94 Clinical Trials for Various Conditions
The purpose of this study is to determine the effects of meat on inflammatory and metabolite profiles in middle-aged individuals after an acute meal. Up to 36 adults, who are overweight or obese and between 30-60 years old will undergo a consent/screening visit, followed by three study visits. On separate visits to the clinical research facilities at the Center for Human Nutrition Studies, participants will consume either 9 oz (250 grams) of cooked grain-fed beef, grass-fed beef, or a plant-based meat alternative (Impossible Burger). Blood will be drawn prior to food consumption and three more times after eating the meal at 1h, 3h, and 5h after participants finishing their meal. The investigators will use those blood samples to determine the impacts of these foods on inflammatory markers and metabolite profiles (compounds that circulate in our blood such as amino acids, fatty acids, and phenolics).
This study plans to learn more about how consuming a diet with foods typical to a Mediterranean Diet such as whole grains, fruits and vegetables in a Western-style diet compares to eating a typical Western-style diet. This study will look at how diet affects overall health including risk factors for heart disease, gut health and inflammation as well as underlying mechanisms linking whole food to health. Findings from this study will potentially inform effective dietary recommendations and interventions, thereby reducing chronic disease in humans.
This is an R01 funded project that focuses on the utility of metabolomics as a biomarker for OSA. Aims 1 and 3 leverages banked samples previously collected from subjects with and without OSA at the University of Pennsylvania and University of Iceland. Aim 2 is a prospective study that will collect serum samples from OSA subjects at the University of Pennsylvania and the University of Iceland.
The purpose of this study is to find out if combining a state-of-the-art form imaging modality with metabolomics in different types of Interstitial Lung Diseases (ILD) patients compared to controls with chronic obstructive pulmonary disorder (COPD)/emphysema and healthy controls will be a better predictor of disease progression. ILD's are a group of chronic, progressive lung diseases. The most common ILD is idiopathic pulmonary fibrosis (IPF). Metabolomics provides a "snapshot" in time of all metabolites present in a biological sample. The imaging procedure should take approximately 20 minutes. All study related collections of samples will be done in a single visit if possible. There are no direct benefits to participants. This is not a treatment study.
Objectives: The aim of the present study is to assess the significance of metabolomics and genetics in diagnosing and survival evaluation for pNET in the periodic follow-up of MEN1 patients. Aim 1: To evaluate the relationship of serum global metabolic profiles with subsequent development of aggressive PNET and evaluate patients survival in a nested case-control study of MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls). Aim 2: Validate the top serum metabolites identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and MEN1 patients who have developed non-aggressive PNETs, using a targeted metabolomics approach. Aim 3: Prospectively identify the potential miRNA biomarkers of serum with miRNA sequencing in MEN1 patients who have developed aggressive PNETs (cases) and MEN1 patients who have developed non-aggressive PNETs (controls). Aim 4: Validate the potential miRNA biomarkers identified from Aim 1 in MEN1 patients who have developed aggressive PNETs and in MEN1 patients who have developed non-aggressive PNETs, using a targeted qRT-PCR approach (in serums), as well as to see the relationship of potential miRNA biomarkers with patients survival.
As citizens of the information age, humans leave digital traces of behavior in their communication and movement patterns through our cell phone. The Global Positioning System (GPS) technology tracks the way persons commute to school or work or when visiting family and friends. Circadian rhythmicity describes the concept that many of the bodily functions follow a roughly 24-hour rhythm. Usually, the ability to do concentrated and focused work is best during daytime while humans rest and sleep during nighttime. The current study wishes to look for a relationship between patterns in participants' cell phone use (Android only at this point) and several of their bodily functions.
Nutrasorb is a newly developed food product (see www.nutrasorb.com). This study will use the Nutrasorb soy protein product that is matrixed with polyphenols from blueberries and green tea extract, and test for efficacy as a nutritional countermeasure to exercise-induced physiologic stress (i.e., immune dysfunction, inflammation, and oxidative stress) using both traditional and metabolomics-based outcome measures.
This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress, and innate immune function using traditional and metabolomics-based profiling.
The purpose of this study is to collect specimens to perform metabolic profiling of serum and urine from patients with colorectal cancer, colon polyps and healthy patients.
