Clinical trials

Adults with type 1 diabetes have elevated cardiovascular disease risk, and systolic blood pressure is a leading modifiable contributor to that risk. Aerobic exercise lowers blood pressure but poses time and glycemic-management barriers for people with type 1 diabetes. Inspiratory muscle strength training is a brief, home-based, device-based intervention that takes about five minutes per day and has lowered systolic blood pressure in other adult populations. This pilot trial will test whether eight weeks of daily high-resistance inspiratory muscle strength training lowers blood pressure and improves vascular function in adults with type 1 diabetes. Participants will be randomized 2:1 to high-resistance or very-low-resistance sham training using a POWERbreathe K3 device and will complete 30 training breaths per day at home for eight weeks. Outcomes are assessed before and after the training period.

Millions of adults in America have too much body fat, resulting in obesity. Obesity is detrimental to health and causes disease. Obesity reduces brain health, which causes the brain to function less effectively. Additionally, a lack of exercise contributes to poorer brain health. Most individuals feel they do not have time to exercise. There is a need for a quicker type of training that improves brain health. Newly developed breathing exercises could be a time-efficient, cost-effective, and home-based practice to increase brain health. This practice acts as weightlifting for breathing muscles. These new breathing exercises have already been shown to increase heart health. Heart health is linked to brain health; if an intervention helps the heart, it is likely to also help the brain. It is currently unknown if breathing training can improve brain health in younger adults with obesity. The investigators will utilize the same 8-week program shown to improve heart health. Testing will be conducted before and after the breathing training. The first part of the study will determine if breathing exercises help brain health. Obesity also causes inflammation. This is measured via blood but affects the entire body. It is thought to cause some of the negative outcomes of obesity. By lowering inflammation, it is likely to improve overall health. Breathing exercises may reduce inflammation, but more research is required. The second part of this study will determine whether breathing exercises help reduce inflammation. This study will determine if brain health can be improved in adults with obesity. This could help 40% of American adults with obesity to live longer and healthier lives.

This study aims to investigate the effect of isometric handgrip training on brain blood vessel function in physically inactive adults. Isometric handgrip training is a promising strategy for lowering blood pressure and improving vascular health, but no previous investigations have studied the effect of training on markers of brain blood vessel function. Based on previous work showing improvements in vascular function after isometric handgrip training, we hypothesize that isometric handgrip training will improve key markers of cerebrovascular function.

The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.

Episodic memory allows us to project ourselves back in time to mentally re-experience the past in vivid detail. This remarkable feat helps to define our personal identities and enables context-appropriate predictions that guide adaptive behavior. Unfortunately, episodic memory loss is a common cognitive consequence of neurological disease, psychiatric disorders, and normative aging, that reflects dysfunction in the hippocampus and the neocortical network to which it connects. This decline can present along a range of severity that spans an impoverished ability to recollect fine-grained event details, e.g., the color of the shirt your spouse was wearing at a birthday party, to forgetting course-grained event details, e.g., having attended a birthday party last weekend. Treating these kinds of memory loss remains challenging because interventions must target information that is definitionally idiosyncratic. However, recent methodological and theoretical advances in cognitive neuroscience reveal novel strategies that may solve this problem. Evidence from behavioral, neuroimaging, and computational modeling studies suggest that the degree to which episodic memories overlap in the hippocampus can be modified in a predictable, experience-dependent manner. Specifically, strong concurrent reactivation of multiple memories can enhance recall of coarse-grained episodic information by increasing hippocampal integration. Conversely, coupling strong and moderate reactivation of memories can enhance recall of fine-grained episodic information be increasing hippocampal differentiation. Consistent with this idea, recent evidence suggests that using a smartphone to record and subsequently replay real-world memory cues can indeed improve episodic memory by reducing representational overlap among memories in the hippocampus. Against this background, this proposal is organized around two primary aims. First, we seek to establish smartphone-guided memory reactivation protocols that selectively promote integration and differentiation of real-world episodic memories in the hippocampus. Experiments in this aim will specifically ask whether unstructured and structured (in terms of narrative, space, and time) reactivation can be used to achieve these outcomes. Second, we will ask whether the benefits of memory reactivation are associated with behavioral and representational costs. Experiments in this aim will probe for undesirable downsides that accompany, or potentially explain, reactivation-based improvements in episodic memory. Our approach combines smartphone technology, pattern-based analysis of functional neuroimaging data, and careful characterization of recall data with neurocognitive theory inspired by computational models of learning mechanisms. Achieving our aims will establish an empirical foundation on which future interventions can be built to systematically target real-world episodic memories at a level of abstraction, i.e., fine-grained vs. coarse-grained detail, that is appropriate for the severity of memory loss.

