Feeding Nutrition Research Articles

Reducing Procedural Pain and Avoiding Peripheral Intravenous Catheters by Implementing a Feeding Protocol for Late Preterm Infants: A Quality Improvement Project.

Late preterm births account for a large portion of preterm births, yet the optimal method of nutrition and enteral feeding in this population remains unclear and often involves intravenous (IV) fluids. To develop and implement a late preterm feeding protocol in order to decrease the necessity of IV access, decrease the use of starter parenteral nutrition (PN), and reduce the pain endured by an infant in the neonatal intensive care unit. The Plan-Do-Study-Act quality improvement model was utilized as a framework for the implementation of this quality improvement project. A literature review was conducted and subsequently, a feeding protocol was developed and included the more judicious use of starter PN. This protocol was implemented, evaluated, and adopted. A second Plan-Do-Study-Act cycle was completed with the addition of an auto-text reminder incorporated into admission notes in the electronic medical record. The implementation of the protocol significantly reduced placement of IV access and the use of starter (PN) in late preterm infants without considerable differences in balancing measures. The percentage of infants who received peripheral IV access declined considerably from 70% to 42% ( P = .0017) subsequently, less pain endured by the infants. There was a decrease in the initiation of starter PN from 55% to 7% ( P < .00001). Administering enteral feedings on admission to stable, late preterm infants reduced the need for peripheral IV access and thus decreased pain from this procedure.

Awareness of Safe Feeding Practices among Expecting and New Indian Mothers: A Survey

The government of India has been conducting focused programs for ensuring child and maternal nutrition, health, and well-being. A major mission in this regard is creating public awareness of importance of adequate nutrition from early on. Medical professionals have also compiled scientific recommendations that guide parents toward the timelines and type of foods to be fed in the first 24 months. However, from various research publications, child mortality rate secondary to pneumonia and obesity continues to be a major concern in India. One possible reason could be the actual household feeding practices. This study aimed to verify the understanding of pediatric feeding guidelines among expectant and new Indian mothers. Two close-ended multiple-choice questionnaires were developed and validated for expecting and new mothers. Responses were obtained from 100 participants through social media platforms using snowball paradigm. Response analysis revealed that understanding of breastfeeding guidelines was better compared to complementary feeding. While timeline-related questions received more accurate responses, most participants responded inaccurately towards safety and strategy-related information. Perceptions on feeding methods were different across the two participant groups. Developmentally normal behaviors such as gagging were considered as problem behavior by both groups. Interestingly, safety concerns were better identified by expecting mothers than new mothers. The results implied that public awareness programs need to broaden the focus from breastfeeding to include methods, strategies, and safety of complementary feeding for adequate nutrition and health. The guidelines developed in this regard need to be effectively communicated to the public for better impact on social health.

Adverse Metabolic Phenotypes in Parenterally Fed Neonatal Pigs Do Not Persist into Adolescence

BackgroundNutrition during fetal and neonatal life is an important determinant for the risk of adult-onset diseases, especially type 2 diabetes and obesity. ObjectivesWe aimed to determine whether total parenteral nutrition (TPN) compared with enteral formula feeding [enteral nutrition (EN)] in term piglets during the first 2 wk after birth would increase the long-term (5-mo) development of metabolic syndrome phenotypes with adverse glucose homeostasis, fatty liver disease, and obesity. MethodsNeonatal female pigs were administered TPN (n = 12) or fed enterally with a liquid enteral milk-replacer formula (EN, n = 12) for 14 d. After transitioning TPN pigs to enteral feeding of liquid formula (days 15–26), both groups were adapted to a solid high-fat diet (30% of the total diet) and sucrose (20% of the total diet) diet (days 27–33), which was fed until the end of the study (140 d). Body composition was measured by dual-energy X-ray absorptiometry at 14, 45, and 140 d. Serum biochemistry and glucose-insulin values (after a fasting intravenous glucose tolerance test) were obtained at 140 d. Liver and muscle were analyzed for insulin receptor signaling and triglycerides. ResultsBody weight was similar, but percent fat was higher, whereas percent lean and bone mineral density were lower in TPN than in EN pigs (P < 0.01) at 45 d of age but not at 140 d. At 140 d, there were no differences in serum markers of liver injury or lipidemia. Intravenous glucose tolerance test at 140 d showed a lower (P < 0.05) AUC for both glucose and insulin in TPN than in EN pigs, but the ratio of AUCs of insulin and glucose was not different between groups. ConclusionsAdministration of TPN during the neonatal period increased adipose deposition that transiently persisted in early adolescence when challenged with a high-fat diet but was not sustained or manifested as glucose intolerance.

