COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks.
MalnutritionAt least one fifth of patients in European hospitals are malnourished. Malnutrition is associated with negative consequences, including higher rates of complications, longer hospital stay, impaired wound healing and increased mortality with consequent effects on costs of healthcare. Evidence suggests that there may be benefits to some malnourished patients from receiving oral nutrition supplements in the short-term but it is not known whether these benefits can be sustained and indeed whether similar benefits may be achieved using food-based interventions of lower cost. The overall objective of the study is to compare two nutritional interventions among malnourished patients with COPD (n=200); oral nutrition supplement (ONS) vs. energy and protein dense in-between meals snack during hospitalisation and at home. Subjects will be followed for one year. The primary endpoint is weight change. Secondary endpoints include forced expiratory volume in one second, forced vital capacity, six-minute walk distance, hand-grip strength, health related quality of life, length of hospital stay, energy- and protein intake, readmissions to the hospital and acute exacerbation. No studies are available comparing the supply of ONS to malnourished patients with COPD compared with the provision of regular food (in-between meals snacks). The results of the study will provide important information that might improve nutrition care in the hospital setting as well as after discharge from the hospital
Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support.
MalnutritionThe purpose of this trial is to evaluate the efficacy and safety of the implementation of an Algorithm for enteral nutrition support compared with usual standard practice in non-critical hospitalized patients: ASNET algorithm.
PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition...
HealthyThe purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children
MalnutritionChildren hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases. We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.
Malnutrition in Gastroenterology Patients
MalnutritionBackground: Malnutrition is frequently occurring in sick patients and is associated with a higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which leads to a reduced functional status and quality of life. Specific aims: The purpose of the study is to evaluate the effect of a three month nutritional intervention with oral supplements on nutritional status, muscle function and quality of life.
Effectiveness Trial of Day-care vs. Usual Care of Severe Pneumonia & Malnutrition in Children
Pneumonia ChildhoodBackground: At present pneumonia and malnutrition have become the leading causes of mortality among <5-year-old children in developing countries. World Health Organization standard management of severe pneumonia and severe malnutrition requires hospitalization for supportive care. As many developing countries including Bangladesh do not have enough pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia and malnutrition, Investigators developed alternative treatment option such as "Day Care Approach", for those children who cannot be hospitalized, but are too sick to be managed in the community. After successful Day Care Approach of management of efficacy trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct an effectiveness trial under "real life" condition, i.e. within the Health Systems of Bangladesh. Burden: Pneumonia is the leading cause of mortality in developing countries, being responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6 million children dying annually because of Severe Acute Malnutrition & Moderate Acute Malnutrition, respectively. Objectives: To assess & implement the Day Care Approach of management of severe childhood pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment. Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving 16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly assigned to intervention & control arm. Children with severe pneumonia will be enrolled in (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in urban and Health and Family Welfare Centres in rural areas. Outcome variables: Primary: clinical treatment failure by day 6 Secondary: (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost effectiveness (iii) Referrals to hospitals (iv) Deaths
Hands On Nutrition Education to Improve Childhood Health
Health BehaviorNutrition PoorThe main goals of this study is to better understand how an experiential cooking, movement and mindfulness intervention influence elementary school children at Spring Valley School. program diet, fitness, metabolic outcomes, health literacy and overall well-being. Specifically, the role of the novel empowering experiential learning through a cooking and fitness intervention activities will play on health literacy and metabolic outcomes, engagement in fitness and motivation, and stress levels will be evaluated.
Early Enteral Nutritional Supplementation on Patients With Oral Cancer Undergoing Radio(Chemo)Therapy...
MalnutritionThe target population in the present study is Chinese patients with oral cancer who plan to receive radio(chemo)therapy after surgical resection in outpatient clinic department. Investigators hypothesize that enteral nutrition intervention, which is initiated 2 weeks before the start of post-operative radio(chemo)therapy treatment and ongoing 2 weeks after the completion of irradiation treatment, will improve patients' nutritional status, tolerability to radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of enteral nutrition during the course of irradiation treatment.
Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With...
Crohn DiseaseAbsorption; Disorder7 moreThis is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.
Intervening to Repair Cognitive and Behavioural Problems in Adults Exposed to Childhood Malnutrition...
Severe Acute MalnutritionCognitive Impairment1 moreGlobally, in 2011, 52 million children under 5 years old suffered from acute malnutrition, and a further 165 million children showed evidence of chronic undernutrition or stunting. It was also estimated that 3.1 million children died in 2011 of malnutrition related causes. The survivors, due to deprivation of critical nutrients in the most important period of development and growth, are left with permanent damage, including an increased risk of cardio-metabolic disease, poorer educational achievement and diminished earning potential. In Jamaica in 2012, 2.5% of children were moderately or severely underweight (more than two standard deviations below weight-for-age by international reference populations), falling from as high as 8.9% in 1993. Though there have been modest reductions in the incidence of acute malnutrition in Jamaica over the past 20 years, the risk remains high in poor families and among children who are being weaned. Hence, the problem is an ongoing one and we have a significant pool of survivors of childhood malnutrition who have now reached adulthood and face the consequences of early nutrient deprivation. The brain is particularly vulnerable to the effects of malnutrition and studies have demonstrated both structural (brain atrophy) and functional (cognitive impairment and poor academic achievement) changes. This evidence, however, has been mainly in later childhood and adolescence. In addition, there is local data that suggests that cardio-metabolic risk factors are increased in these adult survivors, which are well-described precursors of cerebrovascular disease and cognitive impairment. Therefore, in adulthood there may be accelerated cognitive decline due to a poor cardio-metabolic profile superimposed on pre-existing brain injury. We hypothesise that there are differences in cognitive function (poorer memory and executive function)and emotional responses in adult survivors of childhood malnutrition compared to those not exposed to early childhood malnutrition. There is evidence suggesting that aerobic exercise and omega-3 supplementation have some benefit in reversing cognitive decline in older adults, but they have not been investigated in survivors of childhood malnutrition.Hence, we propose to introduce a six month intervention of supervised aerobic exercise and omega-3 supplementation, and will compare cognitive function pre and post intervention/placebo between malnutrition survivors and controls.