33 Clinical Trials for Various Conditions
This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver.
Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes. The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.
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.
Purpose: The purpose of this study is to determine whether implementation of an educational tool for nutritional concerns in 18-25-year-old females who participate in sport increases their understanding of various nutritional concerns. By studying an educational tool geared towards nutritional concerns of the female athlete, clinicians can use the information to improve clinical practice and patient outcomes. Procedure: Participants will be asked to complete a previously validated survey assessing knowledge of nutritional concerns of female athletes: the Female Athlete Triad, Relative Energy Deficiency in Sport, and eating disorders. The survey will be completed immediately pre- and post-receipt of the educational intervention. The intervention includes education on the previously mentioned nutritional concerns.
The objective of this study is to compare the quantity of Zn absorbed from an accurately weighed quantity (\~100 g) of minimally milled control maize (\~15 µg Zn/g maize), from biofortified maize (\~30 µg Zn/g) and from the same control maize that has been fortified (total level of \~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual food staple is maize.
Bioavailability of iron and zinc from habitual plant-based diets consumed by young children in Mexico is low due to the high phytate content. Whey protein has been found to increase zinc absorption, thus, providing a whey based supplement with micronutrients may be an effective strategy to increase iron and zinc bioavailability from plant-based foods and alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron in children receiving diets with and without whey protein supplements (WPS).
Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this diet might play a role in these processes. Supplementation of this micronutrient in the diet might be beneficial. The investigators will compare absorption of Zn from white maize tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool children in Guatemala.
Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron absorbed are measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets.
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.
Insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. One of these factors may be a deficient magnesium status. This study will look at whether or not magnesium supplementation will improve sleep.
Inadequate feeding of infants and toddlers impairs physical and cognitive development and is a major contributor to early childhood infectious disease illnesses and preventable mortality. Optimal feeding has two broad components: Exclusive breast feeding (EBF) for the first-6 months followed by continued breast feeding accompanied by complementary foods (CF) that is adequate in quantity and quality. While EBF is theoretically straightforward, CF is more complex. This is because CF is typically limited mainly or entirely to plant-based foods in developing countries worldwide. Dependence on adequate, affordable locally-produced foods for complete CF requires an inexpensive, regular source of meat especially to provide 'problem' micronutrients, notably, but not only, zinc and bioavailable iron. While the use of micronutrient-fortified CF and of supplements, including SprinklesTM, is spreading, their efficacy largely remains uncertain as does their availability, particularly on a sustainable, affordable basis Achievement of the widespread regular use of meat as a CF requires: (1) adequate local production of affordable small scavenging/foraging animals in poor rural and, where feasible, periurban communities worldwide; (2) effective communication for behavioral change/education so that young children, starting at age 6 months (when meat is readily accepted by infants), receive priority in the use of this meat. Solid scientific evidence of the value of international/national programs to achieve this goal is essential to provide the basis and incentive for major international and national programs to promote the feeding of meat as an early and regular CF. The acquisition of such evidence is the goal of this study The intervention to be evaluated is meat fed daily as a complementary food from age 6-18 months. Thirty infants-toddlers in each of 60 rural communities (total of 1,800 subjects) will participate. In a cluster design, twenty communities (test) will be randomized to receive meat,twenty communities (control) will receive a plant recipe providing the same amount of calories, twenty communities (fortified cereal) will receive a commercially available fortified cereal providing the same amount of calories. This project will be located in rural China in a county where high quality collaboration is already established, and where we have recently demonstrated inadequate bioavailable zinc intake and zinc deficiency in toddlers. We have also found a high (30%) incidence of stunting, now widely used as an indirect indicator of populations with zinc deficiency. Other advantages of this location include the willingness of doctors located in each rural community to provide the test or control meal 7 days per week in their homes and the absence of any access to supplements / fortified products which could complicate interpretation of data. The young children in the test communities will receive certified safe lean pork 7 days per wk. Starting with a very small quantity at 6 months, the quantity of lean pork will be increased as infants are ready to take more up to a plateau of 2 oz/d. No subsequent increases are planned because neither zinc nor iron requirements increase from 6-11 months to 12-18 months. Lean pork will be used because pigs are ubiquitous in China and can be maintained cheaply by scavenging/foraging on waste materials adjacent to human habitation. Test and control clusters will also receive nutrition education to achieve maximal diversification of locally available affordable foods. Longitudinal outcome measures include indices of physical growth, especially length; infectious disease incidence and prevalence; cognitive development; zinc and iron intake and biomarkers for these and other micronutrients. Zinc absorption will be measured. Data will flow daily from communities to the district hospital in Xi-Chou, weekly to the data manager in Shanghai and 3-monthly to the Data Monitoring Safety Board (DSMB) and to the University of Colorado research group.