Fathers Nutrition Knowledge and Child Feeding Practices Associated with Childhood Overweight and Obesity: A Scoping Review of Literature From 2000 to 2023.

Objective. Childhood overweight/obesity is a serious global public health issue, demanding parental involvement to reverse trends. Despite fathers' crucial parenting roles, research on fathers and childhood overweight/obesity is limited. This scoping review examines the literature on fathers' nutrition knowledge and feeding practices with childhood overweight/obesity. Methods. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and Arksey and O'Malley (2005) framework, multiple databases were searched. Eligible father-child related studies focused on fathers' nutrition knowledge, feeding practices, and childhood overweight/obesity. Results. Of 26 eligible articles, 52% originated from the United States, and 44% focused on father-child dyads. Most studies were cross-sectional (64%) and survey-based (68%). Further, 11.5% assessed fathers' nutrition knowledge, and child feeding practices (53.4%). Conclusion. Literature on fathers' nutrition knowledge and feeding practices concerning childhood overweight/obesity is limited. Scaling-up fathers' inclusion in childhood nutrition research is encouraged for the design of holistic interventions.

Formulation High Energy and Rich Iron of Granola Snackbar as a Nutritional Supplementary Feeding to Prevent Malnutrition in Pregnant Women

Background: Providing supplementary feeding from local food is one strategy to address the nutritional problems of pregnant women in Indonesia. Improper eating habits of pregnant women are one of the causes of nutritional disorders, one of which is anemia and chronic lack of energy. The aim of this research was to develop and evaluate high-energy and rich-iron granola snackbars as a nutritional supplementary feeding to prevent malnutrition in pregnant women. Granola snackbars (formulas P1, P2, P3, and P4) were prepared using the same ratios of seaweed, moringa leaves, beetroot oats, nuts (peanuts, walnuts, and almonds), cornstarch, peanut butter, fish oil, salt, sugar, and water, in addition to chicken liver formulation and snakehead fish (P1: 0 gr, 75 gr), (P2: 10 gr, 65 gr), (P3: 20 gr, 55 gr), and (P4: 30 gr, 45 gr). Methods: The method employed a fully randomized design in a pure experimental setting. Proximate testing involved determining the snackbars' color, texture, taste, and aroma, as well as their energy, protein, fat, carbohydrate, and Fe contents. Organoleptic testing covered these aspects as well. Results: Formula P2 had the highest energy (521.01 kcal), and Formula P4 had the highest Fe value at 4.34%. The organoleptic test showed that the most preferred formulation was the formulation with a proportion of Formula P2. Conclusion: This study recommends using Formula P2 as a source of energy to prevent malnutrition in pregnant women and Formula P4, which has a high iron content, to improve the hemoglobin level in pregnant women.

Feeding Behaviour and Nutritional Status among Children Aged 6 to 23 Months Old in Bahi District in Tanzania.

