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Showing 1-20 of 967 trials
NCT06433310
The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.
NCT05932329
This randomised controlled trial aims to assess the effects of three different types of dietary advice for reducing free sugar intakes, on intakes of free sugar, in a sample of the UK population.
NCT01237093
Background: \- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they ate. One possible method involves the use of biomarkers, or indicators in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food in a consistent way. One set of biomarkers in blood samples and hair may be used to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However, more research is needed to study the effectiveness of using these biomarkers to accurately track dietary intake. Objectives: \- To validate the use of biomarkers as representative of specific dietary intake patterns (meat/fish/soda). Eligibility: \- Healthy, nondiabetic men between 18 and 65 years of age. Design: * This study involves an initial screening visit and a 12-13 week inpatient dietary study period. * Participants will be screened with a medical history and physical examination, as well as blood and urine samples and a glucose tolerance test to exclude individuals who have diabetes. * After 3 days of a standard weight-maintaining diet, participants will have a glucose tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and complete questionnaires and performance tests. * Participants will spend one day in a metabolic chamber to measure their energy expenditure and general metabolism. * Participants will then be randomized into one of eight carefully designed diets for 12 weeks. The diets will differ in the amount of meat, fish, and soda, including one diet where none of the three biomarker-related foods will be permitted. Blood samples will be collected throughout the study diet period. * At the end of the 12-week study diet period, participants will provide additional hair, blood, and fat tissue samples, and will have a second metabolism assessment in the metabolic chamber.
NCT07639411
The aim of this prospective, randomized, single-group interventional study is to use quantitative methods to investigate the acute effects of using lateral-wedge insoles on lower extremity biomechanics, muscle activation patterns, and knee adduction moment during walking and running activities in healthy individuals aged 18-40. The primary research questions it seeks to answer are as follows: * Do lateral wedge insoles cause a significant change in knee adduction moment? * Do lateral wedge insoles change lower extremity biomechanics during walking and running? * Do lateral wedge insoles change the activation patterns of lower extremity muscles during walking and running? To compare the effectiveness of lateral wedge insoles, participants will randomly use insoles with 0 (neutral), 5, and 10-degree angles. Participants will do the following: * Put on the shoes and insoles provided to you in the motion analysis laboratory and complete the walking and running protocols, each taking 1 minute, on the treadmill. * While walking at your normal walking speed, step so that your dominant leg is positioned over the force plate. * Repeat all of this for the insoles at the other two angles.
NCT07619976
New Zealand blackcurrant (NZBC) is a supplement made from a berry naturally rich in plant compounds called anthocyanins. Researchers have studied these compounds for years and found that they may help the body by improving blood flow, reducing post-exercise stress on the body, and supporting energy production. Most of that research, however, has focused on endurance athletes like runners and cyclists. Almost nothing was known about whether NZBC could benefit people who do strength training. That is what this study was designed to find out. Twenty healthy, resistance-trained men and women between the ages of 18 and 40 were recruited. Each participant completed four different conditions over the course of the study: taking no supplement at all, taking a placebo (a dummy capsule with no active ingredient), taking a low dose of NZBC (250 mg per day for seven days), and taking a higher dose of NZBC (600 mg per day for seven days). Neither the participants nor the researchers evaluating them knew which capsule was being taken at any given time, a design that helps ensure the results are as reliable as possible. At the end of each seven-day period, participants came into the lab and completed a full battery of tests. Measurements included how much weight could be lifted for one maximum effort on the bench press and leg press, how much total volume could be completed across multiple sets, and how fast and powerfully the bar could be moved. Participants also completed a 30-second all-out cycling sprint to test anaerobic fitness, and a paper-and-pencil color-word test to measure focus and mental sharpness. Strength increased noticeably. After taking either dose of NZBC, participants were able to lift more weight on both the bench press and leg press than when taking the placebo or no supplement. The lower dose had a particularly striking effect on leg training: participants pushed through roughly 38% more total volume in their leg press sets. For bar speed and explosive power on the bench press, the higher dose had the edge. Cognitive performance followed a similar pattern. The lower dose sharpened mental performance across several parts of the color-word test, while the higher dose made a more modest but still meaningful difference on one section. The sprint cycling test showed no differences between conditions. Importantly, both doses were safe and well-tolerated, with no meaningful side effects reported throughout the study. One week of supplementation was sufficient to produce real differences in strength, power, and mental sharpness, and neither dose raised any safety concerns.
