childhood nutrition

儿童营养
  • 文章类型: Journal Article
    食物恐惧症(FN)降低了营养充足性和多样性,这对儿童的健康和福祉构成了重大关注。我们描述了8岁儿童的FN得分,并在45个月时检查了其与营养相关行为的关联在新西兰成长队列中(n=4,621)。使用食物恐惧症量表(FNS)估计FN。使用独立样本的t检验和ANOVA比较变量类别之间的平均FNS得分。使用多元线性回归检查8年时的FNS评分与45个月时的营养相关行为之间的关联。平均(标准差)FN评分为46.2(15.2),性别差异具有统计学意义(男孩=47.6(15.7),女孩=43.8(14.2),p=<0.001)。对于所有的孩子,在根据母乳喂养持续时间和社会人口统计学特征调整的模型中:有时和从不/几乎从不与父母相同的食物的儿童,得分,平均而言,FNS高出5.8分和11分(与那些总是/几乎总是这样做的人相比);偶尔/从未发现用餐时间令人愉悦的儿童在FNS中平均得分低3.6分(与大多数/经常相比);在用餐时间总是/几乎总是开着电视的儿童在FNS中平均得分高2.7分(与从不/几乎从不)。与在进餐时间大部分/经常有时间与他人交谈的孩子相比,那些从未/偶尔做过的人在FNS总体上(高1.46分)和女孩中(高1.73分)的平均得分较高。这些发现支持国家儿童食品和营养指南中的饮食行为声明,强调早期接触食物多样性,限制进餐时间的分心,并承认父母的角色塑造塑造了儿童的营养相关行为。需要尽早采取预防性干预措施,以减少儿童早期和中期的FN。
    Food neophobia (FN) reduces nutritional adequacy and variety which poses a significant concern for children\'s health and well-being We described the FN scores among 8-year-olds and examined its associations with nutrition-related behaviors at 45 months within the Growing Up in New Zealand cohort (n = 4621). FN was estimated using the Food Neophobia Scale (FNS). Mean FNS scores between variable categories were compared using t-tests for independent samples and ANOVA. Associations between FNS scores at 8 years and nutrition-related behaviors at 45-months were examined using multivariate linear regression. The mean (standard deviation) FN score was 46.2 (15.2) with statistically significant differences by sex (boys = 47.6 (15.7), girls = 43.8 (14.2), p=<0.001). For all children, in models adjusted by breastfeeding duration and sociodemographic characteristics: children who sometimes and never/almost never ate the same foods as their parents, scored, on average, 5.8 and 11 points higher in the FNS (versus those who did always/almost always); children who occasionally/never found mealtimes enjoyable scored on average 3.6 points lower in the FNS (versus mostly/quite often); children who always/almost always had the television on during mealtimes scored on average 2.7 higher in the FNS (versus never/almost never). In comparison to children who mostly/quite often had time to talk to others during mealtimes, those who never/occasionally did it scored on average higher points in the FNS overall (1.46 points higher) and within girls (1.73 points higher). These findings support the eating behavior statements in the National Children\'s Food and Nutrition Guidelines, which emphasize early exposure to food variety, limiting mealtime distractions, and acknowledge that parental role modeling shapes children\'s nutrition-related behaviors. Early adoption of preventative interventions for reducing FN in early and middle childhood are needed.
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  • 文章类型: Journal Article
    背景:学校膳食计划对于减少儿童粮食不安全至关重要。这项研究确定了新奥尔良COVID-19期间分类特许学校系统中学校供餐服务的挑战和创新,路易斯安那州。
    方法:对学校官员和学校食品提供者进行了半结构化的定性关键线人访谈。采访被记录下来,转录,和编码。使用浸没结晶方法,模式被确定。
    结果:九位参与者描述了食品服务的挑战和解决方案/创新,重点围绕五个主题:食品服务,采购和成本,人员配备,沟通和外展,合作和伙伴关系。参与者在餐饮服务物流方面面临挑战,采购食品和用品,人员短缺,及时沟通,缺乏全市范围的协调,以及由于不断演变的大流行而需要迅速转移业务。虽然分类系统在全市范围的反应中带来了挑战,通过学校和社区之间的新伙伴关系和协调,分权制度以及政策变化为膳食计划提供了灵活性和创新的机会,食品服务和采购新流程的开发,和不同的沟通方式。
    结论:这些发现增加了对所面临的挑战和在分类学校系统中继续实施学校膳食计划的创新的理解。与社区组织合作,利用资源,协调沟通,和允许灵活性的政策是应对的关键,应鼓励在紧急情况下建设能力和复原力。在未来全市应急准备规划工作中,学校领导和食物提供者应纳入规划,以确保学生继续公平获得食物。
    BACKGROUND: School meal programs are critical to reducing childhood food insecurity. This study identified challenges and innovations in school meal service in a disaggregated charter school system during COVID-19 in New Orleans, Louisiana.