The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are: * Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake? * Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections? Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.
The goal of this research study is to develop a nutrition algorithm to optimize nutritional status and improve quality of life during for participants who are completing or have completed cancer treatment. The name of the intervention used in this research study is: Nutrition Algorithm for Cancer Health Outcomes (NACHO) (a technology-based platform that houses the algorithms for the person-centered nutrition program)
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.
In preparation for a future mechanistic study, investigators now propose to test the specific hypothesis that carnitine consumption is not reduced in PAH, that plasma carnitine levels are stable over time in PAH and that carnitine supplementation in PAH can increase plasma carnitine and thereby delivery of carnitine to the RV and possibly improve RV function. Investigators propose three aims in humans to test this mechanistic hypothesis, 1) Measure the oral consumption of carnitine in human PAH. This aim will use food diaries and carnitine supplement use questionnaires in PAH patients to test the hypothesis that carnitine supplementation is uncommon in PAH and food consumption is adequate. Aim 2) Measure the stability over time in plasma carnitine levels in PAH patients. This aim will test the hypothesis that plasma carnitine is not affected by disease severity and is stable over time in PAH patients. Investigators will measure plasma carnitine concentration and markers of fatty acid oxidation at Visit 1 and Visit 2. 3) Perform a mechanistic pilot study using carnitine supplementation to enhance circulating carnitine in PAH. This small pilot study will test the hypothesis that carnitine supplementation increases plasma carnitine (primary endpoint) and will test for physiologic effects using six minute walk testing, echocardiography and plasma markers of lipid metabolism.
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (\<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.
This study is to assess the usability and acceptability of a digital food consumption diary as part of the perioperative management of gastrointestinal oncology patients and to evaluate the impact of a digital food diary on adherence to dietician-recommended plan and on quality recovery, using a commercially available smart phone application.
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.
The purpose of the proposed study is twofold: 1) The investigators will evaluate ultrasound imaging to screen trauma patients to identify patients at increased risk of postoperative complications associated with sarcopenia. 2) The investigators will evaluate a commercially-available oral nutritional supplement that has previously been evaluated in critically-ill intensive care patients and shown benefit for decreasing complications including decreased wound healing complications, decreased pressure ulcers, decreased skeletal muscle loss due to immobilization, and decreased one-year mortality.
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.
The investigators are studying how to prevent malnutrition in children with sickle cell disease (SCD) in northern Nigeria. Community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. The investigators will enroll 148 children with SCD aged 6 to 18 months old. The investigators will determine if their weight and diet improve and check for low vitamin A levels. This information will help us find better ways to improve growth for children with SCD.
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.