The survival, well-being, and development of young children depend on optimal infant and young child feeding (IYCF) practices. It is imperative to assess nutrition status and feeding behaviour practices in order to develop interventions. The objective of this study is to assess nutrition status, feeding behaviour, and its association with nutrition status among children aged 6 to 23 months old in Bahi district, Tanzania. A community-based, cross-sectional study was employed. A multistage sampling technique was used. Bahi district council, wards, and village were randomly selected, and then a systematic random sampling method was used to select participants. Anthropometric measurements were used to determine the nutrition status of children. Process for the Promotion of Child Feeding (ProPAN) manual guided assessment of feeding behaviours associated with nutrition status. Z-score was used to determine the level of malnutrition; the chi-square test and logistic regression were used as descriptive and inferential statistical tests, respectively, to determine the association between nutrition status and feeding behaviour. Out of 395 children aged between 6 and 23 months, 62.8% were stunted, 25.3% were underweight, and 6.6% were wasted. In the multivariable analysis, the results reveal that stunting was significantly associated with perception of exclusive breastfeeding (number of months) (AOR 4.24, 95%CI: 2.012-8.284) and number of feeds per day (AOR 2.02, 95%CI: 1.00-6.314). With regard to perception of exclusive breastfeeding (number of months), the children whose mothers perceived that children supposed to be breastfed for more than six months were four times more likely to be not stunted compared to those who were perceived to be breastfed less than three months, and the children whose mothers' fed them twice to three times were two times more likely to be not stunted compared to the children who were fed only two times. Bahi district council has a higher prevalence rate of stunting, underweight, and wasting among children aged 6 to 23 months. Feeding on the first colostrum, exclusive breastfeeding, and breastfeeding for more than six months are the main determinants of nutrition status.

Factors affecting the quality and nutritional value of donkey meat: a comprehensive review.

Donkey meat is characterized by a high content of proteins, essential amino acids, and unsaturated fatty acids and is low in fat, cholesterol, and calories. Thus, it is considered a high-quality source of meat. Based on the data from PubMed and Web of science within past 10 years, this review summarizes the factors affecting the quality of donkey meat and its nutritional value, including breed, genetics, gender, age, muscle type, feeding regimen, storage and processing conditions. Breed, gender, age, and feeding regimen mainly affect the quality of donkey meat by influencing its intramuscular fat content and carcass quality. Meanwhile, the tenderness and flavor of donkey meat depend on the muscle type, storage and processing conditions. Genetics, on the other hand, fundamentally affect donkey meat quality by influencing the polymorphism of genes. These findings provide valuable insights and guidance for producers, consumers, and decision-makers in the donkey meat industry, promoting the development of more effective marketing strategies and the improvement of meat quality, thereby enabling the expansion and progress of the entire industry.

Dietary supplementation of Moringa leaf powder improves the productive and reproductive performance of Pekin duck

Duck production is often considered advantageous compared to other poultry species due to its lower care and management requirements. However, intensive duck farming necessitates balanced nutrition and additional feed supplements to achieve optimal profitability. In addition to high-quality proteins, vitamins, and minerals, Moringa leaves are rich in various bioactive compounds, and their dietary supplementation is proven to improve the production and reproduction performances of animals and birds. The present study was conducted to reveal the effect of Moringa leaf powder (MLP) in duck ration. The experiment was conducted with different percentages of MLP (0%, 2%, 4% and 6%) supplemented to basal ration of Pekin duck. It was observed that supplementing duck feed with 4% MLP is optimal for improving production and reproduction parameters. This supplementation boosts mature body weight and live weight gain by lowering the feed conversion ratio (FCR), increasing dressing percentage, and decreasing triglycerides and cholesterol levels in blood lipids without negatively affecting other blood parameters. Most importantly, the ducks fed with 4% MLP-supplemented diet reached sexual maturity 7-10 days earlier than other MLP-treated or control groups. Moreover, MLP supplementation enhances the fertility and hatchability of ducks. Notably, the semen volume and sperm quality parameters, including sperm total motility, progressive motility, viability and concentration with reduced sperm abnormality in drakes fed with 4% MLP compared to other MLP-treated and control groups. Therefore, it can be suggested that 4% MLP can be used in duck ration to enhance the productive and reproductive profile of ducks.

