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Malnutrition clinical trials

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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: NCT06207071 Not yet recruiting - Premature Clinical Trials

Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial

Start date: May 2024
Phase: N/A
Study type: Interventional

Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.

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.

NCT ID: NCT06130228 Not yet recruiting - Obesity Clinical Trials

Nutritional Therapy in Late-onset Pompe Disease

PDT-MIS
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

RATIONALE: Pompe disease (PD) is a recessive genetic disorder wherein the body cannot break down glycogen due to a mutation in the acid alpha glucosidase (GAA) gene, which encodes for acid alpha-glucosidase. The adult/late onset form (LOPD) leads to glycogen accumulation and autophagic buildup, causing progressive muscle weakness that leads to wheelchair dependence, reduced quality of life and premature death due to cardiorespiratory insufficiency. While nutritional strategies, such as the low carbohydrate/high protein and ketogenic diets, have been used clinically, they are difficult to maintain and have limited benefits. Multi-ingredient supplementation (MIS) allows for targeting of several underlying pathogenic pathways and may be more convenient than traditional dietary strategies, thereby improving both adherence and LOPD pathology.

NCT ID: NCT06116422 Not yet recruiting - Pediatric Obesity Clinical Trials

Nutrition and Obesity in Under-Represented Populations: Food Insecurity Research to Advance Science and Improve Health

NOURISH
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit limited to grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.

NCT ID: NCT06114199 Not yet recruiting - Clinical trials for Nutritional Deficiency in Pregnancy

Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.

NCT ID: NCT06102473 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.

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

The goal of this clinical trial is to evaluate the effect of a digital educational intervention of front-of-package warning labeling on the selection and purchase of food in elementary school children and their caregivers. The main question it aims to answer is: - What is the effect of a digital educational intervention on front-of-package warning labeling on food selection in children from primary schools in Mexico City, compared to a control group? Participants will be randomized into two groups. - The control group, the dyads (caregiver-schoolchildren), will receive general nutritional education. - The intervention group, will also receive guidance on reading labels and raise awareness about the impact of consuming processed or ultra-processed foods on health. The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete: - Multiple-choice evaluation (5 questions) to ensure theoretical understanding of the topics - Lunch register - 24-hour dietary recall - Survey of food habits and consumption - Validated food preference questionnaire - Anthropometric measurements (Weight, height, waist circumference, body mass index) - Socioeconomic survey - Participate in a simulated online selection and shopping of food and beverages. To see if the digital educational intervention in the front of package warning labeling in children and caregivers will improve the selection and purchase of foods.