NCT07612852
The DELPHI project (Digital Engagement for Lifelong Prevention and Health Improvement) aims to develop, implement, and validate an advanced digital platform for promoting well-being and personalized prevention of chronic non-communicable diseases in healthy adults. By integrating wearable sensors, artificial intelligence, federated learning, and the Human Digital Twin (HDT) paradigm, the DELPHI platform is designed to collect, analyze, and interpret multidimensional data in order to deliver dynamic and personalized recommendations for healthy lifestyles. The study adopts a multicenter, randomized controlled pilot design, with a maximum duration of 12 months per participant. A total of 200 healthy adults aged 18-65 will be recruited in Southern Italy (Sicily, Campania, and Basilicata) and randomly assigned to either: (1) an experimental group using the full DELPHI platform, including personalized recommendations, adaptive content, and continuous feedback; or (2) a control group using a basic version limited to passive monitoring. As a non-clinical primary prevention pilot study, DELPHI aims to assess the operational feasibility, usability, and acceptability of the platform in real-world settings, while also exploring preliminary signals of impact on health and lifestyle domains without confirmatory purposes. Secondary objectives include monitoring physiological indicators, adherence to the app and wearable devices, and evaluating the feasibility of implementing the platform in workplace environments. Data collection will rely on wearable devices, digital questionnaires, and behavioral analysis, with strong safeguards for personal data protection in compliance with GDPR and advanced security approaches such as federated learning and encryption. Specific subgroups, including workers from the Fondazione Don Carlo Gnocchi (FDG) as well as university staff and students, will be involved in targeted assessments related to mental well-being and distress. In addition, workers from the FDG will test a virtual reality module designed to evaluate biomechanical overload risks during manual handling activities in simulated environments. These additional physiological and virtual reality components are exploratory and non-diagnostic. Overall, DELPHI seeks to provide a solid foundation for the adoption of predictive and personalized models in digital health, contributing to the development of a sustainable and accessible prevention ecosystem, particularly in Southern Italy.
NCT02504853
Background: \- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them. Objective: \- To learn more about the causes and effects of food allergy and related conditions. Eligibility: * People ages 2 99 who have food allergy and/or a related genetic or other condition * Their relatives * Healthy relatives and volunteers Design: * Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer. * Participants will be screened with medical history, physical exam, and questionnaires. * Participants may have the following: * Blood tests * Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop. * Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm. * X-rays * Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour. * EGD and colonoscopy: Biopsies are taken from the gastrointestinal system. * Tiny biopsies of skin * Photographs of the body * Collection of cells through: * Swab of nose, inside of cheek, or skin * Gentle skin scrape * Tape stripping: piece of tape is put on the skin and pulled off.
NCT04447209
The 2019-2020 coronavirus pandemic has had far-reaching consequences beyond the spread of the disease. Quarantine measures during a public health pandemic can be particularly detrimental to urban poor families and affect the dietary diversity and food security. This can disproportionately affect young children aged 6 and below, and severely impact those \<2 years. Sudden unemployment may result in an unexpected reduction in income that will place pressure on daily budgets for food. Children of families may not have access to foods of adequate diversity that will enable them to meet their macro and micronutrient requirements for growth and development, especially during the Movement Control Order (MCO). The study plans to monitor and evaluate dietary diversity in young children's food intake after the MCO and use the collected information to direct targeted food aid to address observed macro- and micronutrient deficiencies among the urban vulnerable group.
NCT07597811
This study aims to evaluate the impact of a community-based nutritional intervention based on the Planetary Health Diet on dietary patterns, gut microbiota composition, and health indicators in adult women living in rural communities in Querétaro, Mexico. Participants will receive nutritional education, individualized counseling, and practical workshops focused on improving dietary habits and promoting sustainable food choices. The intervention is designed using behavioral and community-based approaches to facilitate long-term adherence to healthy and environmentally sustainable diets. Outcomes will be assessed before and after the intervention, including changes in diet quality, anthropometric measures, gut microbiota composition, and environmental impact indicators such as carbon footprint, water use, and land use.
NCT07568574
Objectives: The primary objective is to assess the safety and tolerability of medical drugs with the potential to enhance performance (PES) in professional athletes over a 5.5 year period, encompassing a 25-week PES Exposure period and 5 year long term follow-up of period comprehensive health and safety monitoring. The secondary objective is to evaluate the impact of PES on athletic performance through validated sport specific and clinical assessments. Methods: This prospective hybrid design study will enrol 60 adult participants, divided into two groups. The first group will receive performance-enhancing substances (PES) directly through the study, administered as Investigational Medicinal Products (IMPs) under comprehensive medical supervision for up to 25 weeks. The second group will include natural athletes and those already using PES prescribed by their own doctors. All substances used in this study are medically approved by national regulatory agencies (e.g., FDA, MHRA, EMA, EDE, etc.), and market authorised. Participants undergo enrollment and baseline health and performance assessments, prior to a 25 weeks of PES exposure. During the period of PES exposure, participants undergo periodic monitoring of comprehensive physiological biomarkers alongside subjective assessments. Following the PES exposure phase, participants will complete repeat baseline health and performance assessments, followed by a titration phase and, where indicated, post-cycle therapy (PCT) to support the restoration of physiological function toward baseline. The study will conclude with a five-year longitudinal follow-up period to monitor long-term health outcomes. During this phase, participants will undergo annual assessments, including cardiac electrocardiography (ECG), echocardiography, magnetic resonance imaging (MRI), blood and urine biomarkers, routine vital signs, and quality-of-life measures. Additional imaging will include brain functional MRI (fMRI) and vital organ ultrasound at years 1, 3, and 5, with cardiac CT performed as clinically indicated. Athlete safety biomarker assessments, clinical evaluations, and adverse event reporting, will be continuously evaluated by study doctors and with additional safety oversight from a Data Safety Monitoring Board, Independent Medical Commission (a multidisciplinary panel of medical experts), and a Medical Monitor.
