact of formula supplementation with 2’-fucosyllactose (2’-FL) and Bifidobacterium longum subsp. infantis Bi-26 (Bi-26), or 2’-FL + Bi-26 on weight gain, organ weights, and intestinal development in piglets was investigated. Two-day-old piglets (n = 53) were randomized in a 2 × 2 design to be fed a commercial milk replacer ad libitum without (CON) or with 1.0 g/L 2’-FL. Piglets in each diet were further randomized to receive either glycerol stock alone or Bi-26 (109 CFU) orally once daily. Body weights and food intake were monitored from postnatal day (PND) 2 to 33/34. On PND 34/35, animals were euthanized and intestine, liver and brain weights were assessed. Intestinal samples were collected for morphological analyses and measurement of disaccharidase activity. Dry matter of cecum and colon contents and Bifidobacterium longum subsp. infantis abundance by RT-PCR were also measured. All diets were well tolerated, and formula intake did not differ among the treatment groups. Daily body weights were affected by 2’-FL, Bi-26, and day, but no interaction was observed. There was a trend (p = 0.075) for greater total body weight gain in CON versus all other groups. Jejunal and ascending colon histomorphology were unaffected by treatment; however, there were main effects of 2’-FL to increase (p = 0.040) and Bi-26 to decrease (p = 0.001) ileal crypt depth. The addition of 2’-FL and/or Bi-26 to milk replacer supported piglet growth with no detrimental effects on body and organ weights, or intestinal structure and function.

Evidence for Better Neurodevelopment With Iron Supplementation

Evidence for Better Neurodevelopment With Iron Supplementation

Survey of AREDS2 Formula Intake in Korean Patients with Age-related Macular Degeneration

Purpose: To investigate the use of second AREDS2 formula in patients with intermediate or advanced age-related macular degeneration.Methods: A prospective survey was conducted between December 2019 and July 2020. The questionnaire consisted of 24 questions on demographics, disease perception, and formula intake.Results: The survey included 100 patients (males, 56%; age [&gt;60 years], 89%). We found that 66%, 84%, and 93% of patients had a good understanding of their disease, had stopped smoking, and were aware of the need for antioxidant supplements; 58% of patients were aware of the supplement they were prescribed, and 63.8% (37% of total) were using the AREDS2 formula. Only 8% of patients had knowledge regarding the supplement ingredients, and 91% consumed the supplement daily. Patients with long disease duration used supplements less frequently (&lt;i&gt;p&lt;/i&gt; &lt; 0.05). Older patients and those with a low education level had a limited perception of the disease (&lt;i&gt;p&lt;/i&gt; &lt; 0.05).Conclusions: In this prospective survey, some patients consumed supplements other than the AREDS2 formula. Further studies are required to determine ways to increase the use of the AREDS2 formula.

Explainable machine learning model for predicting the occurrence of postoperative malnutrition in children with congenital heart disease

