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Nutrition Disorders clinical trials

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NCT ID: NCT03894566 Active, not recruiting - Mental Disorders Clinical Trials

NASCITA Italian Birth Cohort Study

NASCITA
Start date: April 1, 2019
Phase:
Study type: Observational

The NASCITA study (NAscere e creSCere in ITAlia) was created to improve the understanding of the health status of Italian children early on and how it is affected by social and health determinants. The study will evaluate physical, cognitive, and psychological development, and health status and health resource use during the first six years of life in a group of newborns, as well as potential associated factors. The association between the well-being of children and parental adherence to the recommendations for better child care and development will also be assessed. Information on the children will be collected by paediatricians mostly during routine visits. The findings will be used in the development of specific prevention measures and interventions to improve the health of children, in particular more vulnerable ones.

NCT ID: NCT03865706 Active, not recruiting - Sepsis Clinical Trials

Inulin for Infections in the Intensive Care Unit

Start date: October 14, 2019
Phase: Phase 2
Study type: Interventional

Normal gut bacteria prevent colonization and subsequent infection with MDR organisms (MDROs) through competition for resources and other mechanisms. During critical illness, this function of the microbiome is lost and there are no current treatments to restore it. Preliminary data indicates that the prebiotic fiber inulin is safe and may alter the gastrointestinal microbiome to improve gut barrier function, decrease colonization with MDROs, and reduce downstream risk for intensive care unit (ICU)-acquired MDR infections. However, the impact of inulin during critical illness is unknown. This double-blind, randomized clinical trial will test inulin for the prevention of antibiotic resistant infections in the ICU. The trial's specific aims are to determine (1) the feasibility, tolerability, and safety of inulin in the intensive care unit; (2) the impact of inulin on gut colonization with antibiotic-resistant pathogens; and (2A/exploratory) the impact of inulin on ICU-acquired antibiotic-resistant infections.

NCT ID: NCT03843424 Active, not recruiting - Overweight Clinical Trials

Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers

TEAM UP
Start date: September 12, 2019
Phase: N/A
Study type: Interventional

The US Preventive Services Task Force (USPSTF) recommends that providers screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention (≥26 hours over a period of up to 12 months) to promote improvement in weight status. Family-based behavioral treatment (FBT) is an effective treatment that targets both child and parents and meets the USPSTF recommendations. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling, which begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Our study compares a staged approach enhanced standard of care (eSOC) vs. eSOC + FBT, to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Our project seeks to fill the gap in the evidence on family-based weight management in primary care settings among diverse and underserved populations with a special focus on Black children, families insured by Medicaid, and sex differences.

NCT ID: NCT03509155 Active, not recruiting - Wasting Clinical Trials

Food Supplement Treatment for Wasting Children in Indonesia

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Assessing program efficacy of under five food supplementation (PMT Biscuits) is needed after the first 6 months of exclusive breastfeeding, children were introduced to liquid and semi-solid food. In this phase of food introduction, children ability to accept food supplementation program was still questionable and the efficacy needs to be assessed. Another aspect that needed to be evaluated is assessing the efficacy of food supplementation to improve the nutritional status of wasting children in multiple cities to describe Indonesian geographical and socio-economic diversity (multi center studies). PMT biscuits supplementation intervention is accompanied by educational modules on Infant and Young Child Feeding (IYCF) in order to improve caregiver's knowledge and skills in providing economically affordable and nutritious food for their children. PMT biscuits supplementation evaluation will be assessed at 9 months observations (3 months intervals). The observation will be conducted every month up until the first 3 months then the observation will be continued in 6th and 9th months of observation.