重症患者肠内营养喂养不耐受的中医治疗

重症患者肠内营养喂养不耐受的中医治疗

Constraints of Workload in Agricultural Food Production on Children Nutritional Status, Feeding and Hygiene Practices among Rural Women in Ibadan, Nigeria

Constraints of Workload in Agricultural Food Production on Children Nutritional Status, Feeding and Hygiene Practices among Rural Women in Ibadan, Nigeria

Dietary Pattern and Its Impact on Nutritional Status of Adolescent Girls among Chepang Community in Raksirang Rural-Municipality of Makawanpur District

Background: Adolescence is a period of transition between childhood and adulthood. An adolescent is defined as individuals in the 10-19year age group. The health and nutritional status of adolescent girls affects their health and their survival in future. Adolescents, particularly girls, are increasingly conscious of their body which leads to low intake of food rich with nutrients. Teenage girls may excessively restrict their energy intake, out of a desire to be thin, which has a serious threat on their nutritional status.Methods: Descriptive cross sectional study design was applied in ward number 5 of Raksirangrural municipality of Makawanpur district usingsemi-structured questionnaire and all adolescent girls (127) of aged 10-19 years were involved as the respondents of the study. The study duration was 7th June to 25th December 2017. The data was entered and analyzed with the help of software SPSS version 16.0. Results: The prevalence of underweight was found to be 27.6%. Study shows the participants consume protective fruits and vegetables group and other fruits and vegetables group in less quantity as comparison to other food groups. Though most of the participants were literate, knowledge on nutrition about 8% had adequate knowledge and 91% had poor knowledge.Conclusions: Nutritional status of adolescent girls of Raksirangrural municipality is found to be poor. The research recommends improving nutritional status and feeding habits especially intake of wheat, meat and yellow fruits focusing on adolescent girls.

Substandard feeding in children undergoing mechanical ventilation in pediatric intensive care unit: A retrospective cohort study in China.

Enteral nutrition is a common yet vital practice in the pediatric intensive care unit (PICU). However, the status of substandard feeding of enteral nutrition in PICU children undergoing mechanical ventilation remains unclear and can be detrimental to the children's prognosis. This study aimed to evaluate the incidence, nursing care status, and influencing factors of substandard feeding in children undergoing mechanical ventilation in the PICU. This study employed a retrospective cohort design. Children undergoing mechanical ventilation and enteral nutrition in the PICU of a public hospital in China from 1 June 2021 to 31 December 2022 were selected using convenience sampling, and their characteristics were collected and evaluated. Pearson correlation analysis and multivariate logistic regression analysis were conducted to assess the influencing factors of substandard feeding in PICU children with mechanical ventilation. A total of 156 PICU children undergoing mechanical ventilation were included for analysis in this study. The rate of substandard feeding in PICU children was 65.38%. Statistically significant differences were observed in diarrhea, vomiting, the use of sedatives, and average infusion speed between the substandard feeding group and the standard group (p <0.05). Pearson correlation results indicated that diarrhea (r = 0.595), vomiting (r = 0.602), and average infusion speed (r = 0.562) were correlated with substandard feeding and characteristics of included ICU children undergoing mechanical ventilation (p <0.05). Logistic regression results found that diarrhea (OR = 2.183, 95%CI: 1.855~2.742), vomiting (OR = 3.021, 95%CI: 2.256~4.294), and average infusion speed ≤40 mL/h (OR = 2.605, 95%CI: 1.921~3.357) were independent risk factors for substandard feeding in mechanically ventilated children in the ICU (p <0.05). The rate of substandard feeding in children with mechanical ventilation in the PICU was high. Diarrhea, vomiting, and slow infusion speed are important influencing factors for substandard feeding. It is suggested that nurses and other healthcare professionals take targeted measures, including the prevention and care of diarrhea and vomiting, as well as monitoring and adjusting the infusion speed of enteral nutrition, to reduce the occurrence of substandard feeding.

Social predictors of breastfeeding and the impact of interventions on breastfeeding of preterm infants: A longitudinal study.