The aim of this study is to better understand how tenapanor affects the metagenomics and metabolomics of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor is the newest FDA-approved agent for IBS-C. It is a small molecule that inhibits the NHE3 receptor, leading to impaired sodium and water absorption in the intestine. Previous clinical trials comparing tenapanor to placebo showed that a 50 mg dose of tenapanor led to increased bowel movements and decreased abdominal pain. This study consists of an 8-week treatment period in which subjects will ingest one capsule of tenapanor (50 mg per dose), twice daily, and send in stool samples following 4 weeks and 8 weeks of treatment.
The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease.
In this study, study investigators will collect embryo culture media on day 5 of vitro fertilization (IVF) culture, prior to vitrification and embryo transfer for testing via Metabolomic screening. Metabolomics is a new, non-invasive method of embryo selection which involves testing discarded embryo culture media for analytes secreted by the developing embryo. These analytes can be used to determine the implantation potential, and ploidy, of the embryo. This study will take place at multiple locations in the United States and Spain.
The purpose of this study is to determine the effects of a single bout of exercise on changes in the genes and small molecules in blood and fat tissue, before and after a bout of exercise. This research may contribute to a better understanding of the beneficial effects of exercise on the body.
The proposed study has two primary objectives i.e. to examine how improvements in diet quality via a personalized dietary intervention 1) benefit cardiometabolic outcomes in young Black adults differentially compared to non-Hispanic White adults, and 2) improve carbohydrate and lipid metabolism in relation to the gut microbiome.
This is primarily a feasibility study to determine whether quantitative measurement of volatile organic compounds (VOCs) in the breath of parturients undergoing labor is possible. Aim A: To determine baseline values of breath metabolites and volatile organic compounds (VOCs) in the breath for term pregnant women. Aim B: To gather preliminary data to determine breath metabolite and volatile organic compound (VOCs) signature change during labor and delivery. Aim C: Compare the breath metabolite and volatile organic compound (VOCs) signature women undergoing induction compared to spontaneous vaginal deliveries.
The study team will evaluate whether metabolomic signatures of neurocognitive decline trajectories are exacerbated by the presence of type 2 diabetes mellitus (T2D) and whether these signatures contribute in part, to ethnic disparities in cognitive decline between European Americans and African Americans with T2D.
The American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.\[1, 2\] Insulin resistance in skeletal muscle is believed to be a critical contributor to the metabolic syndrome which increases the risk for cardiovascular disease (CVD). Conversely, exercise improves insulin sensitivity and many other facets of skeletal muscle function and metabolism; however, it is unclear if this positive effect can be "imprinted" in the skeletal muscle of the fetus with maternal exercise and accordingly diminish CVD risk in offspring. Our previous studies found that exercise during pregnancy leads to improved heart measures and reduced adiposity.\[3-6\] These studies demonstrated the potential for maternal exercise to reduce risk for CVD, but the cellular mechanisms involved, however, are not clearly evident. The proposed project will fill this critical gap and assess the influence of maternal exercise intervention to "imprint" progenitor stem cells in the fetus (umbilical cord tissue) to develop into insulin sensitive skeletal muscle and also improve indices of infant morphometry and movement. Using a randomized design, 160 women will perform either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk. The investigators will test the central hypothesis that exercise during pregnancy alters skeletal muscle in a manner which decreases the risk of heart disease in offspring. To test this central hypothesis, the investigators will pursue two specific aims: Aim 1- Determine the ability of regular maternal exercise to imprint key myocellular metabolic (insulin sensitivity) properties of offspring mesenchymal stem cells (MSC), neuromotor function, and morphometry. Aim 2- Determine the distinct abilities of regular maternal exercise to imprint the metabolome of offspring MSC.
The goal of this study is to understand the impact on the human immune system's response to the four strain flu vaccine in individuals who have "imprinted" on specific influenza strains. It will also consider the effects of repeated prior annual influenza vaccination on the immune system.
The present record represents a secondary data analysis of the Modification of Diet in Renal Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of dietary intake as well as biomarkers of kidney disease progression.
The investigators are seeking to enroll 8 children ages 2-18 already undergoing upper endoscopy. For the purposes of research, a peripheral blood and clean catch urine specimen will be obtained to measure plasma and urine metabolomics. The data will be used to determine if there are any key differences in the metabolite profile of subjects found to have eosinophilic esophagitis (EoE) versus non-EoE subjects. Once these metabolites are identified, the investigators will seek to enroll many more subjects for a validation phase.
