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81 active trials for Malnutrition

Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo

The proposed research will adapt the caregiver training and child neurodevelopmental assessment capacity that the PI previously built in Uganda beginning in 2008, to a community-based intervention model for the prevention of konzo in the Democratic Republic of Congo.

Start: April 2021

nutritionDay in Nursing Homes Worldwide: An International Audit and Registry on Nutrition and Outcome

Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary: to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition, to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units, to allow comparison with other facilities (with similar profile) with the help of a benchmarking system, to assess the effectiveness of introduced changes in terms of quality management and quality improvement.

Start: February 2007

Amino Acid Nutrition in the Critically-ill

Enhancing the anabolic effect of nutrition in critically ill patients by administering exogenous amino acids.

Start: March 2017

NutritionDay in Worldwide Hospitals: An International Audit and Registry on Nutrition and Outcome

Malnutrition at hospital admission is a risk factor for an unfavourable outcome, prolonged hospital stay and delayed recovery. In these patients the incidence of complications such as nosocomial infections, poor ventilatory function, prolonged bed rest is increased. In addition a relevant proportion of patients have a nutritional intake below their needs during hospitalisation.Mortality has been shown to be up to 8 times higher and dependency at discharge up to 3 times more frequent when actual food intake was below 25% of calculated needs. The aim of this international cross-sectional multicentre audit and registry is to generate a risk and level of nutritional intervention profile for an individual unit/ward based on case-mix, nutrition care and available structures. This profile should give a snapshot on the relation of risk to resource allocation. The audit is unit centered. Each unit gets as a feedback anonymously its position compared with all other participating units. Risk adjustment for selected patient groups, social environments and structures is planned. In conclusion this audit/registry will serve five distinct aims: Generate a precise map of the prevalence of malnutrition before admission and of decreased nutrient intake according to risk factors, medical specialty, organisational structures and countries. Increase in awareness for clinical nutrition in patients, caregiver and hospital managers. Enlarge and maintain a reference database for hospitalised patients Provide individual unit benchmarking

Start: January 2006

Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia

The world population is ageing rapidly as a result of low fertility and mortality rates and increasing life expectancies. Old age people (age 60 years and above) shared 962 million or 13% of the global population in 2017 and expected to be two billion by 2050. As individuals grow old, their dietary pattern changes and the risk of malnutrition estimated between 11.8% to 27% in the community elderly people. Ageing and nutrition are by far the number-one driver of the global burden of disease: every country is facing. Early assessment and management of malnutrition among old age people can minimize the negative consequences, extending to better health status and quality of life. Nutrition counselling is one of the first line of nutritional therapy. However, malnutrition in old age people remains under-detected, under-treated and under resourced, and is often overlooked in low-income countries like Ethiopia. Furthermore, nutritional interventions targeted to old age people are lacking in the country. Therefore, this study is intended to estimate the effects of nutrition counselling on old age people's nutritional status and quality of life in Bahir Dar City, Northwestern Ethiopia

Start: April 2021

The Bangladesh Environmental Enteric Dysfunction Study

This is a community-based intervention study which will be undertaken at Mirpur, Dhaka, Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18 months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted children (length for age Z score, LAZ < -2), children who are at risk of stunting (length for age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for any organic diseases and application of inclusion/exclusion criteria, they will receive nutrition interventions. Participants eligible for study will be tested for potential bio markers of environmental enteropathy (stool, urine and serum) once before and once after the nutritional intervention. Participants who will fail to respond to nutritional therapy (measured by anthropometric assessment) will become candidates for upper gastrointestinal endoscopy with biopsy. The study will include duodenal biopsies from a control group of children from University of Virginia Hospital in Charlottesville, Virginia who will undergo upper GI endoscopy as part of their clinical care as per the standard clinical protocol followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka.

Start: July 2016

Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota

Participants will be randomly assigned to the experimental group where they will be given enteral nutrition formula rich in zinc and arginine plus a symbiotic (Probinul- Ca.Di.GROUP S.r.l.) once a day for 90 days or the control group where they will receive only the enteral nutrition formula rich in zinc and arginine.

Start: June 2017

Assessment of Nutritional Status of Patients With Crohn's Disease

Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease. The prevalence of malnutrition in patients with Crohn's disease varies and is higher in patients with active disease. Available studies in the literature have assessed the nutritional status of patients with Crohn's disease. However, sample size of available studies is small and highly heterogeneous, and most patients are hospitalized with active disease. The aim of the present study is a thorough assessment of nutritional status of 220 patients either with active Crohn's disease or in remission of the disease using multiple widely available tools and methods, in order to assess their accuracy and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition, sarcopenia, sarcopenic obesity and cachexia. Finally, the effect of the nutritional status on the course of the disease will be investigated.