The multifaceted benefits of breastfeeding for mothers and infants include enhanced neurodevelopment and immune function in preterm infants. However, more research is needed to understand the unique factors affecting breastfeeding practices in preterm infants. This study aimed to identify key social predictors of breastfeeding in preterm infants and assess the effectiveness of specific interventions on their feeding practices during the first six months postpartum. A prospective, monocentric, longitudinal study involving a cohort of 201 preterm infants was executed at the Neonatology Department, Ceske Budejovice Hospital, Czech Republic, from January 2020 to January 2023. The STROBE guidelines were used. The study results elucidated a transition from breastfeeding to bottle feeding and formula within the infants' first six months. Notable social predictors of breastfeeding encompassed factors such as the number of children in the household, the mother's marital status, and the nature of housing. Certain interventions, including immediate skin-to-skin contact between mother and child, and initiation of nutritive feeding within the first half-hour post-birth, significantly influenced the probability of breastfeeding. The data underscored that social predictors and nursing interventions substantially shape the breastfeeding practices of preterm infants during the first six months postpartum. Inequities in health outcomes among premature infants can be effectively curbed through comprehensive care models that account for socioeconomic factors influencing breastfeeding.

Signaling in Legume-Rhizobia Symbiosis.

Legumes represent an important source of food protein for human nutrition and animal feed. Therefore, sustainable production of legume crops is an issue of global importance. It is well-known that legume-rhizobia symbiosis allows an increase in the productivity and resilience of legume crops. The efficiency of this mutualistic association strongly depends on precise regulation of the complex interactions between plant and rhizobia. Their molecular dialogue represents a complex multi-staged process, each step of which is critically important for the overall success of the symbiosis. In particular, understanding the details of the molecular mechanisms behind the nodule formation and functioning might give access to new legume cultivars with improved crop productivity. Therefore, here we provide a comprehensive literature overview on the dynamics of the signaling network underlying the development of the legume-rhizobia symbiosis. Thereby, we pay special attention to the new findings in the field, as well as the principal directions of the current and prospective research. For this, here we comprehensively address the principal signaling events involved in the nodule inception, development, functioning, and senescence.

Assessment of the feed additive consisting of zinc chloride hydroxide monohydrate for all animal species for the renewal of its authorisation (NUTRECO Nederland B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of zinc chloride hydroxide monohydrate as a nutritional feed additive for all animal species (3b609). The applicant reported changes in the production process and requested a change in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of the additive under the current authorised conditions of use is safe for the target species and the consumers. The use of the additive in animal nutrition at the proposed use levels for the terrestrial species and land-based aquaculture systems is considered safe for the environment. The FEEDAP Panel cannot conclude on the safety of the additive for marine sediment compartment, when it is used in sea cages. The additive is an eye irritant, but not irritant to the skin and not a skin sensitiser. The exposure through inhalation is likely, but in the absence of data, the Panel is not in a position to conclude on the risk of exposure by inhalation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Modification of the terms of authorisation of zinc-l-selenomethionine as a feed additive for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a new preparation of zinc-l-selenomethionine, with selenium content of 4%, as a nutritional feed additive for all animal species. Zinc-l-selenomethionine is already authorised for use in all animal species (3b818). Current authorisation defines the additive as 'Solid preparation of zinc-l-selenomethionine with a selenium content of 1-2 g/kg'. The applicant developed a new preparation of zinc-l-selenomethionine containing a minimum of 40 g Se/kg and seeks to modify the current authorisation. The FEEDAP Panel concluded that the newly proposed preparation is considered safe for all animal species. The FEEDAP Panel recommends adding, to the currently existing authorisation, a new preparation (40-46 g Se/kg) and not the range proposed by the applicant (1-46 g Se/kg), since no characterisation data on the intermediate preparation range (from 2 to 40 g Se/kg) have been provided. The use of the new preparation (minimum 40 g Se/kg) of zinc-l-selenomethionine in animal nutrition is of no concern for consumer safety. The newly proposed preparation presents a risk by inhalation; it is not irritant to eyes or skin. No conclusion can be reached regarding dermal sensitisation. The previous conclusion by the Panel on the safety for the environment remains unchanged. The Panel concluded that the modification request has no impact on efficacy.