This study is a randomized, controlled, double-blinded single center trial to compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency anemia (IDA) in infants and young children. Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin concentration during a twelve week course of treatment to subjects with iron deficiency anemia. Primary Aim: To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional IDA in infants and young children as determined by increase in hemoglobin concentration. Secondary Aims: 1. To compare the adverse effects of treatment for IDA between ferrous sulfate and NovaFerrum® 2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous sulfate or NovaFerrum® 3. To compare the adherence to study medication between subjects on ferrous sulfate and NovaFerrum® 4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional IDA
Iron deficiency anemia (IDA) affects nearly half a million young children in the United States. Most children take liquid iron medicine by mouth for at least 3 months. However, some children take longer to get better with this medicine. This study is trying to compare different ways of giving iron medicine to young children. For young children in the US, the main cause of IDA is nutritional, or not having enough iron in the foods they eat. This often happens when kids drink too much cow milk and/or not eating enough foods that have a lot of iron. Iron deficiency is most common in children ages 1 to 4 years of age, during a time that is important for brain development. More severe and long-lasting IDA is associated with worse brain development outcomes. That is why researchers want to understand the fastest way for kids with IDA to get better. Standard treatment is oral iron medicine for 3 to 6 months. Many children do not take their iron medicine the full amount of time needed because of side effects like abdominal discomfort, nausea, constipation, and bad taste. Different factors can contribute to patients not completing their IDA therapy. Many families do not understand how important it is to treat IDA or do not have the motivation to continue the medication. This study will offer different methods for treating IDA, including a different method to taking the oral iron therapy. This new method gives oral iron by increasing a family's understanding and motivation. Another research study that interviewed families of young children with IDA found ways that helped the patients to continue their therapy. Using that information, a website called IRONCHILD was created to help motivate parents to get their children to continue the oral iron medicine. Research studies that compare these different IDA treatment methods in young children are needed and could have benefits to short-term clinical and long-term brain development. However, we do not know whether families of young children with IDA will be willing to participate in this type of study that has different treatment methods (oral iron therapy and oral iron therapy with a web-based adherence intervention). The goal of this clinical research study is to learn which of the two methods of care will be the best way for children with iron deficiency anemia to receive therapy.
This study establishes the safety and efficacy of vit A supplementation doses (3000 and 6000 IU/d) over 8 weeks in children with SCD-SS, ages 9 and older and test the impact of vit A supplementation on key functional and clinical outcomes. Additionally, vitamin A status is assessed in healthy children ages 9 and older to compare to subjects with SCD-SS.
Many older adults do not get enough zinc, vitamin C and vitamin D, and this can be related to decreased ability to fight infection. The purpose of this research study is to determine if taking a multivitamin/mineral supplement every day for 12 weeks will increase the ability of immune cells in blood to kill bacteria.
The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks of treatment, and long-term effects will be evaluated over the duration of a 48 week treatment period.
Vitamin D (Vitamin D) deficiency is very common. We recently showed that 97% of 204 patients admitted to Truman Medical Center were Vitamin D deficient (\<30 ng/ml). However, the consequences of Vitamin D deficiency, particularly with respect to infection, are not well understood. It is known that production of cathelicidin, an important antimicrobial peptide, is critically dependent upon Vitamin D. It is also established that levels of cathelicidin correlate inversely with urinary tract infection risk. We hypothesize that restoration of Vitamin D levels to normal in patients undergoing major surgery will result in significant decreases in levels of perioperative infections due to restoration of normal levels of circulating Vitamin D, which in turn will elevate cathelicidin levels. As an initial test of this hypothesis, we propose a double-blind, prospective, randomized study of pre-operative Vitamin D supplementation. Fifty subjects undergoing surgery will receive daily Vitamin D3 (50,000 IU) for five days pre-operatively, with controls receiving placebo. Levels of Vitamin D, calcium, cathelicidin, and the pro-inflammatory protein resistin, will be monitored before Vitamin D supplementation (pre-operatively) and after Vitamin D supplementation (post-operative days 1 and 2). The effect of these changes should be to decrease the incidence of infectious complications. We expect to observe Vitamin D levels increase to normal, and cathelicidin levels become elevated. We expect to see increased levels of resistin in patients developing infections. This study will provide strong pilot evidence for future NIH funding.
The purpose of this study is to determine if the vitamin D binding protein genotype influences circulating vitamin D levels and if it may have functional consequences on vitamin D activity.
The purpose of this study is to determine whether a 30 day beef intervention can improve peak cognitive performance in young, normally menstruating adult women. The control group will consume a daily portion of macronutrient equivalent vegetable source of protein.