Start: December 2018

Tuberculosis - Learning the Impact of Nutrition

The proposed work is based on the finding that one-third of the world is infected with the bacteria Mycobacterium tuberculosis (Mtb) and only 10% of these individuals develop TB. The study aims to identify factors that drive progression to disease and study signals (markers of the immune response) that detect who will progress to active TB and why this happens. Armed with these markers, the study will address how malnutrition and worms alter this signal profile to cause active TB. The work will be conducted in India, where there are 2.8 million TB cases each year - more than any other country - and where the government has committed to eliminating TB by 2035. Data suggest that malnutrition and parasites increase risk of TB disease so the investigators will feed malnourished household contacts and have those with parasites receive medication to treat these. Using this infrastructure, the investigators will evaluate the immunologic impact of feeding on TB pathogenesis. An additional aim is to understand the role of parasitic worms with the goal of determining the utility of low-cost ($.02 per dose) worm treatment as part of TB control efforts. Risk of developing TB will be evaluated for 120 household contacts of TB patients in the setting of their malnutrition and parasites. There are four study arms comprised of thirty participants each -- malnourished with parasite infection, malnourished with no parasite infection, well-nourished with parasite infection, and well-nourished with no parasite infection. Correlates of risk of disease will be assessed using blood mRNA/miRNA sequencing and T cell immune markers. The TB LION study will confirm that malnutrition and worms increase the risk of active TB and will provide the basis for effective interventions that could change the face of the TB pandemic and have a profound impact on the health of people worldwide. Participants in this study will be household contacts of tuberculosis index cases. The index cases in this study do not participate in the study once a household contact is established. All interventions and follow up are only being conducted within the household contact cohort. All intervention supplies, treatments, and biologics will be purchased internationally.

Start: July 2019

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study (MCC Study)

The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600. The aims of the study include: Assess the interrater reliability of the MCC. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes. Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients. Identify the utility of BIA for body composition analysis in clinical settings. Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.

Start: June 2019

Oral Nutritional Supplement for the Patient With or at Risk of Malnutrition

In case of acute and chronic illness nutritional problems are widespread, and a reduced dietary intake in combination with effects of catabolic disease rapidly lead to malnutrition. A high prevalence of protein energy malnutrition in patients has been reported. A close relation between malnutrition and re-admission rate, cost of hospital care in terms of length of stay in hospital as well as mortality has been documented. A Cochrane review of the use of oral nutritional supplementation suggested that oral nutrition not only provided nutrients, but also has significant improvements on psychological and social functions, possibly through enhancing sensation of taste and flavor which is an important mediator of pleasure and well-being. Therefore, an oral option of nutrition is always considered as the first choice of nutritional intervention, in particular in situations where nutritional interventions, such as assisted feeding, are difficult, time-consuming and demanding due to advanced morbidity and slow responses. In this randomized controlled trial, the investigators will explore the gaps of nutritional needs and the potential use of nutrition supplementation in the management of malnutrition among patients in Hong Kong. The investigators aim to improve the nutrient intakes and the nutritional status of participants through a specially formulated oral nutrition supplement titled "Fresubin® Powder Fibre" to reverse malnutrition status due to acute and chronic illness. Fresubin® Powder Fibre is a nutritionally complete powder product to be reconstituted in different caloric densities (1.0 to 1.5 kcal/ml) and containing high quality protein and vitamin D for the dietary management of participants with or at the risk of malnutrition.

Start: November 2020

Identification of Risk Patients in Emergency Medical Services

Background: Inadequate nutrition has been associated with growing risk of falling and impaired ability in elderly patients. Falling is a significant threat to the health of the elderly. It is estimated that one third of people over the age of 65 experience at least one falling each year. Over 60% of the falls cause serious injury or disability. Adequate nutrition increases the muscle strength of the elderly. Therefore, determining and managing the nutrition level is important for preventing falling. As far as we know emergency medical services has never before reported being a part of prevention by performing risk identification.

Start: September 2018

Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. Malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. This study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.

Start: December 2020

Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant

Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.

Start: March 2016

Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes

Older adults (? 55 years) who do not eat enough nutritious food are at risk of malnutrition. Malnutrition can lead to frailty, hospitalization, poor quality of life, and death. SCREEN (Seniors in the Community Risk Evaluation for Eating and Nutrition) is the leading nutrition risk screening tool for cognitively well older adults living in the community. The purpose of this study is to determine if SCREEN can be used to find nutrition risk among older adults diagnosed with mild cognitive impairment or dementia (i.e., MCI-D) living in the community and persons living in retirement homes. SCREEN and other nutrition and health measures will be completed in 600 older adults (300 living in retirement homes with or without MCI-D, and 300 living with MCI-D in the community). SCREEN will be completed twice to determine reliability, and persons with MCI-D will have their results compared to those of a caregiver who completes it on their behalf. A dietitian's assessment and rating of nutrition risk will be used as the gold-standard to determine validity.

Start: June 2021

Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry

The HEALTH Registry is a prospective, observational, non-interventional registry study of patients receiving home parenteral nutrition therapy in the US for a variety of indications.

Start: June 2019

The Effect of Higher Protein Dosing in Critically Ill Patients

The investigator will investigate the effects of higher protein/amino acid dosing (?2.2 g/kg/d) vs usual protein/amino acid dosing (?1.2 g/kg/d) on clinical outcomes in nutritionally high risk ill patients.

Start: November 2017

Give a MANNA a Fish, Teach a MANNA to Fish

This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive low sodium MANNA meals to encourage improved dietary compliance. Outcomes of these interventional patients will be compared to those receiving standard of care--namely, educational intervention by physicians supplemented by occasional counseling from dieticians during clinic visits encouraging a low sodium diet. Dietary compliance will be evaluated by urine sodium and salt affinity tests and used as a positive marker for improved outcomes. The target population of this study is patients diagnosed with cirrhosis of the liver, aged 18-85 years living within the MANNA-serviced area.

Start: March 2021

Effectiveness and Cost-Effectiveness Study of Medical Nutrition in Malnourished Patients in Spain

The present study aims to evaluate the use of oral nutritional supplementation in persons with some clinical conditions presenting malnutrition in some extent.

Start: November 2019

An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.

Start: February 2020