The Effect of Probiotics to Betta Fish (Betta splendens Regan, 1910) Aquaculture Performance

Betta fish (Betta splendens) is one type of ornamental fish that has high economic value. However, one of the obstacles on its cultivation activity is poor nutrition feed that support the enlargement process. One of the solution is adding probiotics. Probiotics can optimize fish growth, including betta fish. This study aimed to determined the best dose of the probiotics to increased the growth performance of betta fish. This study used a completely randomized design with 4 treatments and 3 replications (C: control, A: 5 ml/kg of feed, B: 7 ml/kg of feed, and C: 9 ml/kg of feed). The data was analyzed by Anova and Duncan’s test. Based on the parameters observed, it was shown that the addition of probiotics in commercial feed in treatment C (9 ml/kg feed) had a significant effect on the growth of absolute weight, SGR, and FCR.

Assessment of the feed additive consisting of folic acid for all animal species for the renewal of its authorisation (Chr. Olesen A/S and DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of folic acid as a nutritional feed additive. The additive is authorised for use in feed and water for drinking for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the safety for the terrestrial species, consumers and for the environment. The use of folic acid in aquatic animal species to cover their nutritional needs is considered safe. However, the Panel is not in a position to set a maximum safe level for all fish and crustacean species. Considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, the FEEDAP Panel considers that supplementation should not exceed the requirements of the different aquatic animal species. The additive is neither a skin irritant nor a dermal sensitiser. The exposure through inhalation is likely. Due to the lack of data, the FEEDAP Panel is not in the position to conclude on the potential of folic acid to be harmful to the respiratory system and irritant to eyes. The Panel retains that the previously made conclusion on the efficacy remains valid.

Factors associated with food consumption and dietary diversity among infants aged 6-18 months in Ashanti Region, Ghana.

Studies have reported a poor diet quality among children in Ghana and other developing countries. Inadequate dietary diversity among children may lead to deficiencies in micronutrient intake necessary for growth and other cognitive functions. Understanding factors associated with infants' diverse diets is a key step to promoting adequate infant and young child nutrition. This study sought to determine the factors associated with food consumption and dietary diversity (DD) among infants. In this cross-sectional study among 1503 mothers-infant (aged 6-18 months) pairs from rural, urban, and peri-urban districts of Ashanti Region, factors associated with food consumption and DD were evaluated. The FAO 18-food group DD questionnaire was used to determine previous food group intake, while a structured questionnaire was used to capture data on the mother's socio-demographic parameters and child morbidity. Data were analyzed using descriptive statistics, the Chi-square test, and binary logistic regression to compare mothers and infants who had adequate and inadequate DDS of 9 out of 18 food groups and the predictors of dietary diversity. About 64.7% of the infants did not meet the minimum dietary diversity. Over two-third (77.4%) of the children consumed maize porridge the previous day. Foods which were less consumed included vegetables (35%), animal milk (38.9%), and meat (organ 14%, any meat 26%). The mean food group intake from 18 food groups was 7.0, and the majority (64.7%) did not meet the recommended 9 food group intake. Significantly more younger children (6-11 months) (74%, p<0.001) compared with older children (12-18 months) (52.5%) did not meet the minimum DDS. Also compared with the older children, the younger ones had above two times increased odds of inadequate DD (OR = 2.5, p<0.001, 95% CI = 1.4-4.4). When controlled for gender, children from peri-urban areas (OR = 5.2, p = 0.260, 95% CI = 0.2-93.2) and rural areas (OR = 1.8, p = 0.650, 95% CI = 0.2-9.3) had increased odds of lower DD than urban children. Children of unemployed caregivers had an increased odds of low DD (OR = 2.3 p<0.001, 95% CI 1.7-3.2) compared with children of employed caregivers. Finally, children of caregivers with better nutrition knowledge (nine correct answers from 12 questions) had lower odds of having lower dietary diversity (adjusted OR = 0.9, p = 0.85, 95%CI = 0.5-1.6) than those with less knowledge. Low DD was common among infants and associated with infants age, caregivers' areas of residence, employment status, and level of nutrition education. Children who did not meet the minimum dietary diversity were not fed particular foods such as vegetables, animal milk, and organ meat. Proper maternal nutrition education and feeding practices targeting age-specific needs and community livelihood support systems are necessary to improve dietary diversity of infants.

