Nutricia Research (Netherlands)

Traditional Indian cereal-based breakfast items have high glycemic index (GI) contributing to postprandial (PP) glucose spikes. Use of diabetes-specific protein supplement (DSPS) may reduce glycemic excursions. The study aimed to evaluate the effect of partially replacing breakfast with DSPS (Protinex Diabetes Care) on PP glycemic response. Forty-two persons with type2 diabetes mellitus (T2DM) participated in this randomized, controlled, open-label, crossover study. Participants consumed a test breakfast (DSPS in 200ml milk + reduced portion of popular Indian savory breakfast (upma/poha)) or isocaloric control breakfast (upma/poha) for 5days, with 3-day washout. PP glucose and insulin were assessed on the first day of intervention at baseline, 30, 60, 90, 120, 150, and 180min after breakfast to calculate incremental area under the curve (iAUC0-3h) and delta peak (ΔCmax). During in-home use, macronutrient intake was assessed using dietary recalls, and glycemic variability (GV) was assessed using continuous glucose monitoring (CGM). Glucose iAUC0-3h and ΔCmax were 59% and 46% lower in test vs control, respectively. Insulin iAUC0-3h and ΔCmax did not differ significantly. During the test period, protein intake was significantly higher by 8.8g; mean amplitude of glycemic excursions (MAGE)-a GV metric-was significantly lower. There were no gastrointestinal or adverse events. DSPS was well accepted by participants. DSPS as a partial breakfast replacement improves blood glucose control without significantly impacting insulin response. In a real-world setting, DSPS enhances protein intake and reduces GV. These findings support DSPS as a practical, well-tolerated strategy for improving glycemic control and macronutrient intake balance in people with T2DM. The trial was registered with Clinical Trials Registry India (CTRI) CTRI/2024/08/072006 and has been registered in the International Clinical Trials Registry Platform (ICTRP).

Microbiome research focusing on late and moderate preterm infants (LMPT; 32 to 36 weeks gestation) is limited, despite rising LMPT births, large healthcare burdens, and increased risks of multiple morbidities, potentially microbially related. In this longitudinal cohort study, 16S rRNA gene sequencing was used to analyze 371 stool and 402 saliva samples from 160 LMPT infants, collected at five time points between birth and 12 months corrected age (CA), to describe spatial and temporal variability in gut and oral microbiomes. Paired stool and saliva samples (n = 337) were analyzed for potential microbial relationships. Early LMPT samples (up to 60 days of life; DOL) were also compared with data from seven extremely preterm infants (EP; <28 weeks gestation; stool n = 14, saliva n = 14). LMPT stool and saliva were composed of distinct microbial communities at each time point, and both sample types showed increasing alpha diversity over time. Stool was initially dominated by Escherichia/Shigella, Klebsiella, and Streptococcus, with Bifidobacterium becoming dominant from term equivalent age (TEA). Contrarily, saliva was dominated by Streptococcus throughout the first year, with early contributions from Staphylococcus and later Veillonella. LMPT infants had higher stool and lower saliva diversity compared with EP infants. Both sample types from EP infants were taxonomically distinct from LMPTs, with Escherichia/Shigella dominating both EP sample types throughout the first 60 DOL. The results highlight the unique trajectories of LMPT microbiomes and emphasize the role of gestational maturity in shaping microbial communities.IMPORTANCEThe oral and gut microbiome develops from birth and plays important roles in health. This has been well studied in extremely preterm infants (EP; born <32 weeks gestation) and term infants (born >38 weeks gestation), but there is a paucity of research describing oral and gut microbiome development in late and moderate preterm infants (LMPT; 32 to 36 weeks gestation). Our study analyzed microbiome development in 160 LMPT infants from birth to 12 months corrected age. The results showed distinct microbial communities in stool and saliva, with increasing alpha diversity and niche specification over time. LMPT infants' gut microbiome became dominated by Bifidobacterium by month 3, while the oral community was consistently dominated by Streptococcus. These results highlight that LMPT infants have gut and oral microbiome development that is more like term infants than EP infants, which has important implications for the care of LMPT infants.

Deviations from normal postnatal growth patterns in infancy and early childhood are indicators to predict future negative health outcomes and to direct early interventions, such as changes in feeding regimens. The objective of our study was to examine potential differences in BMI trajectory during the first year of life between infants of different birth weight categories. A pooled, fully anonymized dataset was constructed based on individual subject data of 4,777 participants from 12 clinical studies in which infant growth outcome measurements were collected at several timepoints during their first year of life. A BMI model was constructed using a joint bivariate growth model for weight and height (and their deterministic relationship). A Bayesian approach was used to explore birthweight category-specific differences in BMI development. Our main finding is that the BMI trajectories of the birthweight categories (particularly the small vs large groups) continue to show differences over time, although these differences become less apparent after the first months of age. Both weight and length continue to show consistent differences between categories across the first year of life. A more detailed analysis including the effect of region and gender, showed differential BMI patterns among the three birthweight categories over time across the different subgroups (combinations of region and gender).

