Clinical Research Directory

the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children

The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.

The Florida ASCENT Study

The goal of this clinical trial is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with cancer. The main hypotheses it aims to test are: * At the patient level, the intervention will result in higher levels of food security, self- efficacy for dietary behaviors, and higher diet quality than standard care. * At the provider level, the intervention will be feasible, acceptable, appropriate, and able to enhance individualized care for patient wellness. Researchers will compare cancer patients receiving the MyCarePulse and ASCENT patient navigator intervention to those receiving standard care, to see if the intervention improves food security, self-efficacy, and diet quality. Phase 1 Patient Participants will: * Complete the ASCENT Questionnaire, which is comprised of the following: * U.S. Food Security Survey Module (U.S. FSSM) * Patient-Reported Outcomes Measurement Information System (PROMIS-29) * Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool * Be assessed using the Veggie Meter instrument * Participate in two semi-structured interviews Provider Participants will: •Participate in one semi-structured interview Phase 2 Patient Participants will: * Participate in ASCENT patient navigator screenings and consultations * Complete the ASCENT Questionnaire, which comprises the U.S. FSSM, PROMIS-29, and ASA24®

An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

ASPIRE is a nutrition study focusing on the effect of arginine supplementation on immune function in postoperative infants. The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term/near term infants. 16 of these infants (8 preterm and 8 term/near term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative infants The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.

Development and Testing of Nutritional Algorithms (NACHO)

The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment. The name of the intervention used in this research study is: Nutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)

Enhanced Nutritional Optimization in LVAD Trial

The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.

PUSH-IT Continuing Enteral Feeds for Tracheostomy

The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are: * Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake? * Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections? Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.

Vitality in Infants Via Azithromycin for Neonates Trial

Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (\<2500 g at birth) or underweight (weight-for-age Z-score \< -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight/underweight neonates, who are at the highest risk of adverse outcomes.

Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery

This is a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. The primary endpoints are body weight and frailty prevalence, The secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.

Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients

The aim of this study was to investigate the effects of enteral nutrition content on disease progression in sepsis patients.

Nutritional Supplementation in Head and Neck Cancers

The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.

Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes

Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes. The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.

Polish Infants and Toddler Nutritional Study

A cross-sectional study representative of the Polish population of children aged 5 months to 6 years conducted in the cross-sectional study model, the main objective of which is to assess the nutritional value of the diet of children aged from 5 months to 6 years with regard to the basic macronutrients: protein (P), fat (F), carbohydrates (C). The study will include: dietary interviews, which will include the Food Frequency Questionnaire questionnaire (FFQ) and a 3-day food diary, as well as anthropometric measurements. The study will involve 1,000 children who will be selected by a random draw based on government database. The survey will be conducted by trained field interviewers - training will be provided by a dietician and an anthropologist. The study also included validation of the FFQ questionnaire.

Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)

Celiac disease is a disorder commonly diagnosed during childhood. The treatment is a lifelong gluten-free diet. Both the condition and the diet can influence the children's physical and emotional well-being. The main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children. The nutritional assessment includes information on diet, biochemical measurement, and body composition. Quality of life will also be assessed. The study can contribute to ensure good health and well-being in children on a gluten-free diet.

ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts

This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content. * Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content * Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content * Differences regarding body composition when using enteral nutrition formulas with different protein content

Enteral Zinc Supplementation in Very Low Birth Weight Infants

The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer: • Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups * Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive \~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first. * The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.