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Malnutrition clinical trials

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NCT ID: NCT06277232 Not yet recruiting - Clinical trials for Overweight and Obesity

Nutrition Care in Patients Living With Chronic Pain

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain. The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes.

NCT ID: NCT06274788 Not yet recruiting - Malnutrition Clinical Trials

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population

NCT ID: NCT06244407 Not yet recruiting - Healthy Volunteer Clinical Trials

The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions

Start date: May 23, 2024
Phase: Phase 1
Study type: Interventional

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions

NCT ID: NCT06233149 Not yet recruiting - Healthy Subjects Clinical Trials

Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition

Start date: October 1, 2024
Phase: Phase 1
Study type: Interventional

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, full replicate crossover design with four-period, two-treatment, and two-sequence under fed condition and at least 7 days washout period between the doses.

NCT ID: NCT06228339 Not yet recruiting - Healthy Volunteer Clinical Trials

The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions

Start date: March 9, 2024
Phase: Phase 1
Study type: Interventional

Objective: Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period. Study Design: A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study

NCT ID: NCT06212765 Not yet recruiting - Malnutrition Clinical Trials

Oral Citrulline Supplementation in COPD Patients With Malnutrition

CITRUS
Start date: January 25, 2024
Phase: Phase 3
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown. The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI < 20 kg/m2 if < 70 years old or < 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.

NCT ID: NCT06206694 Not yet recruiting - Malnutrition Clinical Trials

Serum YKL-40 Levels is Associated With Nutritional and Oxidative Status of Hemodialysis Patients

Start date: May 1, 2024
Phase:
Study type: Observational

Background YKL-40 is a glycoprotein that had been reported to be associated with inflammation atherosclerosis and endothelial dysfunction. The objective is to explore the association of serum YKL-40 levels with nutrition status, inflammation, and body composition in a cohort of hemodialysis patients Methods We plan to recruit 400 prevalent HD patients. Their baseline serum YKL-40 levels, body anthropometry, the profile of insulin resistance, bioimpedance spectroscopy parameters, and nutritional indices will be measured.

NCT ID: NCT06155474 Not yet recruiting - Child Malnutrition Clinical Trials

Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition

P-MAM
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Malnutrition is a major global public health issue, contributing to poor health and early morbidities in children under five, particularly in developing countries. In 2021, 5 million children died worldwide due to infectious diseases or malnutrition, with Pakistan having the highest under-five mortality rate. With a population of approximately 229 million, Pakistan is the fifth most populous country in the world. In Pakistan, under-five mortality is 63.3 per 1000 live births which has declined from 139.8 in 1990 to 63.3 in 2021 (WHO, 2022, UNICEF, 2023). The monsoon season's massive flooding in Pakistan has worsened the humanitarian situation, endangering the already vulnerable population. UNICEF reports high rates of acute malnutrition, political instability, economic decline, and coronavirus disease 2019 effects. However, there is limited evidence on the efficacy of probiotics for infants in Pakistan. Metagenomics is the study of microorganisms' genomes, examining all microorganisms in an ecological site's genomes. It involves extracting and sequencing DNA using high-throughput techniques. Scientists can identify genes with significant features using computer analysis. The distal intestine contains around one trillion organisms per milliliter of luminal contents, and understanding their potential for energy and nutrient harvest is crucial in malnourished individuals. Alpha diversity is the analysis of species diversity in a sample, measured by observed species index, Chao1 index, Shannon index, Simpson index, and good-coverage index. It is proportional to the first four values and indicates less undiscovered species. The distal intestine contains around one trillion organisms per milliliter of luminal contents, with an increased capacity for energy harvest in malnourished individuals. The present study aims to measure the following objectives. i. -To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing. ii. -To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition. iii. -To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.

NCT ID: NCT06144411 Not yet recruiting - Malnutrition Clinical Trials

Recording and Evaluating Preoperative Malnutrition in Electively Scheduled Adult Surgical Patients With the GLIM Criteria (GLIM-study)

GLIM
Start date: June 2024
Phase:
Study type: Observational

Data about the prevalence of preoperative malnutrition according to all the five GLIM criteria among the broad range of surgical patients are lacking. The current study will investigate the prevalence of malnutrition according to all of the five GLIM criteria in electively planned surgical patients in a large academic hospital, the Amsterdam University Medical Centres, location AMC, where over 11.000 patients are operated on yearly.

NCT ID: NCT06141785 Not yet recruiting - Cancer Clinical Trials

Early Nutritional Intervention in Patients With Cancer

NICOS
Start date: February 2024
Phase: N/A
Study type: Interventional

The goal of this intervention study is to study the effect of nutritional interventions in patients with cancer receiving palliative chemotherapy. The main question it aims to answer is: Does early nutritional interventions affect body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk and treatment tolerance in patients with cancer receiving palliative chemotherapy? Researchers will compare patients receiving the intervention to a historical control cohort following current clinical practice.