Evaluation of the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT

Background: Oral mucositis (OM) is one of the most prevalent complications leading to severe pain, difficulty eating, prolonged hospitalization, and life-threatening septic condition in patients receiving chemotherapy containing conditioning regimen prior to autologous hematopoietic stem cell transplantation (auto-HSCT). MIT-001 is a novel small molecule functioning as a mitochondria-targeted radical trapping agent (RTA) that effectively inhibits cellular ferroptosis/necrosis and cytokine production via blockade of reactive oxygen species (ROS) generation and calcium accumulation in the mitochondria. The current clinical study was designed to evaluate the safety, efficacy by prevention of OM and pharmacokinetics of MIT-001 in patients with lymphoma or multiple myeloma (MM) undergoing chemotherapy prior to auto-HSCT. Methods: This phase IIa study consists of two parts: part 1 is an open label dose-escalating study dosing from 5 mg, 10 mg and up to 20 mg of MIT-001 to determine the recommended Part 2 Dose (RP2D) via evaluating the efficacy of OM, safety and pharmacokinetic characteristics of MIT-001, whereas Part 2 is a placebo-controlled, double-blinded, and randomized study to find the optimal dose of MIT-001 regarding the efficacy of OM and safety for the next IIb/III clinical trials. In Part 1, the total screening period was 28 days: conditioning chemotherapy/MIT-001 treatment for four to nine days followed by auto-HSCT and recovery for 14 days and discharge at 28 days following HSCT. MIT-001 was administered intravenously for 30 minutes once daily before conditioning chemotherapy for four to nine days, depending on the conditioning regimens including high-dose melphalan and BMT (intravenous busulfan, melphalan, thiotepa) for auto-HSCT. Pharmacokinetic blood samples of MIT-001 was collected at 5 time points including before administration to 24 hours after the start of the first and last administration of MIT-001. WHO criteria and NCI-CTCAE (v5.0) for OM grading were used for the severity of OM, which was evaluated daily during hospitalization and twice a week or once a week after discharge by investigator's choice. Pain related to OM was collected from patients using the Oral Mucositis Daily Questionnaire. Results: In part 1, total of sixteen patients were enrolled in which 5 patients were assigned in 5 mg and 20 mg group each, and six patients were assigned in the 10 mg group. Twelve lymphoma patients and four MM patients were pre-conditioned by BMT and Melphalan regimen, respectively. Severe OM (grade 3) were observed in two lymphoma patients treated with 10 mg and 20 mg MIT-001 (FAS: 13.3%, 2/16). Two patients with grade 3 OM had experienced radiation therapy of head and neck area within 1 year. Severe OM (&amp;gt; grade 3) did not occur in the four MM patients, while grade 2 was observed in two patients. None of the patients received total parental nutrition feeding due to OM. The median duration of grade 3 OM was 6 days (range, 3 to 9) and mean onset was 6 days (SD±1) after conditioning initiation. The duration and incidence of OM were not significantly different among the 3 groups. Mean area-under-the-curve (AUC) score for patient-reported soreness of the mouth and throat was not proportional to the dose of MIT-001. Time to engraftment was observed at a median time of 13 days (range, 11~ 26 days) determined by the neutrophil and platelet recovery time following auto-HSCT, which was within the normal range of period of auto-HSCT when compared to historical control. With the statistical analysis using the Kruskal-Wallis test, MIT-001 showed good PK profile with dose-proportionality in the range of 5 mg up to 20 mg. Two doses of 5 mg and 20 mg were determined as RP2D under steering committee. Serious adverse drug reactions were not reported. Part 2 is currently ongoing to evaluate efficacy of OM and safety of MIT-001 in forty-five patients with lymphoma and MM, where fifteen patients were allocated in 5 mg, 20 mg, and placebo group. Conclusions: The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT.