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Malnutrition clinical trials

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NCT ID: NCT04448041 Completed - Cancer Clinical Trials

CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries

CRANE
Start date: September 7, 2020
Phase:
Study type: Observational

Aims: The CRANE feasibility study (A mixed methods study of malnutrition and sustainable nutritional intervention for patients undergoing cancer surgery in low- and middle-income countries) aims to investigate the identification of pre-operative malnourishment, data collection methods and acceptability of a nutritional intervention for a future trial to improve outcomes after cancer surgery in low- and middle-income countries (LMICs). 1. To identify and validate the most relevant nutritional screening tool for patients in LMICs undergoing surgery for cancer; 2. To identify a low cost sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer; 3. To establish the feasibility of delivering a randomised trial of a sustainable nutritional intervention for patients in LMICs undergoing surgery for cancer. Design: A mixed-methods study comprising of qualitative work including focus groups and interviews, trial of data collection and validation to test feasibility in clinical practice Participants: Patients undergoing elective surgery for suspected cancer in LMICs Outcomes Work package (WP) 1: The primary deliverable is the identification of a relevant, pragmatic, and acceptable nutritional screening tool. WP 2: The primary deliverable is the identification of a low-cost and sustainable nutritional intervention. Focus groups and interviews will be held with patients and clinicians to explore the sustainability, implementation and acceptability of screening and interventions. WP 3: The primary outcome will be to determine feasibility and acceptability of trial design. A number of outcome assessments and data collection instruments will be evaluated for feasibility, including anthropometric parameters and patient outcomes (30-day mortality, major post-operative complications, length of hospital stay and quality of life). A final study design, analysis plan, and health economic plan will be developed. Sample size: For this feasibility study, the investigators will conduct multidisciplinary focus groups and interviews, perform and validate malnutrition screening in 200 patients across four countries and record patient 30-day outcomes. This will also include the time taken to collect data on 200 eligible patients. This sample size has been informed from previous malnutrition data originating from a large prospective international multicentre observational cancer study (GlobalSurg 3).

NCT ID: NCT04421755 Completed - Hypertension Clinical Trials

The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure

Start date: July 16, 2019
Phase: N/A
Study type: Interventional

Hypertension and diabetes, which are increasing in prevalence, contribute to significant morbidity and mortality in the U.S. Self-management of these diseases, including adherence to dietary guidelines such as daily fruit and vegetable intake, can improve outcomes, but low-income patients encounter many barriers to adherence, such as food insecurity and poor nutrition literacy. Few clinicians screen for food insecurity, and even when screening is performed, there are few tested clinical response models. This study will evaluate the benefits of fresh fruit and vegetable home delivery program, without and with small-group culinary medicine cooking classes, on blood pressure and glucose control among patients accessing care at the University of Oklahoma Internal Medicine Clinic in Tulsa, OK. The Produce Drop pilot study will evaluate the feasibility and potential health benefits of a clinic-community partnership between OU Internal Medicine and a fresh produce home-delivery service provider, to promote adherence to F/V dietary guidelines among patients with suboptimal blood pressure and blood glucose control. Among half of those assigned to receive food assistance, we will evaluate the additional benefits of participation in 3-session, small-group, hands-on culinary medicine curriculum.

NCT ID: NCT04411953 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions

Start date: November 15, 2019
Phase: Phase 1
Study type: Interventional

The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan Pharmaceuticals Inc.) are bioequivalent under fed conditions.

