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Malnutrition clinical trials

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NCT ID: NCT06119711 Active, not recruiting - Malnutrition Clinical Trials

Micronutrient Levels and Nutritional Status in Critical Illness

NUTRI-ICU
Start date: May 8, 2023
Phase:
Study type: Observational

Rationale: A significant proportion of patients admitted to the Intensive Care Unit (ICU) is unable to fully recover, even when the initial cause of their illness has been treated. Inadequate dietary intake prior to admission and during the recovery phase may leave patients in a frail physical state, limiting rehabilitation potential. Commonly used methods to assess nutritional intake and nutritional status are highly impacted by various disease-related confounders and reporting bias. We hypothesise that a combined assessment of biomarkers in plasma and urine may provide a more accurate overview of nutritional status at ICU-admission. Objective: Main: Assess nutrition-related biomarkers in plasma and urine samples at ICU admission Secondary: Identify the number of micronutrient deficiencies at ICU admission Compare biomarker profile and dietary intake of short and long-stay ICU patients at baseline Compare subjective dietary intake, nutritional status and muscle thickness between patients with and without micronutrient deficiencies at baseline Study design: Observational study Study population: Adult patients admitted to the ICU. Two groups will be recruited: patients with a short length of stay (<48 hours) and patients with a longer length of stay (≥48 hours). Main study parameters: Biomarker status in blood and urine at ICU admission. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to standard care ICU treatment, the following measurements will be performed: - Within 24 hours after admission blood and urine samples will be collected from existing venous line and urinary catheter - Within 72 hours an ultrasound measurement of the upper leg will be performed. - During ICU stay, when the patient is capable to do so, they will be asked to complete a retrospective dietary intake assessment. The risks and negative effects of these tests are limited. However, this study asks for a time investment and physical and mental effort of the patients.

NCT ID: NCT06068816 Active, not recruiting - Malnutrition Clinical Trials

Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients

Start date: June 5, 2022
Phase: N/A
Study type: Interventional

The primary outcome is the mean difference in energy and protein as well as a selection of micronutrients (calcium, vitamin D, and Vitamin B12) after 12 weeks of intervention between standard care plus nutritional supplementation vs standard care. The secondary outcomes are body weight, nutritional status, body composition, physical performance, vitamin D level, and nonelective hospitalization The Study Hypothesize: The hypothesize that outpatients who receive nutrient-dense drinks (NDD) will have increased body weight, better nutritional status, better body composition, higher vitamin D level, better physical performance and reduced non-elective hospitalization than those receiving standard care after 12 weeks of intervention.

NCT ID: NCT06038344 Active, not recruiting - Clinical trials for Adherence, Treatment

Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease

Start date: June 22, 2021
Phase: N/A
Study type: Interventional

Celiac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of sugar and fat. Current Canadian nutrition guideline does not address these nutritional limitations. The investigation team developed a novel GF-food guide (GFFG). This randomized clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD in newly diagnosed children and youth with celiac disease in the clinical setting. The investigators will compare dietary counselling using the GFFG versus the standard of care in children newly diagnosed with CD and their parents to see if participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) improved over six months.

NCT ID: NCT05885191 Active, not recruiting - Clinical trials for Malnutrition; Protein

True Ileal Amino Acid Digestibility of Tenebrio Molitor Larvae in Women

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

Dietary protein intake of adequate quality is essential for human health. Traditional animal source foods play a key role in providing high quality protein but are associated with a high burden on the environment. Therefore, viable alternative protein sources are needed to be able to meet human nutritional needs for the rapidly increasing world population, while keeping food production within the planetary boundaries. T. molitor (Yellow Mealworm larvae) is a sustainably produced and commercially available edible insect, which contains a high quantity of protein with a favorable amino acid profile. Protein quality evaluation considers the amino acid composition as well as the ileal digestibility of the food's individual amino acids, to assess if human dietary requirements for essential amino acids can be met by the protein source. The present study will measure the digestibility of essential amino acids from T. molitor with a minimally invasive dual stable isotope tracer method that follows a plateau-fed test meal protocol. T. molitor will be intrinsically labelled with the stable isotope deuterium (2H), which will be given along with a reference amino acid mixture of known digestibility, labelled with the stable isotope carbon-13 (13C). Based on the results from the present study, protein quality of T. molitor as a protein source for human nutrition can be assessed, allowing a direct comparison of this novel protein source to other protein sources, such as meat and legumes.

