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Malnutrition clinical trials

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NCT ID: NCT04109768 Withdrawn - Health Behavior Clinical Trials

Hands On Nutrition Education to Improve Childhood Health

Start date: March 31, 2020
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT04012333 Withdrawn - Critical Illness Clinical Trials

The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial

EFFORTcombo
Start date: June 2020
Phase: Phase 3
Study type: Interventional

The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional recovery as measured by 6-minute walk distance just prior to hospital discharge? The hypothesis: Compared to a control group reflective of usual care prescribing practices and an EN only approach, the administration of a higher dose protein/amino acids using EN and PN to nutritionally high-risk critically ill patients will be associated with improved functional outcome.

NCT ID: NCT03969199 Withdrawn - Malnutrition Clinical Trials

Give a MANNA a Fish, Teach a MANNA to Fish

Start date: December 2023
Phase: N/A
Study type: Interventional

This study is a randomized pilot seeking to address low patient adherence to a low sodium diet as a strategy to improve outcomes of patients with cirrhosis of the liver. In coordination with the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) of Philadelphia, patients in the intervention cohort will receive low sodium MANNA meals to encourage improved dietary compliance. Outcomes of these interventional patients will be compared to those receiving standard of care--namely, educational intervention by physicians supplemented by occasional counseling from dieticians during clinic visits encouraging a low sodium diet. Dietary compliance will be evaluated by urine sodium and salt affinity tests and used as a positive marker for improved outcomes. The target population of this study is patients diagnosed with cirrhosis of the liver, aged 18-85 years living within the MANNA-serviced area.

NCT ID: NCT03794154 Withdrawn - Healthy Clinical Trials

A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions

Start date: March 30, 2020
Phase: Phase 4
Study type: Interventional

In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively. The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30, or 60 mg of duloxetine, respectively. The purpose of this study is to verify through a single dose study, if the test formulation of duloxetine is bioequivalent to the reference formulation (Cymbalta®) when administered with the same dosage and under fed conditions in healthy male research subjects.

NCT ID: NCT03664141 Withdrawn - Hemodialysis Clinical Trials

Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)

ICON-HP
Start date: September 15, 2018
Phase: Phase 3
Study type: Interventional

The study will be performed in two parts: 1) The pharmacokinetic (PK) part and 2) The appetite and nutritional evaluation part. The PK part of study will be conducted in open label manner on 10 end stage kidney disease (ESKD) patients receiving maintenance hemodialysis (MHD) treatment. For the PK part, a starting dose of cannabis oil -1 drop of 3% cannabis oil once a day [each drop contain 1.2 mg CBD (cannabidiol) and 1.2 mg of ∆9-THC (∆9-tetrahydrocannabinol)], was judged to be safe for a first-in-MHD patient's administration. Escalation to the next higher dose and any dose adjustments of the next dose levels will be based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups. Once the first dosage proved to be safe, there will be a 2 fold increase from the first dose level (2 drops once a day) to the second dose level. The dose levels will be increased by 2-fold from the previous dose level, until basal hunger and prospective consumption ratings assessed by the visual analogue scale (VAS) will increase at least by 10 mm between screening and the study visits (change-from-baseline) . PK parameters will be evaluated after first dosage administration and after dosage increased. The appetite and nutritional evaluation part of study will be conducted as a 3-month, double-blind, parallel-group, placebo-controlled, single center study. The study population will include 30 ESKD patients receiving MHD treatment with different degrees of protein-energy wasting (PEW) defined as malnutrition-inflammation score (MIS) above 6. A total of 30 subjects will be randomized to treatment with either cannabis oil or matching placebo.

NCT ID: NCT03660540 Withdrawn - Sarcoma Clinical Trials

Spine and Tumor Screening and Supplementation

Start date: January 2021
Phase: N/A
Study type: Interventional

This project aims to evaluate an implementable screening tool and nutritional interventions that will lead to improved quality and patient safety. The aims of this pilot study are twofold: Purpose 1: assess the prognostic value of malnutrition and sarcopenia for identifying patients at increased risk of adverse postoperative outcomes following elective or semi-elective orthopedic procedures. Purpose 2: assess the clinical benefit of postoperative oral supplementation with a commercially-available nutritional supplement that includes conditionally-essential branched chain amino acids.

NCT ID: NCT03481894 Withdrawn - Malnutrition Clinical Trials

Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age

Start date: March 2018
Phase: Phase 4
Study type: Interventional

Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.

NCT ID: NCT03336021 Withdrawn - Clinical trials for Poverty, Low Income, Food Insecurity, Undernutrition

Impact Evaluation of Agribusiness Support and Nutrition Services Projects in Upper Egypt

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

This project seeks to evaluate the impact of two USAID-funded projects that are implemented in rural Upper Egypt. The first project is the Feed the Future Egypt, Food-Security and Agribusiness Support (FAS) project; the second project is the Improving Maternal, Child Health, and Nutrition Services (IMCHN) project. The specific study objectives are (1) to estimate the impact of FAS interventions on project outcome indicators—especially on household income (measured by total household expenditure), household food security, and maternal and child nutrition—among farm households; (2) to estimate the effects of IMCHN interventions on maternal and child health and nutrition knowledge among community health workers (CHWs) and among farm households; and (3) to analytically explore potential synergistic effects of FAS and IMCHN interventions on maternal and child nutrition among farm households being exposed to both projects.

NCT ID: NCT03176030 Withdrawn - Aging Clinical Trials

Fortified Foods in Older Inpatients

Start date: September 1, 2017
Phase:
Study type: Observational

Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.

NCT ID: NCT03166371 Withdrawn - Malnutrition Clinical Trials

Glutathione (GSH) Supplementation After Hospitalization

Start date: February 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to see if oral liquid glutathione treatment, has any effect on improving health-related cellular protection, muscle size and strength, and fatigue, weakness, and quality of life in older adults with a history of malnutrition who have been hospitalized. Persons enrolled in this study will be those initially admitted to Emory University Hospital (EUH) in Atlanta, GA, but recovering and ready to be discharged home or to an assisted living facility to eat an oral diet. A combination of nutritional measures, blood markers and imaging tools will assess body composition. Study participants will complete questionnaires about quality of life and physical health, and do simple testing for physical strength and stamina. Information from this pilot study will increase understanding of a simple intervention which may prevent or reduce health risks related to hospital recovery in older adults.