Degenerative joint disease osteoarthritis (OA) is characterized by the degeneration of cartilage, synovial inflammation and low-grade systemic inflammation in association with microbial dysbiosis and intestinal barrier defects. Butyrate is known for its anti-inflammatory and barrier protective effects and might benefit OA patients. In a double-blind placebo-controlled randomized trial, the effects of four to five weeks of oral treatment with sustained-release (SR) butyrate tablets (600 mg/day) on systemic inflammation and immune function were studied in hand OA patients. Serum markers for systemic inflammation and lipopolysaccharide (LPS) leakage were measured and ex vivo stimulation of whole blood or peripheral blood mononuclear cells (PBMCs) was performed at baseline and after treatment. Butyrate treatment did not affect the serum markers nor the cytokine release of ex vivo LPS-stimulated whole blood or PBMCs nor the phenotype of restimulated monocytes. By contrast, butyrate treatment reduced the percentage of activated T helper (Th) cells and the Th17/Treg ratio in αCD3/CD28-activated PBMCs, though cytokine release upon stimulation remained unaffected. Nevertheless, the percentage of CD4+IL9+ cells was reduced by butyrate as compared to the placebo. In both groups, the frequency of Th1, Treg, Th17, activated Th17, CD4+IFNγ+ and CD4+TNFα+ cells was reduced. This study shows a proof of principle of some immunomodulatory effects using a SR butyrate treatment in hand OA patients. The inflammatory phenotype of Th cells was reduced, as indicated by a reduced percentage of Th9 cells, activated Th cells and improved Th17/Treg balance in ex vivo αCD3/CD28-activated PBMCs. Future studies are warranted to further optimize the butyrate dose regime to ameliorate inflammation in OA patients.

BackgroundIngestion of prebiotics during pregnancy and lactation may have immunomodulatory benefits for the developing fetal and infant immune system and provide a potential dietary strategy to reduce the risk of allergic diseases. ObjectiveThe aim of this trial was to determine whether maternal supplementation with dietary prebiotics reduces the risk of allergic outcomes in infants with hereditary risk. MethodsWe undertook a double-blind, randomized controlled trial in which pregnant women were allocated to consume prebiotics (14.2g daily of galacto-oligosaccharides and fructo-oligosaccharides in ratio 9:1) or placebo (8.7g daily maltodextrin) powder from <21 weeks gestation until 6-months postnatal during lactation. Eligible women had infants with a first-degree relative with a history of medically diagnosed allergic disease. The primary outcome was infant medically diagnosed eczema by 1-year of age, and secondary outcomes included allergen sensitization, food allergy, and recurrent wheeze by 1-year of age. Results652 women were randomized between June 2016 and November 2021 (n=329 prebiotics, n=323 placebo). There was no significant difference between groups in the percentage of infants with medically diagnosed eczema by 1-year of age (prebiotics 31.5% (103/327 infants) compared to placebo 32.6% (105/322 infants); adjusted relative risk 0.98 (95% CI 0.77, 1.23; p=0.84). Secondary outcomes and safety measures also did not significantly differ between groups. ConclusionWe found little evidence that maternal prebiotics supplementation during pregnancy and lactation reduces the risk of infant medically diagnosed eczema by 1-year of age in infants who are at hereditary risk of allergic disease.

IntroduçãoO paciente oncológico vivencia fatores estressores que perpassam a rotina de tratamento, tais como fila de espera e demora na dispensação da medicação.1,2 Diante dessas dificuldades, é importante que haja inovações tecnológicas que mapeei barreiras no processo de atendimento, proporcionando maior qualidade no atendimento em saúde. Sabendo dessas problemáticas, o estudo tem como objetivo relatar a criação de uma tecnologia – Stopwatch - que acompanha a jornada do paciente em um ambulatório oncológico.MétodoA tecnologia Stopwatch foi criada pela colaboração dos setores de enfermagem e da tecnologia da informação para identificar gargalos que causam atrasos na dispensação de medicamentos. Na primeira fase, foi realizado um mapeamento do tempo desde a manipulação do medicamento pela equipe da farmácia até sua entrega no posto de enfermagem. Os setores foram:-Farmácia Satélite -> Enfermagem: 12 minutos para liberar a punção e pré-medicação.-Farmácia Produção -> Enfermagem: 45 min para liberar quimioterapia.-Enfermagem -> Alta.Na segunda etapa, a tecnologia foi utilizada para monitorar o tempo de entrega de cada setor conforme os acordos estabelecidos. Na terceira etapa, foi implementado um painel de controle em tempo real, onde a equipe é notificada em caso de atraso, permitindo a prestação de justificativas para mapear as barreiras.ResultadoApós mapear o processo, identificamos que a farmácia satélite tinha um índice de atraso de 16,71%, enquanto a farmácia de produção registrava 19,67%. As principais causas de atraso foram dificuldade de rede venosa, liberação de múltiplos protocolos e alta demanda simultânea de pacientes. Três meses após a implantação da ferramenta, foram reduzidos para aproximadamente 9,69% na farmácia satélite e 5,61% na farmácia de produção, indicando uma melhoria significativa.ConclusãoO uso da tecnologia foi possível aprimorar o entendimento do desempenho, identificar entraves à eficiência, melhorar a motivação e facilitar a tomada de decisões através de previsões, além de diminuir o tempo de espera dos pacientes de forma segurança e com qualidade no atendimento. O Stopwatch se mostrou uma inovação que capaz de otimizar a eficiência dos sistemas de saúde, podendo ser disseminado em outros contextos de saúde.