NCT05291741
To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.
NCT07386730
This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)
NCT07188389
This study aims to examine the effects of acute aerobic exercise and cardiorespiratory fitness on cellular metabolism of CD8+ T cells and regulatory T cells (Tregs) found in the peripheral blood of humans. In addition, the study will investigate whether the effects of exercise differ based on exercise intensity, as well as whether the effects of exercise and fitness differ between subpopulations of CD8+ T cells and Tregs. Finally, the study aims to examine whether exercise- and fitness-induced changes in cell metabolism relate to changes in cell function.
NCT06734468
The goal of this clinical trial study is to evaluate the impact of a personalized lifestyle intervention on improving healthspan. The primary questions of interest are whether the personalized intervention will result in improvements in muscle function, immune function, and cognitive function in adults aged 50-85 years. Participants will complete baseline assessments, receive an individualized intervention plan for approximately 3 months, and then complete post-intervention assessments. The intervention includes an exercise plan, nutrition recommendations, and general lifestyle goals that will be personalized to each participant.
NCT06015646
The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.
NCT05127109
This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.
NCT07244458
This study will look at how eating peanuts every day might affect participants weight, how healthy their diet is, and how they feel when eating. Investigators want to see if adding peanuts to meals for 12 weeks helps participants feel fuller, have more energy, and improve body composition. The study will include adults who have been taking GLP-1 medicines like semaglutide or tirzepatide for at least three months. Investigators also want to see if eating peanuts improves overall diet quality and health markers like tiredness and certain levels in blood.
NCT07437248
This study aims to understand how much leucine, an essential amino acid, and protein building block, healthy pregnant women need during early and late pregnancy. Leucine plays an important role in supporting muscle health and fetal growth. Participants will consume carefully prepared meals and provide breath, urine samples, and one blood sample so researchers can measure how the body uses leucine at different stages of pregnancy. The results will help improve nutrition guidelines for pregnant women to better support maternal health and healthy fetal development.
NCT07160530
The purpose of this study is to find out whether a program called "Healthy Children, Healthy Communities" can help young children in rural areas eat healthier and improve their health. The study focuses on children ages 3 to 5 who attend family childcare homes in rural communities. The main goal is to see if the program can: Help children eat healthier foods, like more fruits and vegetables. Support childcare providers in using positive mealtime practices that encourage healthy eating. The study will involve about 120 licensed family childcare providers in rural areas who participate in the Child and Adult Care Food Program (CACFP), along with about 240 children they care for. Childcare providers will be randomly placed into one of two groups: EAT Family Style Group (Intervention Group): Complete 7 online training modules over 16 weeks about healthy mealtime practices. Join 7 individual coaching sessions on Zoom. Record short videos of their mealtimes to get personalized feedback from a coach. Work with a coach to set goals and make plans to improve mealtimes. Receive printed materials and conversation cards to use during meals. Some providers may join Zoom interviews to share their experiences. Better Kid Care Group (Comparison Group): Complete 10 online modules about general childcare topics like child development, oral health, play, and managing a childcare home. For both groups, the research team will: Ask providers to fill out online surveys about how mealtimes work in their childcare homes. Visit the childcare homes to observe and record children's mealtimes on two days at each data collection point. Measure the height and weight of participating children. Use a painless skin scanner (Veggie Meter) to check how many fruits and vegetables children have been eating. Ask providers to complete surveys about the children's eating habits. The study focuses on rural, low-income communities, where children are at higher risk of having poor diets and obesity compared to children in urban areas. Information will be collected at the start of the study, after 16 weeks, and again after 24 weeks to see if there are lasting changes.
NCT07533877
This randomized controlled online experiment will test whether adding an ultra-processed food (UPF) warning label to the FDA's proposed Nutrition Information Box (NIB) changes consumer perceptions of UPFs among a nationally representative sample of U.S. adults. Participants will be randomized to one of four label conditions and will evaluate four UPF yogurt products with different nutritional profiles on the NIB. The primary outcome is purchase intent and the secondary outcomes are perceived healthfulness, perceived usefulness and correct identification of UPF products. This experiment aims to answer the following questions: Do UPF warning labels reduce purchase intentions compared to the NIB alone? Do UPF warning labels reduce perceived healthfulness compared to the NIB alone? Do UPF warning labels help more consumers correctly identify products as ultra-processed compared to the NIB alone? Do different UPF warning label color designs differ in effectiveness at reducing purchase intentions, lowering perceived healthfulness, and improving correct identification of UPFs? Researchers will compare outcomes across the four randomized arms to estimate the independent effect of adding UPF warnings beyond nutrient disclosure in the NIB alone.