Health and nutrition claims for infant formula: international cross sectional survey.

OBJECTIVES: To review available health and nutrition claims for infant formula products in multiple countries and to evaluate the validity of the evidence used for substantiation of claims. DESIGN: International cross sectional survey. SETTING: Public facing and healthcare professional facing company owned or company managed formula industry websites providing information about products marketed for healthy infants delivered at full term in 15 countries: Australia, Canada, Germany, India, Italy, Japan, Nigeria, Norway, Pakistan, Russia, Saudi Arabia, South Africa, Spain, the United Kingdom, and the United States in 2020-22. MAIN OUTCOME MEASURES: Number and type of claims made for each product and ingredient. References cited were reviewed and risk of bias was assessed for registered clinical trials using the Cochrane risk of bias tool, and for systematic reviews using the Risk Of Bias in Systematic reviews tool. RESULTS: 757 infant formula products were identified, each with a median of two claims (range from 1 (Australia) to 4 (US)), and 31 types of claims across all products. Of 608 products with ≥1 claims, the most common claim types were "helps/supports development of brain and/or eyes and/or nervous system" (323 (53%) products, 13 ingredients), "strengthens/supports a healthy immune system" (239 (39%) products, 12 ingredients), and "helps/supports growth and development" (224 (37%) products, 20 ingredients). 41 groups of ingredients were associated with ≥1claims, but many claims were made without reference to a specific ingredient (307 (50%) products). The most common groups of ingredients cited in claims were long chain polyunsaturated fatty acids (278 (46%) products, 9 different claims); prebiotics, probiotics, or synbiotics (225 (37%) products, 19 claims); and hydrolysed protein (120 (20%) products, 9 claims). 161/608 (26%) products with ≥1 claims provided a scientific reference to support the claim-266 unique references were cited for 24 different claim types for 161 products. The reference types most frequently cited were clinical trials (50%, 134/266) and reviews (20%, 52/266). 28% (38/134) of referenced clinical trials were registered, 14% (19/134) prospectively. 58 claims referred to 32 registered clinical trials, of which 51 claims (27 trials) related to a randomised comparison. 46 of 51 claims (90%) referenced registered clinical trial outcomes at high risk of bias, and all cited systematic reviews and pooled analyses, carried a high risk of bias. CONCLUSIONS: Most infant formula products had at least one health and nutrition claim. Multiple ingredients were claimed to achieve similar health or nutrition effects, multiple claims were made for the same ingredient type, most products did not provide scientific references to support claims, and referenced claims were not supported by robust clinical trial evidence.

Factors associated with breast-feeding initiation and continuation in Canadian-born and non-Canadian-born women: a multi-centre study.

OBJECTIVE: To identify factors associated with breast-feeding initiation and continuation in Canadian-born and non-Canadian-born women. DESIGN: Prospective cohort of mothers and infants born from 2008 to 2012: the Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study. SETTING: General community setting in four Canadian provinces. PARTICIPANTS: In total, 3455 pregnant women from Vancouver, Edmonton, Winnipeg and Toronto between 2008 and 2012. RESULTS: Of 3010 participants included in the current study, the majority were Canadian-born (75·5 %). Breast-feeding initiation rates were high in both non-Canadian-born (95·5 %) and Canadian-born participants (92·7 %). The median breast-feeding duration was 10 months in Canadian-born participants and 11 months in non-Canadian-born participants. Among Canadian-born participants, factors associated with breast-feeding initiation and continuation were older maternal age, higher maternal education, living with their partner and recruitment site. Rooming-in during the hospital stay was also associated with higher rates of breast-feeding initiation, but not continuation at 6-month postpartum. Factors associated with non-initiation of breast-feeding and cessation at 6-month postpartum were maternal smoking, living with a current smoker, caesarean birth and early-term birth. Among non-Canadian-born participants, maternal smoking during pregnancy was associated with lower odds of breast-feeding initiation and lower odds of breast-feeding continuation at 6 months, and older maternal age and recruitment site were associated with breast-feeding continuation at 6 months. CONCLUSIONS: Although Canadian-born and non-Canadian-born women in the CHILD cohort have similar breast-feeding initiation rates, breast-feeding initiation and continuation are more strongly associated with socio-demographic characteristics in Canadian-born participants. Recruitment site was strongly associated with breast-feeding continuation in both groups and may indicate geographic disparities in breast-feeding rates nationally.

Breastfeeding and Postpartum Glucose Regulation Among Women With Prior Gestational Diabetes: A Systematic Review.

BACKGROUND: Gestational diabetes mellitus is associated with adverse maternal and fetal outcomes and increases subsequent risk of Type 2 diabetes. Researchers have shown that breastfeeding may reduce diabetes risk in women with recent gestational diabetes. RESEARCH AIM: To assess association between infant feeding and postpartum glucose tolerance in mothers with recent gestational diabetes within 1 year postpartum. METHODS: A literature search was performed up to December 31, 2019, retrieving articles related to infant feeding, gestational diabetes, and postpartum glucose regulation in four major databases (PubMed, Cochrane, CINAHL, and Embase). Methodological quality was assessed using tools from the United States National Institutes of Health and the National Heart, Lung, and Blood Institute. RESULTS: The search yielded 15 cohort studies meeting the selection criteria. Of the 15 studies, 13 (86.7%) examined the influence of breastfeeding on postpartum glycemic status, and eight (53.4%) compared the mean blood glucose values between breastfeeding and non-breastfeeding participants. Of the 13 studies that compared postpartum glycemic status, nine (60%) of the research teams found that breastfeeding lowered rates of impaired glucose tolerance, and four (26.7%) showed no significant change. In eight of the studies reporting mean blood glucose values, six (75%) reported significantly lower fasting plasma glucose in breastfeeding participants, with reductions ranging from 3.7 to 7.4 mg/dL (0.2-0.4 mmol/L). CONCLUSION: Breastfeeding has been associated with improved postpartum glucose regulation in mothers with gestational diabetes. In pregnant women with gestational diabetes, breastfeeding may reduce the risk of Type 2 diabetes, and women with gestational diabetes should be strongly encouraged and supported to breastfeed.

Parents of children with food allergy: A qualitative study describing needs and identifying solutions.

BACKGROUND: Parents experience a wide range of emotions, specifically stress and anxiety, when their child receives a diagnosis of a food allergy. Managing this health condition and coping with emotions require professional and peer support. Currently, there is a lack of resources and a lack of awareness of the resources that are required to help assist parents in managing their child's food allergy. OBJECTIVE: To describe parental experiences when caring for a child with food allergy and to review the resources parents need to manage living with a child with food allergy and more specifically how they would want these resources delivered. METHODS: A total of 7 semistructured focus groups were conducted in British Columbia, Canada. Parents were asked to describe their experiences with managing their child's food allergy and identify helpful resources. RESULTS: A total of 40 parents (33 females) participated in the focus groups. Participant demographics were collected. The following 3 main themes emerged: (1) anxiety (an emotional roller coaster); (2) a transformational journey (the waiting game, loss of normalcy, strained relationships and mistrust, and financial challenges); and (3) the need for resources (day to day management, ages and stages, mental health supports, and "the dream"). CONCLUSION: An in-person allied health care team is needed to provide an integrated, patient-centered approach for how families can live and manage food allergies. Credible information and resources, such as medically reviewed websites, support groups, and counseling services, with a goal of reducing child and parental anxiety, should be provided by health care professionals.

Quantifying Human Innate Cytokine and Chemokine Responses Ex Vivo via Pattern Recognition Receptor Stimulation.

Linkages between human innate immune capacity, the environment in which we live, and the development of clinical tolerance versus a spectrum of disease phenotypes are a major focus of inflammatory disease research. While extensive epidemiologic evidence indicates key roles for the microbiome and other environmental factors, the underlying mechanisms that explain how these stimuli lead to a given clinical phenotype remain speculative. Here we review strategies for characterizing human cytokine production ex vivo in response to innate immune receptor stimulation with defined ligands. Human cytokine and chemokine biomarker data provides a tool to test hypotheses on the relationship between innate immune capacity in vivo and expression of current or future clinical phenotypes. The most important limitations of experimental strategies that have been used to date are reviewed. Detailed experimental protocols are provided for characterization of pattern recognition receptor (PRR)-driven stimulation with a panel of bacterial (TLR4, TLR5) and viral (TLR3, TLR7/8, RIG-I/MDA5) ligands to assess the role played by human pro-inflammatory, anti-inflammatory, Th1-like, and Th2-like responses. The importance of characterizing human innate immune phenotypes extends beyond discovery-based research to development of improved strategies for prevention or inhibition of chronic inflammatory diseases, improved design of immunization programs, and more effective cancer immunotherapy.

A qualitative study exploring parents' experiences with epinephrine use for their child's anaphylactic reaction.

BACKGROUND: Children with life threatening food allergies live with the constant threat of a fatal reaction, and caregivers must always be prepared to treat with an epinephrine auto-injector (EAI). This interpretive phenomenological study explored parents' perceptions and lived experiences with prescribed EAI use for their child. METHODS: The purposive sample included ten parents of five children under 12 years of age, diagnosed with a food allergy and prescribed with an EAI who recently experienced anaphylaxis. Data sources included digitally-recorded semi-structured interviews and a reflexive journal. RESULTS: Eight main themes emerged: perception of anaphylaxis, life challenges, isolation, anxiety, hesitation, guilt, influence of health care professionals, and lessons learned. Parents uniformly described multiple life challenges and feelings of isolation, anxiety and hesitation during a reaction that lead to subsequent guilt. CONCLUSIONS: Handling reactions correctly provided parents with confidence to treat subsequent reactions. Witnessing the effects of an EAI and receiving positive feedback from health care providers further strengthened their confidence to quickly and competently intervene in future reactions.

Wheeze trajectories are modifiable through early-life intervention and predict asthma in adolescence.

BACKGROUND: The objectives of this study were to identify developmental trajectories of wheezing using data-driven methodology, and to examine whether trajectory membership differentially impacts the effectiveness of primary preventive efforts that target modifiable asthma risk factors. METHODS: Secondary analysis of the Canadian Asthma Primary Prevention Study (CAPPS), a multifaceted prenatal intervention among children at high risk of asthma, followed from birth to 15 years. Wheezing trajectories were identified by latent class growth analysis. Predictors, intervention effects, and asthma diagnoses were examined between and within trajectory groups. RESULTS: Among 525 children, 3 wheeze trajectory groups were identified: Low-Progressive (365, 69%), Early-Transient (52, 10%), and Early-Persistent (108, 21%). The study intervention was associated with lower odds of Early-Transient and Early-Persistent wheezing (P < .01). Other predictors of wheeze trajectories included, maternal asthma, maternal education, city of residence, breastfeeding, household pets, infant sex and atopy at 12 months. The odds of an asthma diagnosis were three-fold to six-fold higher in the Early-Persistent vs Low-Progressive group at all follow-up assessments (P = .03), whereas Early-Transient wheezing (limited to the first year) was not associated with asthma. In the Early-Persistent group, the odds of wheezing were lower among intervention than control children (adjusted odds ratio: 0.67; 95% CI: 0.48; 0.93) at 7 years. CONCLUSIONS: Using data-driven methodology, children can be classified into clinically meaningful wheeze trajectory groups that appear to be programmed by modifiable and non-modifiable factors, and are useful for predicting asthma risk. Early-life interventions can alter some wheeze trajectories (ie, Early-Persistent) in infancy and reduce wheezing prevalence in mid-childhood.

Digital storytelling as a method in health research: a systematic review protocol.

BACKGROUND: Digital storytelling is an arts-based research method with potential to elucidate complex narratives in a compelling manner, increase participant engagement, and enhance the meaning of research findings. This method involves the creation of a 3- to 5-min video that integrates multimedia materials including photos, participant voices, drawings, and music. Given the significant potential of digital storytelling to meaningfully capture and share participants' lived experiences, a systematic review of its use in healthcare research is crucial to develop an in-depth understanding of how researchers have used this method, with an aim to refine and further inform future iterations of its use. METHODS: We aim to identify and synthesize evidence on the use, impact, and ethical considerations of using digital storytelling in health research. The review questions are as follows: (1) What is known about the purpose, definition, use (processes), and contexts of digital storytelling as part of the research process in health research? (2) What impact does digital storytelling have upon the research process, knowledge development, and healthcare practice? (3) What are the key ethical considerations when using digital storytelling within qualitative, quantitative, and mixed method research studies? Key databases and the grey literature will be searched from 1990 to the present for qualitative, quantitative, and mixed methods studies that utilized digital storytelling as part of the research process. Two independent reviewers will screen and critically appraise relevant articles with established quality appraisal tools. We will extract narrative data from all studies with a standardized data extraction form and conduct a thematic analysis of the data. To facilitate innovative dissemination through social media, we will develop a visual infographic and three digital stories to illustrate the review findings, as well as methodological and ethical implications. DISCUSSION: In collaboration with national and international experts in digital storytelling, we will synthesize key evidence about digital storytelling that is critical to the development of methodological and ethical expertise about arts-based research methods. We will also develop recommendations for incorporating digital storytelling in a meaningful and ethical manner into the research process. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registry number CRD42017068002 .

Reduced risk of peanut sensitization following exposure through breast-feeding and early peanut introduction.

BACKGROUND: Recent trials have shown that avoiding peanuts during infancy increases the risk of peanut allergy; however, these studies did not address maternal peanut consumption. OBJECTIVE: We sought to investigate the relationship between maternal peanut consumption while breast-feeding, timing of direct peanut introduction, and peanut sensitization at age 7 years. METHODS: Secondary analysis of a nested cohort within the 1995 Canadian Asthma Primary Prevention Study intervention study was performed. Breast-feeding and maternal and infant peanut consumption were captured by repeated questionnaires during infancy. Skin prick testing for peanut sensitization was performed at age 7 years. RESULTS: Overall, 58.2% of mothers consumed peanuts while breast-feeding and 22.5% directly introduced peanuts to their infant by 12 months. At 7 years, 9.4% of children were sensitized to peanuts. The lowest incidence (1.7%) was observed among children whose mothers consumed peanuts while breast-feeding and directly introduced peanuts before 12 months. Incidence was significantly higher (P < .05) if mothers consumed peanuts while breast-feeding but delayed introducing peanuts to their infant beyond 12 months (15.1%), or if mothers avoided peanuts themselves but directly introduced peanuts by 12 months (17.6%). Interaction analyses controlling for study group and maternal atopy confirmed that maternal peanut consumption while breast-feeding and infant peanut consumption by 12 months were protective in combination, whereas either exposure in isolation was associated with an increased risk of sensitization (P interaction = .003). CONCLUSIONS: In this secondary analysis, maternal peanut consumption while breast-feeding paired with direct introduction of peanuts in the first year of life was associated with the lowest risk of peanut sensitization, compared with all other combinations of maternal and infant peanut consumption.

In vivo immune signatures of healthy human pregnancy: Inherently inflammatory or anti-inflammatory?

Changes in maternal innate immunity during healthy human pregnancy are not well understood. Whether basal immune status in vivo is largely unaffected by pregnancy, is constitutively biased towards an inflammatory phenotype (transiently enhancing host defense) or exhibits anti-inflammatory bias (reducing potential responsiveness to the fetus) is unclear. Here, in a longitudinal study of healthy women who gave birth to healthy infants following uncomplicated pregnancies within the Canadian Healthy Infant Longitudinal Development (CHILD) cohort, we test the hypothesis that a progressively altered bias in resting innate immune status develops. Women were examined during pregnancy and again, one and/or three years postpartum. Most pro-inflammatory cytokine expression, including CCL2, CXCL10, IL-18 and TNFα, was reduced in vivo during pregnancy (20-57%, p<0.0001). Anti-inflammatory biomarkers (sTNF-RI, sTNF-RII, and IL-1Ra) were elevated by ~50-100% (p<0.0001). Systemic IL-10 levels were unaltered during vs. post-pregnancy. Kinetic studies demonstrate that while decreased pro-inflammatory biomarker expression (CCL2, CXCL10, IL-18, and TNFα) was constant, anti-inflammatory expression increased progressively with increasing gestational age (p<0.0001). We conclude that healthy resting maternal immune status is characterized by an increasingly pronounced bias towards a systemic anti-inflammatory innate phenotype during the last two trimesters of pregnancy. This is resolved by one year postpartum in the absence of repeat pregnancy. The findings provide enhanced understanding of immunological changes that occur in vivo during healthy human pregnancy.

Elevated antigen-driven IL-9 responses are prominent in peanut allergic humans.

Food allergies, and peanut allergy in particular, are leading causes of anaphylactic fatalities worldwide. The immune mechanisms that underlie food allergy remain ill-defined and controversial, in part because studies in humans typically focus on analysis of a limited number of prototypical Th1/Th2 cytokines. Here we determine the kinetics and prevalence of a broad panel of peanut-driven cytokine and chemokine responses in humans with current peanut allergy vs those with stable, naturally occurring clinical tolerance to peanut. Our primary focus is identification of novel indicators of immune dysregulation. Antigen-specific cytokine mRNA and protein responses were elicited in primary culture via peanut or irrelevant antigen (Leishmania extract, milk antigens) mediated stimulation of fresh peripheral blood cells from 40 individuals. Peanut extract exposure in vitro induced a broad panel of responses associated with Th2/Th9-like, Th1-like and Th17-like immunity. Peanut-dependent Type 2 cytokine responses were frequently found in both peanut allergic individuals and those who exhibit clinical tolerance to peanut ingestion. Among Th2/Th9-associated cytokines, IL-9 responses discriminated between allergic and clinically tolerant populations better than did commonly used IL-4, IL-5 or IL-13 responses. Comparison with responses evoked by unrelated control antigen-mediated stimulation showed that these differences are antigen-dependent and allergen-specific. Conversely, the intensity of IL-12, IL-17, IL-23 and IFN-γ production was indistinguishable in peanut allergic and peanut tolerant populations. In summary, the ability to generate and maintain cytokine responses to peanut is not inherently distinct between allergic and peanut tolerant humans. Quantitative differences in the intensity of cytokine production better reflects clinical phenotype, with optimally useful indicators being IL-9, IL-5, IL-13 and IL-4. Equivalent, and minimal, Ag-dependent pro-inflammatory cytokine levels in both healthy and peanut allergic volunteers argues against a key role for such cytokines in maintenance of clinical tolerance to food antigens in humans.

Are plasma IL-10 levels a useful marker of human clinical tolerance in peanut allergy?

BACKGROUND: Food allergies are a major component of the burden of allergic disease. Accurate risk assessment for prediction of future clinical reactivity or clinical tolerance is limited by currently available techniques. Recent studies suggest that constitutively elevated global serum levels of IL-10, a cytokine that down-regulates both Th1 and Th2 cytokine production, may be useful in identifying human clinical tolerance to foods. OBJECTIVE: Determine the usefulness of constitutive IL-10 levels as a marker of clinical tolerance to peanut in children and adults. METHODOLOGY/PRINCIPAL FINDINGS: 107 subjects who were clinically tolerant to peanut and 94 subjects who were clinically allergic to peanut participated. Plasma was analyzed via ELISA to quantify the frequency of individuals with constitutive IL-10 levels and the intensity of those responses. The data were then stratified by age, gender and clinical status to assess the utility of this putative biomarker in specific at-risk groups. All 201 subjects had readily quantified plasma IL-10. Levels were no higher in subjects who were clinically tolerant to peanut than those in individuals clinically allergic to peanut. Stratification by age, gender or both did not improve the capacity of IL-10 levels to identify clinical tolerance to peanut. CONCLUSIONS/SIGNIFICANCE: Plasma IL-10 levels are neither a useful biomarker of clinical tolerance to peanut nor a potential tool for identification of clinical tolerance to peanut in humans.