    METHODS: Semi-structured qualitative key informant interviews were conducted with school officials and school food providers. Interviews were recorded, transcribed, and coded. Using an immersion-crystallization approach, patterns were identified.
    RESULTS: Nine participants described challenges and solutions/innovations in food service focused around five themes: food service, procurement and costs, staffing, communication and outreach, and collaborations and partnerships. Participants faced challenges in meal service logistics, procuring food and supplies, staffing shortages, timely communication, lack of city-wide coordination, and the need to rapidly shift operations due to an evolving pandemic. While the disaggregated system created challenges in a city-wide response, the decentralized system along with policy changes offered opportunities for flexibility and innovation in meal programs through new partnership and coordination between schools and community, development of new processes for food service and procurement, and diverse modes of communication.
    CONCLUSIONS: These findings add to the understanding of challenges faced and innovations implemented to continue school meal programs in a disaggregated school system. Collaboration with community organizations, leveraging resources, coordinated communication, and policies allowing for flexibility were key to response and should be encouraged to build capacity and resiliency in emergencies. In future city-wide emergency preparedness planning efforts, school leaders and food providers should be included in the planning to ensure continued equitable food access for students.
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  • 文章类型: Journal Article
    目的:通过孕产妇健康素养检查儿童营养信息的来源和感知可信度。
    方法:经常使用社交媒体(N=340)的美国儿童(0-12岁)的母亲完成了一项在线调查。使用最新生命体征评估健康素养。使用逻辑和分位数回归模型,通过健康素养比较了儿童营养信息来源和来源的可信性。
    结果:17%的母亲健康素养有限。与具有足够健康知识的母亲相比,那些健康素养有限的人更有可能从兄弟姐妹那里获得儿童营养信息,大家庭,营养师,医生,执业护士,或者医生助理,和政府机构,并且不太可能从Facebook获取信息。健康素养有限的母亲对父母的信息进行评级,朋友,Facebook,和Instagram比具有足够健康知识的母亲更可信。虽然从医生那里感知到信息的可信度,执业护士,或者医生助理总体上很高,健康素养有限的母亲认为来自这些医疗保健提供者的信息不太可信.
    结论:儿童营养信息和感知可信度的来源因孕产妇健康素养而异。
    结论:鼓励儿科提供者向父母推荐提供循证儿童营养信息的资源。
    OBJECTIVE: To examine sources and perceived credibility of child nutrition information by maternal health literacy.
    METHODS: US mothers of children (0-12 years) who used social media regularly (N = 340) completed an online survey. Health literacy was assessed using the Newest Vital Sign. Child nutrition information sources and perceived credibility of sources were compared by health literacy using logistic and quantile regression models.
    RESULTS: Seventeen percent of mothers had limited health literacy. Compared to mothers with adequate health literacy, those with limited health literacy were more likely to get child nutrition information from siblings, extended family, dietitians, doctors, nurse practitioners, or physician assistants, and government agencies, and less likely to get information from Facebook. Mothers with limited health literacy rated information from parents, friends, Facebook, and Instagram as more credible than mothers with adequate health literacy. While perceived credibility of information from doctors, nurse practitioners, or physician assistants was high overall, mothers with limited health literacy perceived information from these health care providers as less credible.
    CONCLUSIONS: Sources of child nutrition information and perceived credibility differ by maternal health literacy.
    CONCLUSIONS: Pediatric providers are encouraged to refer parents to engaging resources that provide evidence-based child nutrition information.
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  • 文章类型: Journal Article
    在最初的1000天内食用软体动物和甲壳类动物可以通过提供必需的营养素来改善母婴健康。然而,在某些情况下,软体动物和甲壳类动物与过敏和环境污染有关,可能导致不良的健康和发展结果。目前尚不清楚食用软体动物和甲壳类动物是否对健康有益,在营养上统称为贝类,孕妇和儿童面临的潜在风险。我们在PubMed,Scopus,和EBSCO全球健康的文章发表在2000年1月至2022年3月之间,评估了怀孕期间贝类的消费量,哺乳期,或与孕产妇健康有关的童年(0-2岁),儿童健康,或儿童发展。本综述共包括46篇文章。总的来说,贝类消费与更高的环境污染物生物标志物相关,汞是研究最多的,证据基础最强。关于营养生物标志物状态的有限研究表明,贝类消费与碘状态之间存在关联。早产与食用贝类无关,但是新生儿人体测量结果好坏参半,几项研究报告出生体重较低,贝类消费量较高。少数检查儿童发育和孕产妇健康结果的研究报告没有显着关联。这项审查揭示了权衡健康风险和益处,将软体动物和甲壳类动物纳入母亲和幼儿的饮食模式。需要更多的研究来了解如何安全地食用这些水生动物源食品并利用它们来改善人类营养。
    Mollusc and crustacean consumption in the first 1000 d may improve maternal and child health by providing essential nutrients. However, in some contexts, molluscs and crustaceans have been associated with allergies and environmental contamination, potentially leading to adverse health and development outcomes. It is unclear whether the health benefits of consuming molluscs and crustaceans, collectively classified as shellfish in nutrition, are outweighed by the potential risks to pregnant women and children. We conducted a scoping review (PROSPERO: CRD42022320454) in PubMed, Scopus and EBSCO Global Health of articles published between January 2000 and March 2022 that assessed shellfish consumption during pregnancy, lactation or childhood (0-2 years) in relation to maternal health, child health or child development. A total of forty-six articles were included in this review. Overall, shellfish consumption was associated with higher biomarkers of environmental contaminants, with mercury being the most studied and having the strongest evidence base. The limited research on nutritional biomarker status shows an association between shellfish consumption and iodine status. Preterm birth was not associated with shellfish consumption, but newborn anthropometry showed mixed results, with several studies reporting lower birth weight with higher shellfish consumption. The few studies that examined child development and maternal health outcomes reported no significant associations. This review revealed trade-off health risks and benefits with inclusion of molluscs and crustaceans in the dietary patterns of mothers and young children. More research is needed to understand how these aquatic animal-source foods may be safely consumed and leveraged for improving human nutrition.
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  • 文章类型: Case Reports
    镰刀,由抗坏血酸(维生素C)缺乏引起的疾病,是现代世界的一种罕见疾病。我们报告了一个童年男孩的案例,有自闭症的背景,由于进行性双侧下肢疼痛而出现卧床,伴随皮疹,牙龈出血和嗜睡恶化。详细的饮食史显示饮食受到严格限制。体格检查显示双侧下肢瘀斑,卵泡周出血,毛囊周围角化过度和鸡头毛,这是镰刀的病理特征。低血清抗坏血酸水平证实了诊断。口服维生素C补充剂和多学科护理的康复治疗是成功的,症状完全解决。这个案例强调了对自闭症和食物选择性表现出非特异性症状的儿童进行全面饮食评估的重要性。医生对营养缺乏的认识避免了不必要的广泛调查和亚专科转诊,并转化为节省医疗费用。
    Scurvy, a disease caused by ascorbic acid (vitamin C) deficiency, is a rare disease in the modern world. We report a case of a boy in middle childhood, with a background of autism, presenting bed-bound due to progressive bilateral lower limb pain, with concomitant rashes, bleeding gums and worsening lethargy. Detailed dietary history revealed a severely restricted diet. Physical examination showed bilateral lower limb ecchymoses, perifollicular hemorrhages, perifollicular hyperkeratosis and cockscrew hairs which are pathognomonic features of scurvy. A low serum ascorbic acid level confirmed the diagnosis. Therapy with oral vitamin C supplement and rehabilitation with multidisciplinary care was successful, with complete resolution of symptoms. This case emphasises the importance of thorough dietary evaluation in children with autism and food selectivity presenting with non-specific symptoms. Physician awareness of nutritional deficiencies avoids unnecessary extensive investigations and sub-specialty referrals and translates to savings in medical expenses.
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  • 文章类型: Case Reports
    新生儿的牙齿萌出是一种罕见的口腔疾病,当它们在出生时出现时被称为“出生牙齿”,当它们在出生后的第一个月内萌出时被称为“新生儿牙齿”。在大多数情况下,它们是过早萌出的乳牙或多余的牙齿。应该给予支持性管理,为了方便孩子的喂养和防止进一步的并发症,比如牙齿可以移动的抽吸。这项研究描述了一系列报告给我们部门的案例,涉及出生时或出生后几天内位于下颌前区的牙齿。每个孩子的治疗选择都是基于对病例的个人评估,考虑监测和拔除以及相关并发症等选择。
    The eruption of teeth in newborns is a rare disorder of the oral cavity and are called \'natal teeth\' when they are present at birth or \'neonatal teeth\' when they erupt within the first month of life. In most of these cases, they are prematurely erupted deciduous teeth or supernumerary teeth. Supportive management should be given, to facilitate child\'s feeding and to prevent further complications, such as aspiration as the tooth could be mobile. This study describes a series of cases that were reported to our department, involving teeth located in the mandibular anterior region either at birth or within a few days after birth. The choice of treatment for each child was based on individual assessment of the case, considering options such as monitoring and extraction along with their associated complications.
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  • 文章类型: Journal Article
    食用高脂肪的零食和超加工食品(UPF),盐和糖(HFSS)与肥胖率上升和营养方面社会经济差距扩大有关。在婴儿期,童年和青春期是饮食偏好发展的关键时期,在这段时间里,探索支撑吃零食行为的因素的研究仍然缺乏。这篇综述旨在通过借鉴定性的生活经验研究来解决这一差距,拥有122个不同社会经济地位(SEP)的家庭,探索(I)家庭食物环境,(二)食物环境和(三)父母提供零食的社会价值和食物形状的含义。这篇综述表明,吃零食在日常生活中具有重要意义,婴儿从小就融入现有的零食习惯。价格促销,低成本和长保质期都使UPF和HFSS零食成为许多低SEP父母的吸引人的选择;而儿童对HFSS零食的要求和偏好在整个SEP中提出了挑战。然而,更高的SEP父母可以确保新鲜水果总是作为替代零食,而水果被描述为低SEP家庭的财务风险支出。目前的调查结果还表明,零售商和生产商越来越多地通过产品包装和营销来推广“更健康”的零食,例如\'每天满足您的五个中的一个\',尽管这些产品显示出与传统UPF和HFSS小吃相似的营养特征。我们提出了一系列政策建议,包括在学校扩大健康起步证和水果和蔬菜计划,并采取行动解决误导性的产品营销和包装。
    Consumption of snacks and ultra-processed foods (UPF) high in fat, salt and sugar (HFSS) is associated with rising rates of obesity and growing socioeconomic disparities in nutrition. While infancy, childhood and adolescence are critical periods for development of dietary preferences, there remains a dearth of research exploring factors that underpin snacking behaviour over this time. This review aims to address this gap by drawing from qualitative lived experience research, with 122 families of different socioeconomic position (SEP), to explore how the (i) home food environment, (ii) food environment and (iii) social value and meanings of food shape parental provision of snacks. This review shows that snacking holds important meanings in everyday family life, with infants integrated into existing snacking practices from an early age. Price promotions, low-cost and long shelf-lives all make UPF and HFSS snacks an appealing option for many low-SEP parents; while children\'s requests and preferences for HFSS snacks present a challenge across SEP. However, higher-SEP parents can ensure fresh fruits are always available as an alternative snack, while fruit is described as a financially risky expenditure for low-SEP families. The present findings also indicate that retailers and producers are increasingly promoting \'healthier\' snacks through product packaging and marketing, such as \'meets one of your five a day\', despite these products displaying similar nutritional profiles to traditional UPF and HFSS snacks. We outline a series of policy recommendations, including extending Healthy Start Vouchers and the Fruit and Vegetable Scheme in schools and action to address misleading product marketing and packaging.
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  • 文章类型: Journal Article
    目的:苯丙酮尿症(PKU)是一种遗传性代谢紊乱,其中苯丙氨酸(Phe)的积累导致神经学预后不良,而无需治疗。饮食疗法是主要的治疗方法,不依从性与血液Phe水平升高和相应的不良神经精神预后有关。这项研究旨在检查家庭访视对PKU患者血液Phe水平的影响。
    方法:65名接受低苯丙氨酸饮食的儿童PKU患者每月在家就诊,为期6个月。每次访问,提供了饮食教育,我们测量了患者的身高和体重,并收集了血液样本.
    结果:28例(43.1%)患者有典型PKU,37例(56.9%)有中度PKU。血液Phe水平起初有统计学意义的下降,第二,第五,与筛查访视的第六个月相比。与经典PKU患者不同,中度PKU患者的血液Phe水平在最后一次就诊时显着降低。在10岁以上的患者中观察到血液Phe水平显着降低。人体测量参数得到改善。
    结论:饮食依从性是PKU的主要治疗失败。家访教育是通过提供优质教育来改善治疗结果的一种有希望的方法,更好的评估,和纠正错误,但它们应该是持续的,并得到满足患者特殊需求的不同干预措施的支持。
    OBJECTIVE: Phenylketonuria (PKU) is an inherited metabolic disorder in which accumulation of phenylalanine (Phe) leads to poor neurological outcomes without treatment. Dietary therapy is the main treatment and nonadherence is associated with elevated blood Phe levels and correspondingly poor neuropsychiatric outcomes. This study aimed to examine the effect of home visits on blood Phe levels in PKU patients.
    METHODS: Sixty-five paediatric PKU patients who were on low-phenylalanine diet were visited monthly at home for 6 months. At each visit, dietary education was provided, patients\' height and weight were measured and blood samples were collected.
    RESULTS: Twenty-eight (43.1%) patients had classic PKU and 37 (56.9%) had moderate PKU. Blood Phe levels decreased statistically significant at first, second, fifth, and sixth months compared with screening visit. Blood Phe levels in moderate PKU patients decreased significantly at the last visit unlike classic PKU patients. A significant decrease in blood Phe levels was observed in patients older than 10 years. Anthropometric parameters improved.
    CONCLUSIONS: Dietary nonadherence is the main treatment failure in PKU. Home visits for education are a promising way to improve treatment outcomes by providing quality education, better assessment, and correction of mistakes but they should be ongoing and supported by different interventions that address patients\' special needs.
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  • 文章类型: Journal Article
    目的:不健康的食品和饮料在新西兰学校食堂中广泛可用。这项研究的目的是根据新实施的卫生部“学校饮食指导”评估小学食堂的食物菜单。
    方法:在2020年收集了133个小学食堂菜单的便利样本,作为整个新西兰健康主动学习计划基线评估的一部分。根据卫生部的“学校食品和饮料指南”,开发了一个菜单分析工具包来评估菜单,该指南将食品分为三类:“绿色”,\'琥珀色\'和\'红色\'。
    结果:大多数菜单项属于不太健康的琥珀色(41.0%)和红色(40%)食品类别。与高十分位学校相比,低十分位学校的绿色食品比例较低(8.6%),红色食品比例较高(48.3%)。三明治,填充卷和包装是最常见的物品,其次是烘焙食品和糕点食品。超过一半的内部食堂菜单项被归类为“红色”食品(55.3%)。
    结论:大多数学校食堂不符合卫生部规定的健康食品和饮料供应指南。需要优先改善社会经济贫困地区儿童的食物环境,以减少不平等。这项研究强调了新西兰学校不健康的食物环境,并强调需要更强有力的国家政策和强制性的学校指导。
    OBJECTIVE: Unhealthy food and drinks are widely available in New Zealand school canteens. The aim of this study was to assess primary school canteen food menus against the newly implemented Ministry of Health \'Food and Drink Guidance for Schools\'.
    METHODS: A convenience sample of 133 primary school canteen menus was collected in 2020 as part of the baseline evaluation of the Healthy Active Learning initiative across New Zealand. A menu analysis toolkit was developed to assess menus in accordance with the Ministry of Health\'s \'Food and Drink Guidance for Schools\' which classifies food items into three food categories: \'green\', \'amber\' and \'red\'.
    RESULTS: Most menu items belonged to the less healthy amber (41.0%) and red (40%) food categories. Low decile schools had a lower percentage of green food items (8.6%) and a higher percentage of red food items (48.3%) compared to high decile schools. Sandwiches, filled rolls and wraps were the most commonly available items, followed by baked foods and foods with pastry. Over half of the in-house canteen menu items were classified as \'red\' foods (55.3%).
    CONCLUSIONS: Most school canteens were not meeting the guidelines for healthy food and drink provision outlined by the Ministry of Health. Improving the food environment for children in socio-economically deprived areas needs to be prioritised to reduce inequities. SO WHAT?: This study highlights the unhealthy food environments in New Zealand schools and emphasises the need for more robust national policies and mandated school guidance.
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  • 文章类型: Randomized Controlled Trial
    背景:以前,与标准RUTF(s-RUTF)相比,新型燕麦即食治疗性食品(o-RUTF)可改善严重急性营养不良(SAM)的恢复情况.o-RUTF含有18%的燕麦,而s-RUTF没有谷物成分。
    目的:我们确定了o-RUTF对肠道通透性的影响,通过乳果糖渗透率测量,和SAM患儿的16S核糖体RNA(rRNA)粪便微生物组构型。
    方法:这是一个前瞻性的,随机化,双盲,对照临床试验。6-59个月的塞拉利昂儿童与SAM,由一个midupper臂周长<11.5厘米,随机接受o-RUTF或s-RUTF。所有儿童根据指南接受7d阿莫西林治疗。在基线和治疗4周后进行乳果糖通透性测试和粪便16SrRNA测序。乳果糖渗透性的变化是主要结果,而4周时的粪便16SrRNA构型是次要结局。
    结果:在129名儿童中,乳果糖渗透率测试在基线时完成100,在第4周完成82。经过4周的治疗性喂养,o-RUTF组和s-RUTF组之间乳果糖渗透率无差异(P=0.84),超过一半的儿童乳果糖渗透性增加(50%s-RUTF与58%o-RUTF相比,平均差=-7.5%;95%CI:-29.2,15.2;P=0.50)。喂食4周后,o-RUTF和s-RUTF组之间的16SrRNA构型没有差异(Permanova,999个排列;P=0.648;伪F=0.581),α或β多样性也没有差异。
    结论:尽管o-RUTF和s-RUTF的组成明显不同,在接受这些食物的SAM患儿中,乳果糖通透性或粪便16SrRNA构型没有发现差异.这些结果表明,o-RUTF通过除了降低肠渗透性或改变粪便16S构型之外的机制发挥其有益作用。该试验在clinicaltrials.gov注册为NCT04334538。
    Previously, a novel oat ready-to-use therapeutic food (o-RUTF) resulted in improved recovery from severe acute malnutrition (SAM) when compared to a standard RUTF (s-RUTF). The o-RUTF contained 18% oat, while the s-RUTF has no cereal ingredients.
    We determined the effects of o-RUTF on intestinal permeability, as measured by lactulose permeability, and the 16S ribosomal RNA (rRNA) fecal microbiome configuration of children with SAM.
    This was a prospective, randomized, double-blinded, controlled clinical trial. Sierra Leonean children aged 6-59 mo with SAM, defined by a midupper arm circumference < 11.5 cm, were randomized to receive o-RUTF or s-RUTF. All children received 7 d of amoxicillin per guidelines. Lactulose permeability testing and fecal 16S rRNA sequencing were performed at baseline and after 4 wk of therapy. The change in lactulose permeability was the primary outcome, while the fecal 16S rRNA configuration at 4 wk was a secondary outcome.
    Of the 129 children enrolled, lactulose permeability testing was completed by 100 at baseline and 82 at week 4. After 4 wk of therapeutic feeding, there were no differences in lactulose permeability between the o-RUTF and s-RUTF groups (P = 0.84), and over half of children had increased lactulose permeability (50% s-RUTF compared with 58% o-RUTF, mean difference = -7.5%; 95% CI: -29.2, 15.2; P = 0.50). After 4 wk of feeding, there were no differences in the 16S rRNA configurations between the o-RUTF and s-RUTF groups (Permanova, 999 permutations; P = 0.648; pseudo-F = 0.581), nor were there differences in α or β diversity.
    Despite remarkably different compositions of o-RUTF and s-RUTF, no differences were identified in lactulose permeability or the fecal 16S rRNA configuration among children with SAM receiving these foods. These results suggest that the o-RUTF exerts its beneficial effects through mechanisms other than reducing intestinal permeability or altering the fecal 16S configuration. This trial was registered at clinicaltrials.gov as NCT04334538.
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