NCT ID: NCT03475368 Active, not recruiting - Nutrition Disorders Clinical Trials

Interactions Between Diet, Intestinal Microbiota and Metabolomics

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

It is widely known that the quality of the diet is able to modify the expression of many bacterial genes populating the intestine of the host, as well as the type of bacteria themselves. This is also expressed with a more or less evident and troublesome after meals symptomatology that many patients complain to the health care staff. A good composition of the microbiota is crucial for the health of the individual, both at the intestinal level as well as at the systemic level because, depending on the type of food substrate available at the intestinal level, metabolites will be produced capable of positively or negatively affect the health of the individual. In fact, scientific evidence shows the existence of the causal link between the health of the microbiota and the genesis of inflammatory diseases not only intestinal, but also systemic, and even of cancer, obesity, metabolic syndrome and atherosclerosis. The recent diffusion of gene sequencing techniques has brought significant developments in the study of the human and bacterial genome, which allow to produce enormous quantities of sequences at a lower cost and at a higher speed than previous techniques. Therefore the clinical Nutrition Clinic of the IRCCS De Bellis in Castellana Grotte (BA) proposes to check if changes in the intestinal microbiota correlate, not only with anthropometric and clinical-laboratory parameters, but also with the typical symptoms of irritable bowel syndrome (IBS), a functional pathology very widespread with the advent of the modern era, in which, a diet rich in sugars and proteins of animal origin and poor in plant foods, is unfortunately common also in the areas of the Mediterranean basin.

NCT ID: NCT03451968 Active, not recruiting - Clinical trials for Metabolism and Nutrition Disorder

Amino Acid Metabolism in Fed Surgical Critically Ill Patients

Start date: December 2, 2018
Phase: N/A
Study type: Interventional

Introduction Sarcopenia is defined as progressive generalized loss of skeletal muscle mass, strength and function. Sarcopenia due to lack of physical activity is a known phenomenon and is usually observed as a normal part of aging or in certain diseases and pathogenic processes. Major associated factors causing development of sarcopenia may be summarized as interactions of environmental and hormonal factors, underlying diseases, activation of inflammatory pathways, mitochondrial dysfunction, reduced satellite cell numbers, and loss of neuromuscular junctions. Intensive care acquired weakness (ICU-AW) known formerly as critical illness polyneuropathy, is a diagnosis that becomes more common as survival rates from long ICU hospitalization are more prevalent. It is characterized by a primary axonal degeneration, without demyelination, that typically affects motor nerves more than sensory nerves. ICU-AW affects the limbs (particularly the lower extremities) in a symmetric pattern. Weakness is most notable in proximal neuromuscular areas (e.g., the shoulders and hip girdle). In addition, involvement of the respiratory muscles can occur and can impede weaning from mechanical ventilation. The pathophysiological mechanisms of ICU-acquired weakness are believed to be multifactorial. Some suspected factors include dysfunctional microcirculation and hyperglycemia. It has been shown that tight glucose control in ICU patients reduces the risk for ICU-AW (although it has been associated with other adverse events). Sodium channels channelopathy is also a researched cause for ICU-AW. Muscle loss in the ICU are usually related to bedridden condition and lack of mobility, increase in ubiquitination and inadequate protein administration associated with large negative nitrogen balance. In addition mechanical ventilation contributes greatly to this problem. This has been particularly relevant in post trauma/surgical long stayer patients. In the past years great progress was made in the investigation of protein balance, breakdown and synthesis using stable isotope tracers in various medical conditions. In a research performed in PICU (1-5) and ICU (6, 7) regarding the measurement of plasma amino acid during critical illness, stable phenylalanine, tyrosine leucine, arginine and citrulline isotope were used intravenously without any safety issue problem. Another study was performed on adults suffering from COPD with matched healthy adults, using stable isotopes of phenylalanine, tyrosine leucine, isoleucine and valine (8). During the study the isotopes were given parenterally as well as enterally. The study showed significant change in splanchnic extraction of various amino acids and higher turnover of BCAA in COPD patients. Using the theory that supplemental milk can compensate for the elevated turnover of BCAA in COPD patients, using the isotope analysis demonstrated that this theory was proven wrong and the conclusion was that alterations are present in BCAA metabolism despite normal plasma levels in normal weight COPD. Further research is needed to find a way to compensate for it. These studies and other recent studies (9-19) show us the safety regarding the use of stable isotope tracers whether IV or PO, while giving us the opportunity to assess the metabolism of amino acid in all sorts of pathological states. Hypothesis & Aim of the study We think that based on current literature, there are important differences between critically ill patients and healthy population in the amino acid profile and distribution in the body as well as synthesis and breakdown. The aim of the study is to measure these differences in long ICU stayers (above 7 days) admitted in the ICU after surgical/trauma injury, and to try and help aiming future treatment and research in this field.

NCT ID: NCT03310983 Active, not recruiting - Clinical trials for Pregnancy; Nutritional Diseases

Growth and Adiposity in Newborns: The Influence of Prenatal Docosahexaenoic Acid (DHA) Supplementation

ADORE-GAINS
Start date: November 1, 2017
Phase:
Study type: Observational

The purpose of this study is to learn if participants in the ADORE study (NCT02626299), who took a DHA supplement during pregnancy, see favorable body fat in their infants from birth to 24 months, and if excessive or appropriate weight gain during pregnancy impacts this result.

NCT ID: NCT03179657 Active, not recruiting - Obesity Clinical Trials

Guangzhou Nutrition and Health Study (GNHS)

GNHS
Start date: July 1, 2008
Phase:
Study type: Observational

Purpose: The Guangzhou Nutrition and Health Study (GNHS) project aims to assess the determinants of metabolic disease in nutritional aspects, as well as other environmental and genetic factors, and explore possible mechanisms with multi-omics integration. Study design: GNHS is a community-based prospective cohort study. Participants: In this cohort, the original GNHS and another cohort study (the controls of a case-control study of hip fractures, CCFH) have been integrated into the one GNHS project. After completing the baseline examination, a total of 5118 participants were recruited during 2008-2015 in the GNHS project. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, dual-energy x-ray absorptiometry (DXA) scanning, ultrasonography evaluation, vascular endothelial function evaluation, cardiopulmonary exercise testing, magnetic resonance imaging (MRI), 14-d real-time continuous glucose monitoring tests, laboratory tests, and multi-omics data were/will be conducted. Up to December 2022, 3442 and 2895 subjects completed the 2nd and 3rd visits. Key variables: 1. Questionnaire interviews. 2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, muscle function and bracelet motion monitoring. 3. DXA scanning: To determine bone density, bone mineral content, bone geometry information, fat mass, and muscle mass. 4. Ultrasonography evaluations: To determine carotid artery intima-media thickness and plaque, and fatty liver. 5. Vascular endothelial function evaluation. 6. Cardiopulmonary exercise testing: Lung function. 7. MRI: Brain and upper-abdomen MRI. 8. 14-d Real-time continuous glucose monitoring tests. 9. Specimen collections: Overnight fasting blood, early morning first-void urine, faces, and saliva samples. 10. Laboratory tests: Metabolic syndrome-related indices; Diabetes-related indices; Uric acid; Nutritional indices; Inflammatory cytokines; Index of oxidative stress; Adipocytes; Sexual hormones; Liver and renal function-related markers; Routine blood test. 11. Multi-omics data: Genotyping data; Gut microbiota; Untargeted serum and fecal proteomics; Targeted serum and fecal metabolomics. 12. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.

NCT ID: NCT02770196 Active, not recruiting - Pediatric Obesity Clinical Trials

Intervention Study of Cost-Offset Community Supported Agriculture (CO-CSA)

Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to better understand how participation in cost-subsidized community supported agriculture programs paired with tailored education can affect diet quality and energy balance among children in low-income households.

NCT ID: NCT02159456 Active, not recruiting - Nutrition Disorders Clinical Trials

Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients

Start date: May 2014
Phase: N/A
Study type: Interventional

1. Nutritional support during critical illness is important to improve the clinical outcome of patients. Recently, the apply of early enteral nutrition is recommend in critically ill patients on basis of data that enteral nutrition can be helpful to prevent the hospital-acquired infections. - However, in critically ill patients, the smooth progress of nutritional support is often hindered by gastrointestinal intolerance, underlying clinical condition, and temporal necessity of procedure or operation. - Continuous feeding method, compared with intermittent feeding, is expected to reduce the risk of gastrointestinal intolerance, and improve the nutritional support, but this hypothesis is not supported by appropriate evidences. 2. We will elucidate to compare the efficacy and safety of the continuous feeding method in critically ill patients, compared with the intermittent feeding method. - Prospective, randomized controlled study - Primary outcome: the achievement rate of target nutritional goal within 7 days after the start of enteral nutrition - Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical ventilation