NCT ID: NCT04401930 Completed - Aging Clinical Trials

Eating Habits and Lifestyle Profile of an Italian Aging Cohort

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

Aging is characterized by low-grade inflammatory state, supported by impairment oxidative balance and endocrine changes, leading to changes in: body composition, such as decrease in lean body mass and increase in adipose tissue; resting metabolic rate; immune function; cognitive impairment. According to the Academy of Nutrition and Dietetics all subjects over the age of 60 should be able to access to adequate nutrition and appropriate nutritional services. In order to ensure healthy aging and to reduce effects of specific diseases, recommendations are needed for illness and disability in this population, as well as adequate physical activity and specific support programs, culturally accepted. The aim of this study is to evaluate eating habits in term of food consumption, health state and lifestyle in a sample of free-living elderly over the age of 65, living in Milan and surroundings. In particular, profiling of the elderly population is performed using a survey in which information are collected on methods, contexts, time and ability to buy, prepare, consume and dispose of and recycle food. Eating habits and knowledge about food are detected through the analysis of food consumption frequencies, and lifestyle by assessing the level of physical activity, quality of sleep, smoking habit. Weight status and health status are evaluated through anthropometric measurements, body composition (bioelectrical impedance) and strength test. Other information relating to social participation and other socio-demographic variables (age, gender, family composition, socio-economic status) are collected to have a completed profiling of target population. Achieved results will help us to identify factors on which acting to ensure healthy aging and counteract inflammaging, the chronic low-grade systemic inflammation characteristic in the aging process. Moreover, the study allows increasing the knowledge related to the needs and requirements of the target population to determine a good food policy and to increase the elderly empowerment.

NCT ID: NCT04393909 Completed - Asthma Clinical Trials

Improving Safety of Diagnosis and Therapy in the Inpatient Setting

PSLL2-0
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly analyze the problem, design and develop potential solutions that leverage existing current technological infrastructure, and implement and evaluate the final interventions. The investigators will engage the interdisciplinary care team and patient (or their caregivers) to ensure treatment trajectories match the anticipated course for working diagnoses (or symptoms), and whether they are in line with patient and clinician expectations. The investigators will use an Interrupted time series (ITS) design to assess impact on diagnostic errors that lead to patient harm. The investigators will perform quantitative and qualitative evaluations using implementation science principles to understand if the interventions worked, and why or why not.

NCT ID: NCT04352530 Completed - Obesity Clinical Trials

Culturally Appropriate Nutrition Communication for Mexican American Women

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

NCT ID: NCT04351828 Completed - Quality of Life Clinical Trials

Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease

Start date: November 5, 2018
Phase:
Study type: Observational

Celiac disease is defined as an autoimmune enteropathy with malabsorption of gluten protein. In recent studies, it has been stated that in individuals diagnosed with celiac disease, intestinal epithelial barrier integrity is impaired. Increased zonulin concentration in blood is considered as an indicator of increased intestinal permeability. Gluten-free diet is the only treatment of celiac disease. Adherence to gluten free diet provides decreasing of intestinal permeability however gluten free diet has different aspects on nutritional status and health related quality of life in people with celiac disease. The aim of this study is to determine nutritional status, intestinal permeability and quality of life in people with celiac disease. In the study,it primarily hypothesized that celiac patients noncompliant to gluten-free diet may have increased circulating levels of zonulin and increased intestinal permeability compared to celiac patients compliant to gluten-free diet.

NCT ID: NCT04345874 Completed - Health Behavior Clinical Trials

Virtual Technical Assistance for Child and Adult Care Food Program in Family Child Care Home

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effect of a fully virtual nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Half the providers will be randomly assigned to the nutrition program and the other half will receive a comparison on environmental health.

NCT ID: NCT04336540 Completed - Obesity Clinical Trials

Increasing Availability of Lower Energy Meals vs. Menu Energy Labelling on Food Choice

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Two randomized control trials examining human food choice (i.e. selection of high energy 'unhealthy' foods vs. selection of healthier foods). Interventions: In a between-subjects design, participants (recruitment stratified by socioeconomic position) made food choices (main dish, plus optional sides and desserts) in the absence vs. presence of menu energy labelling and from menus with baseline (10%) vs. increased availability (50%) of lower energy main dishes. Main outcome measures: Average energy content (kcal) of main dish chosen and average total energy content of all food ordered, including optional sides and desserts.

NCT ID: NCT04334538 Completed - Malnutrition, Child Clinical Trials

Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.