Malnutrition is persistent in 50%-75% of children with congenital heart disease (CHD) after surgery, and early prediction is crucial for nutritional intervention. The aim of this study was to develop and validate machine learning (ML) models to predict the malnutrition status of children with CHD. We used explainable ML methods to provide insight into the model's predictions and outcomes. This prospective cohort study included consecutive children with CHD admitted to the hospital from December 2017 to May 2020. The cohort data were divided into the training and test data sets based on the follow-up time. The outcome of the study was CHD child malnutrition 1 year after surgery, the primary outcome was an underweight status, and the secondary outcomes were stunted and wasting status. We used five ML algorithms with multiple features to construct prediction models, and the performance of these ML models was measured by an area under the receiver operating characteristic curve (AUC) analysis. We also used the permutation importance and SHapley Additive exPlanations (SHAP) to determine the importance of the selected features and interpret the ML models. We enrolled 536 children with CHD who underwent complete repair. The proportions of children with an underweight, stunted, or wasting status 1 year after surgery were 18.1% (97/536), 12.1% (65/536), and 17.5% (94/536), respectively. All patients contributed to the generation of 115 useable features, which allowed us to build models to predict malnutrition. Five prediction algorithms were used, and the XGBoost model achieved the greatest AUC in all outcomes. The results obtained from the permutation importance and SHAP analyses showed that the 1-month postoperative WAZ-score, discharge WAZ score and preoperative WAZ score were the top 3 important features in predicting an underweight status in the XGBoost algorithm. Regarding the stunted status, the top 3 important features were the 1-month postoperative HAZ score, discharge HAZ score, and aortic clamping time. Regarding the wasting status, the top 3 important features were the hospital length of stay, formula intake, and discharge WHZ-score. We also used a narrative case report as an example to describe the clinical manifestations and predicted the primary outcomes of two children. We developed an ML model (XGBoost) that provides accurate early predictions of malnutrition 1-year postoperatively in children with CHD. Because the ML model is explainable, it may better enable clinicians to better understand the reasoning underlying the outcome. Our study could aid in determining individual treatment and nutritional follow-up strategies for children with CHD.

The risk variant of CDKAL1 (rs7756992) impairs fasting glucose levels and insulin resistance improvements after a partial meal-replacement hypocaloric diet

BackgroundThe CDKAL1 (CDK5 Regulatory Subunit Associated Protein 1 Like 1) gene encodes cyclin-dependent kinase 5 (CDK5) regulatory subunit-associated proten1 like 1. This protein has been shown to contribute to the glucose-dependent regulation of insulin secretion in pancreatic islets. AimsThe aim of our study was to analyze the effects of the rs7756992 genetic variant of CDKAL1 gene on fasting glucose and insulin resistance after weight loss secondary to partial meal replacement hypocaloric diet (pMRHD). MethodsThis was a non-randomized, single-treatment study with a formula-diet in 44 obese subjects. The patients received nutritional education and a modified diet with two intakes of a normocaloric hyperproteic formula for 3-months. Anthropometric parameter and biochemical profile were measured at basal time and after 3 months. The variant of CDKAL1 gene rs7756992 was assessed. ResultsThe following genetic distribution was observed; [27AA (61.3%), 12 AG (27.3%) and 5 GG (11.4%)]. After the pMRHD, body weight, the body mass index (BMI), fat mass, waist circumference and blood pressure decreased in both genotypes. Non-G allele carriers showed a significant improvement in fasting glucose levels (AA vs. AG + GG) (−6.1 ± 1.4 md/dl vs. −1.2 ± 0.7 mg/dl; p = 0.01), fasting insulin levels (−3.6 ± 0.2 mU/l vs. −1.3 ± 0.6 mU/l; p = 0.02) and HOMA-IR (−1.2 ± 0.2 units vs. −0.3 ± 0.2 units; p = 0.01). Fasting plasma glucose levels were higher in G allele carriers than non G allele carriers. ConclusionsOur data suggest that the genetic variant (rs7756992) of CDKAL1 gene is associated with glycaemic status after a pMRHD, with greater improvements in fasting glucose, insulin and HOMA-IR in subjects without the G allele.

Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial

BackgroundOptimal protein level in hypoallergenic infant formulas is an area of ongoing investigation. The aim was to evaluate growth of healthy term infants who received extensively hydrolyzed (EH) or amino acid (AA)-based formulas with reduced protein.MethodsIn this prospective, multi-center, double-blind, controlled, parallel group study, infants were randomized to receive a marketed EH casein infant formula at 2.8 g protein/100 kcal (Control) or one of two investigational formulas: EH casein formula at 2.4 g protein/100 kcal (EHF) or AA-based formula at 2.4 g total protein equivalents/100 kcal (AAF). Control and EHF each had 2 × 107 CFU Lactobacillus rhamnosus GG/100 kcal. Anthropometrics were measured and recall of formula intake, tolerance, and stool characteristics was collected at 14, 30, 60, 90, 120 days of age. Primary outcome was weight growth rate (g/day) between 14 and 120 days of age (analyzed by ANOVA). Medically confirmed adverse events were recorded throughout the study.ResultsNo group differences in weight or length growth rate from 14 to 120 days were detected. With the exception of significant differences at several study time points for males, no group differences were detected in mean head circumference growth rates. However, mean achieved weight, length, and head circumference demonstrated normal growth throughout the study period. No group differences in achieved weight or length (males and females) and head circumference (females) were detected and means were within the WHO growth 25th and 75th percentiles from 14 to 120 days of age. With the exception of Day 90, there were no statistically significant group differences in achieved head circumference for males; means remained between the WHO 50th and 75th percentiles for growth at Days 14, 30, and 60 and continued along the 75th percentile through Day 120. No differences in study discontinuation due to formula were detected. The number of participants for whom at least one adverse event was reported was similar among groups.ConclusionsThis study demonstrated hypoallergenic infant formulas at 2.4 g protein/100 kcal were safe, well-tolerated, and associated with appropriate growth in healthy term infants from 14 to 120 days of age.Trial registrationClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT01354366. Registered 13 May 2011.

Dietary compliance in a randomized double-blind infant feeding trial during infancy aiming at prevention of type 1 diabetes.

The international Trial to Reduce IDDM in the Genetically at Risk (TRIGR) tested the hypothesis whether extensively hydrolyzed casein‐based versus regular cow's milk‐based infant formula reduces the risk of type 1 diabetes. We describe dietary compliance in the trial in terms of study formula intake, feeding of nonrecommended foods, and serum cow's milk antibody concentration reflecting intake of cow's milk protein among 2,159 eligible newborn infants with a biological first‐degree relative affected by type 1 diabetes and with HLA‐conferred susceptibility to type 1 diabetes. The participating infants were introduced to the study formula feeding at the median age of 15 days with a median duration of study formula use of 63 days. During the intervention, 80% of the infants received study formula. Of these, 57% received study formula for at least 2 months. On average, 45.5 l of study formula were used per infant. Only 13% of the population had received a nonrecommended food by the age of 6 months. The dietary compliance was similar in the intervention and control arm. The reported cow's milk consumption by the families matched very well with measured serum casein IgA and IgG antibody concentration. To conclude, good compliance was observed in this randomized infant feeding trial. Compliance varied between the regions and those infants who were breastfed for a longer period of time had a shorter exposure to the study formula. High dietary compliance in infant feeding trial is necessary to allow accurate interpretation of study results.

La presencia de la variante de riesgo de CDKAL1 (rs7756992) altera los niveles de glucosa en ayunas y la resistencia a la insulina después de una dieta hipocalórica con reemplazo parcial de comidas

BackgroundThe CDKAL1 (CDK5 Regulatory Subunit Associated Protein 1 Like 1) gene encodes cyclin-dependent kinase 5 (CDK5) regulatory subunit-associated proten1 like 1. This protein has been shown to contribute to the glucose-dependent regulation of insulin secretion in pancreatic islets. AimsThe aim of our study was to analyze the effects of the rs7756992 genetic variant of CDKAL1 gene on fasting glucose and insulin resistance after weight loss secondary to partial meal replacement hypocaloric diet (pMRHD). MethodsThis was a non-randomized, single-treatment study with a formula-diet in 44 obese subjects. The patients received nutritional education and a modified diet with two intakes of a normocaloric hyperproteic formula for 3-months. Anthropometric parameter and biochemical profile were measured at basal time and after 3 months. The variant of CDKAL1 gene rs7756992 was assessed. ResultsThe following genetic distribution was observed; [27AA (61.3%), 12 AG (27.3%) and 5 GG (11.4%)]. After the pMRHD, body weight, the body mass index (BMI), fat mass, waist circumference and blood pressure decreased in both genotypes. Non-G allele carriers showed a significant improvement in fasting glucose levels (AA vs. AG + GG) (-6.1 ± 1.4 md/dL vs. -1.2 ± 0.7 mg/dl; p = 0.01), fasting insulin levels (-3.6 ± 0.2 mU/L vs. -1.3 ± 0.6 mU/L; p = 0.02) and HOMA-IR (-1.2 ± 0.2 units vs. -0.3 ± 0.2 units; p = 0.01). Fasting plasma glucose levels were higher in G allele carriers than non G allele carriers. ConclusionsOur data suggest that the genetic variant (rs7756992) of CDKAL1 gene is associated with glycaemic status after a pMRHD, with greater improvements in fasting glucose, insulin and HOMA-IR in subjects without the G allele.