NCT ID: NCT05860140 Active, not recruiting - Malnutrition Clinical Trials

Preventing Malnutrition Among Older Adults

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

This project aims to explore whether access to a digital education video can improve the nutritional situation of home-living older adults after being discharged from the hospital.

NCT ID: NCT05682781 Active, not recruiting - Malnutrition Clinical Trials

Nutrition Intervention in Older Adults at Risk of Malnutrition

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

Thailand is one of the fastest aging countries and older adults are at greater risk of having inadequate nutrient intake and malnutrition (undernutrition). In the community setting, malnutrition has been linked to low muscle mass, sarcopenia, increased incidence of disability and functional impairments. The objective of this prospective, multicenter, randomized controlled, open-label, parallel-design study is to determine the effects of an oral nutritional supplement with dietary counseling on body weight, in comparison with dietary counseling alone, in community dwelling older adults at risk of malnutrition.

NCT ID: NCT05571280 Active, not recruiting - Malnutrition, Child Clinical Trials

Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The severity of the stunting in the provinces of Huíla and Cunene, Angola, in children aged 6 to 59 months is considered to be very high, as defined by the World Health Organization (WHO) classification of 2018. Some of the strategies that present promising results in the fight against chronic malnutrition have been specific nutritional interventions and money transfers. Among these, those that have so far had a greater impact in reducing chronic malnutrition indicators are fortified foods and lipid-based nutrient supplementation in small amounts. The hypothesis of the study is that these interventions applied from pregnancy can significantly reduce chronic malnutrition, each of which may have different impacts. The study intends, therefore, to evaluate an intervention that aims to obtain the highest quality scientific evidence on the best package of sensitive and specific measures that reduce chronic malnutrition and mortality in children under 2 years of age, maintaining the fundamental premises of sustainability, cost-benefit ratio, and scalability for other regions of the country. To this end, it was designed a community trial randomized by clusters in which different strategies will be evaluated separately: - Standard Intervention (CONTROL Arm) The Standard package includes a series of actions carried out by Community and Health Development Agents (ADECOS), which are characterized by having demonstrated strong evidence of their effectiveness in the scientific literature, and are part of the WHO guidelines and national health guidelines in different countries, including Angola. - CONTROL+ NUT (Nutrients Arm): Standard Intervention plus nutritional supplementation - CONTROL+ TM (Money transfers Arm): Standard Intervention plus money transfers Study population: pregnant women with more than 16 years of age; however the target population of the interventions will be the household where the pregnant woman lives. The impacts of interventions on indicators of chronic malnutrition in children under 5 years of age belonging to the household will also be analyzed.

NCT ID: NCT05551819 Active, not recruiting - Malnutrition, Child Clinical Trials

Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition

Start date: October 26, 2022
Phase: N/A
Study type: Interventional

This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.

NCT ID: NCT05439174 Active, not recruiting - Clinical trials for End-stage Renal Disease

Impact of IDPN on Nutrition Markers in Patients Receiving ICHD

Start date: July 15, 2022
Phase:
Study type: Observational

Evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, and/or Clinolipid on albumin levels and weight in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis. Determine the average duration of time it takes for albumin levels to rise ≥0.2g/dL from the initiation of IDPN therapy as this has been associated with significant change in mortality and hospitalization risk. The investigators expect levels to rise significantly within 4-6 months, there may be a difference in outcome in patients receiving IDPN compounded with amino acids and dextrose only vs IDPN compounded with amino acids, lipid, and dextrose.

NCT ID: NCT05319717 Active, not recruiting - Clinical trials for Severe Acute Malnutrition

Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of treating children with severe acute malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or without rice bran.