Purpose: The purpose of this study will be to examine the feasibility and acceptability of a 6-week high intensity interval training (HIIT) program in patients with knee OA symptoms ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body metabolism induced by 6-weeks of HIIT. Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA Procedures (methods): All participants will be assigned to the single-arm of the study in which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability, feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes will include whole body metabolism markers, inflammation, and a set of physical function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness, isometric knee extensor and flexor strength (factors associated with physical function and symptomatic knee OA progression), and body composition.
The compliance of participants in cranberry related clinical trial is poor due to the bitterness and astringency of cranberry products. There is a pressing need for an effective approach to verify participant compliance. The PLS-DA (Partial Least Squares Discriminant Analysis) /OPLS-DA (Orthogonal Partial Least Squares Discriminant Analysis) models established from the investigator's previous study provide an opportunity to identify cranberry juice consumers. In this blinded, placebo-controlled, cross-over study, investigators hypothesize that the established statistical models of PLS-DA (Partial least squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant analysis) can identify cranberry juice consumers and non-consumers by analyzing the metabolomic changes in blood and urine among young women. In order to further explore the function of cranberry, microbiome profile will also be compared between cranberry juice consumption and placebo consumption after long-term treatment. Another comparison of metabolomic changes between short-term treatment and long-term treatment will be made to further identify candidate biomarkers of cranberry consumption and explore the correlation between acute effects and chronic effects of cranberry.
The purpose of this study is to identify metabolic signatures associated with malodor conditions. The investigators will perform state-of-the art metabolomics tests and bioinformatic data mining to explore if conditions leading to malodor can be screened by metabolomic profiling of urine samples.
With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate nutrition-related factors, such as diet and body composition, on outcomes in patients with CF. The data generated from this study will be used to inform future nutrition intervention studies in adults with CF and CFRD.
One promising but understudied area in the field of testosterone (T) therapy is its effect on metabolism and the development of type II diabetes. Metabolomics is a powerful research tool that can detect very early signs of metabolic derangement that may lead to metabolic disease. In this observational study, investigators aim to apply metabolomics in order to better understand how T therapy influences metabolism. In a clinical population of outpatient men with T deficiency investigators will perform comprehensive clinical evaluations and also obtain blood for metabolomics. This will be done once prior to T therapy and again after 4-6 months of T therapy. Investigators hypothesize that they can detect metabolic derangements in men with T deficiency and that these derangements will improve with T therapy.
Individuals with insomnia have been shown to have higher overall metabolic rates compared to good sleepers, but it is not known which metabolic processes are involved. The goal of this study is to compare a wide array of metabolic processes in 15 people with insomnia and 15 good sleepers. We hypothesize that there will be distinct metabolic processes that are functioning differently in those with insomnia.
The PI will study metabolism during liver regeneration in living liver donors
Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling intensely for 75 kilometers will support substrate utilization during exercise (as determined through metabolomics) and improve performance compared to water only, and attenuate inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.
Anaphylaxis is defined as a serious allergic reaction mediated by IgE that is often difficult to diagnose due to the wide heterogeneity of clinical manifestations. The inciting agent is often difficult to pinpoint and may include food, environmental allergens in patients undergoing allergen immunotherapy, insect stings, and medications. Evidence of allergy by demonstration of a positive skin test to the inciting agent, is helpful only if skin testing is available. The only diagnostic modality that is useful in the diagnosis of anaphylaxis when IgE skin testing is not available and the inciting agent is unknown, is an elevated serum tryptase level. However, a diagnosis of anaphylaxis can be made without a tryptase level or if the tryptase level is normal. A simple, non-invasive test for patients with anaphylaxis is not currently available and would be helpful to diagnose and to guide further management options. Patients who develop anaphylaxis to environmental allergens or venoms during routine outpatient subcutaneous allergen or venom immunotherapy are an ideal population to study as we are able to evaluate these specific reactions in a controlled, clinical environment. Although anaphylaxis is uncommon, the incidence has been estimated to vary between 0.01 and 4 percent of all allergy injections. Subcutaneous allergen or venom immunotherapies are a well established form of therapy for patients with allergic rhinitis, allergic asthma, or a confirmed sensitivity to stinging insects. Serial blood sampling can be performed in this group of patients during a reaction and at baseline one week after a reaction, thereby allowing each patient to serve as his or her own biological control. Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, drug therapy, or allergen or venom immunotherapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined. The investigator plans to use metabolic profiling of blood samples collected at the time of anaphylaxis and one week after, to see if a simple, non-invasive test for patients with anaphylaxis could be developed.
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined. Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.