Impact of an Infant Formula Containing a Novel Fat Blend (Cow’s Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns

Introduction: Recently, new commercial infant formulas have been composed considering novel fat blends and oligosaccharides to better resemble the fatty acid (FA) composition and stereospecific distribution (e.g., increased amount of ß-palmitate) as well as probiotics content of human breast milk. We hypothesized that these newly composed infant formulas may decrease fecal FA soap excretion and may positively affect erythrocyte FA profiles compared with regular formulas. Methods: Healthy infants were randomly assigned to receive a high-sn-2-palmitate formula (>25% of the PA is esterified to the sn-2 position of the glycerol backbone, verum: n = 30) or a “standard” formula containing <10% of PA in sn-2 position and no oligosaccharides (control: n = 27); a non-randomized group of breast-fed infants served as control. Anthropometric data of the infants (body weight, recumbent length, and head circumference) were recorded at inclusion (visit 1) and 6 and 12 weeks after onset of intervention (visits 2 and 3). Blood samples for erythrocyte FA analysis (gas chromatography) were taken at visits 1 and 2; stool samples were collected at visit 2. Results: Quantitative formula intake (mL/kg body weight × day) at visit 2 (verum: 155 ± 30, control: 164 ± 30) and visit 3 (verum: 134 ± 26, control: 134 ± 21) was comparable. Six weeks after onset of intervention, stool total FA soaps, palmitate soaps, and total FAs were similar in both formula-fed groups but significantly higher than in breast-fed infants. During the 6-week intervention, erythrocyte palmitate decreased significantly from baseline in all 3 groups with no group differences (verum: 29.20 ± 1.17 to 27.12 ± 0.66, control: 29.88 ± 2.00 to 27.01 ± 0.94, breast-fed: 30.20 ± 0.86 to 26.84 ± 0.98). For selected FAs, significant changes over time in verum and control group were obvious but without formula effects. Some variations in the FA profile of breast-fed infants compared to both verum and control groups were observed. Conclusions: In contrast to our hypothesis, feeding a newly composed infant formula based on a fat blend with 25% of PA in the sn-2 position of triacylglycerols and supplemented with a prebiotic could not decrease insoluble FA soap excretion compared with a standard product; in this respect, breastfeeding is obviously the best choice. Surprisingly, erythrocyte FA profiles were comparable in formula-fed and breast-fed infants; obvious alterations in FA composition of the respective fat sources and structure did not affect FA incorporation into membranes. Caution should be, however, exercised in drawing robust conclusions in the absence of larger, adequately powered intervention studies.

A red pomegranate fruit extract-based formula ameliorates anxiety/depression-like behaviors via enhancing serotonin (5-HT) synthesis in C57BL/6 male mice

This study investigated the anti-anxiety/anti-depression potential of a formula containing red pomegranate fruit extract (RPFE; 40%, m/m), Lactobacillus rhamnosus (JB-1) (34%, m/m), magnesium gluconate (25%, m/m) and vanillin (1%, m/m). The RPFE formula (dose: 2.0, 1.5 or 1.0mg/gday) reversed behavioral dysfunctions and body weight gain induced by chronic restraint stress combined with corticosterone injection in C57BL/6 male mice. The RPFE formula exhibited the abilities to normalize the levels of serum inflammatory cytokines (NF-κB, TNF-α, IL-6, IL-1β and IFN-γ) and malondialdehyde (MDA), and activities of superoxide dismutase (SOD), catalase (CAT) and nitric oxide synthase (NOS), as well as relieve the injury of hippocampal neurons. The serotonin (5-HT) levels in hippocampus were increasingly enhanced, which might be mediated by reducing the activity of indoleamine-2,3-dioxygenase (IDO) and increasing the activity of tryptophan hydroxylase (TPH). Thus, the neuroprotective and ameliorating effects on anxiety/depression-like behaviors resulting from the RPFE formula ingestion were possibly related to serotonergic activation, which might be mediated via anti-inflammatory and anti-oxidant actions.

Growth, Tolerance, and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula with Added 2'-FL Fucosyllactose (2'-FL) Human Milk Oligosaccharide.

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.

Oral exclusive enteral nutrition for induction of clinical remission, mucosal healing, and improvement of nutritional status and growth velocity in children with active Crohn's disease - a prospective multicentre trial.

IntroductionUndernutrition and growth failure are common problems in paediatric patients with active Crohn’s disease (CD).AimThe aim of exclusive enteral nutrition (EEN) commencement is not only to induce clinical remission and promote mucosal healing but also to initiate weight and growth gain, especially in patients with poor nutritional status. We assessed the effectiveness of treatment with EEN and its impact on nutritional status in children with active CD.Material and methodsTwenty children (male/female: 14/6) in median age of 14 years with active CD had EEN with polymeric industrial diet (Modulen IBD) applied for 6 weeks. The daily caloric intake was established according to the age and nutritional status. In patients with undernutrition, it was increased to 120–150% relative to recommendations for the healthy peers. The Paediatric CD activity index (PCDAI) – a marker of clinical remission, faecal calprotectin (FCP) – a marker of mucosal healing (MH), and nutritional status were assessed at baseline and 4 weeks following the end of the therapy (week 10).ResultsIn the studied group the mean decrease in PCDAI score was statistically significant (from 25.6 ±12 to 5.4 ±10, p < 0.05). Full remission (defined as PCDAI < 10) was achieved in 65% of patients, and clinical response in another 30% of them. Only 5% of children did not respond to the treatment. Mean decline in FCP level was statistically significant as well (from 3380 ±7746 to 1046.6 ±1219, p < 0.05). All patients, apart from one who was fed with a nasogastric tube, accepted oral intake of industrial formula. EEN was generally well tolerated. Initially, in 20% of patients the symptoms of intolerance to the industrial diet were observed, but they receded within the first days of the therapy. The recommended daily intake of the formula was achieved in 95% of children. Only one child was unable to intake the prescribed amount of the diet due to intolerance. At baseline, undernutrition was observed in 30% of patients, which was established by a body mass index (BMI) score below the third percentile according to the recommended charts for the Polish paediatric population. In all patients, improvement in BMI status was reported at the end of the treatment. The mean increase in BMI score was 0.91, and it was greater in the malnourished group compared to patients with normal nutritional status (1.19 vs. 0.62). After the treatment two-thirds of children with malnutrition achieved a BMI score within the normal range. In 25% of patients, growth deficit was observed (defined as growth below the third percentile according to the Polish charts) before the EEN introduction. An increase in body height was obtained generally in 55% of children and in 80% of those with initial growth failure. The mean increase in growth was 1 cm, and it was greater in the group with initial growth deficit relative to patients with baseline normal height (1.5 cm vs. 0.8 cm, respectively).ConclusionsA 6-week course of oral EEN was an effective and well-tolerated method of treatment in children with active CD. Nutritional therapy not only induced full clinical remission and led to decline in FCP level (as a marker of MH) in the majority of patients, but also contributed to the improvement in their nutritional status and growth velocity. These are very important observations because proper development is crucial for paediatric CD patients.