Episodic memory allows us to project ourselves back in time to mentally re-experience the past in vivid detail. This remarkable feat helps to define our personal identities and enables context-appropriate predictions that guide adaptive behavior. Unfortunately, episodic memory loss is a common cognitive consequence of neurological disease, psychiatric disorders, and normative aging, that reflects dysfunction in the hippocampus and the neocortical network to which it connects. This decline can present along a range of severity that spans an impoverished ability to recollect fine-grained event details, e.g., the color of the shirt your spouse was wearing at a birthday party, to forgetting course-grained event details, e.g., having attended a birthday party last weekend. Treating these kinds of memory loss remains challenging because interventions must target information that is definitionally idiosyncratic. However, recent methodological and theoretical advances in cognitive neuroscience reveal novel strategies that may solve this problem. Evidence from behavioral, neuroimaging, and computational modeling studies suggest that the degree to which episodic memories overlap in the hippocampus can be modified in a predictable, experience-dependent manner. Specifically, strong concurrent reactivation of multiple memories can enhance recall of coarse-grained episodic information by increasing hippocampal integration. Conversely, coupling strong and moderate reactivation of memories can enhance recall of fine-grained episodic information be increasing hippocampal differentiation. Consistent with this idea, recent evidence suggests that using a smartphone to record and subsequently replay real-world memory cues can indeed improve episodic memory by reducing representational overlap among memories in the hippocampus. Against this background, this proposal is organized around two primary aims. First, we seek to establish smartphone-guided memory reactivation protocols that selectively promote integration and differentiation of real-world episodic memories in the hippocampus. Experiments in this aim will specifically ask whether unstructured and structured (in terms of narrative, space, and time) reactivation can be used to achieve these outcomes. Second, we will ask whether the benefits of memory reactivation are associated with behavioral and representational costs. Experiments in this aim will probe for undesirable downsides that accompany, or potentially explain, reactivation-based improvements in episodic memory. Our approach combines smartphone technology, pattern-based analysis of functional neuroimaging data, and careful characterization of recall data with neurocognitive theory inspired by computational models of learning mechanisms. Achieving our aims will establish an empirical foundation on which future interventions can be built to systematically target real-world episodic memories at a level of abstraction, i.e., fine-grained vs. coarse-grained detail, that is appropriate for the severity of memory loss.

Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.

The purpose of this research study is to improve pain management for individuals with chronic knee osteoarthritis pain. Specifically, we are comparing the effects of a mindfulness meditation practice with those of oral diclofenac, a common NSAID medication prescribed for knee osteoarthritis pain.

The goal of this clinical trial is to evaluate the postprandial and long-term effects of dietary stearic acid on vascular function in overweight or obese adult males and females aged 40-70 years. The main questions it aims to answer are: 1. Does consuming a high stearic acid-rich meal improve postprandial vascular function compared to a high oleic acid-rich meal? 2. Does a 14-day stearic acid-rich diet improve fasting vascular function compared to an oleic acid-rich diet? 3. Does a 14-day stearic acid-rich diet reduce the impairment of postprandial vascular function following a high palmitic-acid challenge meal? Participants will: * Complete screening questionnaires, a 3-day food log, body composition measurements, and fasting blood and urine tests. * Consume a provided, 14-day controlled diet high in palmitic acid while avoiding outside food and beverages other than water. * Be randomly assigned to consume a provided 14-day diet high in either stearic acid (cocoa butter blend) or oleic acid (plant oil blend). * Attend two 5-hour testing visits at the clinic after overnight fasting. * Undergo intravenous (IV) catheter placement for repeated blood sampling and non-invasive vascular health assessments (ultrasound artery checks and pulse measurements). * Consume assigned high-fat test meals within 15 minutes and undergo hourly vascular and blood assessments over a 4-hour period.

This 8-week parallel-arm randomized controlled trial (N=70; ages 6-13) will determine the impact of daily almond butter consumption on gut microbiome composition and function, intestinal barrier integrity, and cardiometabolic health in school-aged children. Participants will be randomized to either a once-daily snack of personalized-portion almond butter (ALB; 16g, Creamy Natural Almond Butter) or an isocaloric nut-free chocolate spread control (CTL; 16g, Cadbury Milk Chocolate), each served on two plain unsalted saltine crackers, added to their habitual diet. The primary outcomes include oro-gut microbial composition and diversity, gut microbial functional capacity and metabolomics (SCFAs, bile acids, amino acid metabolites), and intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, systemic inflammation, appetite-regulatory and metabolic hormones, and sleep-related biomarkers. Feasibility, adherence (weekly logs; serum α-tocopherol), and precision nutrition potential will also be assessed, with stratified analyses by age, sex, BMI, ethnicity, and pubertal stage. This pilot trial will generate the first multi-omics characterization of almond butter's effects on the gut-immune-metabolic axis in children.

This parallel-arm, randomized controlled trial will evaluate the effectiveness of a 6-week pulse-focused nutrition intervention in school-aged children (6-13 years). The study aims to assess adherence to a pulse-based diet providing 1.5 cups of pulses per week and to examine the effects of whole-cooked pulse consumption on gut health, including gut microbiome composition, metabolomic profiles, and gut barrier function. Secondary objectives include evaluating the impact of pulse consumption on markers of metabolic health and inflammation. Forty participants will be randomized to either a pulse-focused nutrition education program with weekly provision of pre-measured pulses (black beans, lentils, and chickpeas) or a pulse-focused nutrition education program in which participants independently procure their own pulses. Participants will follow the assigned intervention for 6 weeks.

This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.

The goal of this study is to determine whether consuming a commercially available exogenous ketone supplement (KetoneIQ®) affects cognition, specifically marksmanship, under physical stress (i.e., exhaustive exercise). The main questions we seek to answer are: * Does the supplement save cognitive performance under stress compared to a placebo? * Does the supplement improve marksmanship under stress compared to a placebo?

Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.

Working memory (WM) is the ability to hold relevant information in mind in the absence of sensory input. The capacity for WM is a foundation for cognitive control and higher cognitive function more broadly. Previous research demonstrated that during the delay period of WM tasks, oscillatory electrical activity in the prefrontal cortex in the theta-frequency band (4-8 Hz) increased in amplitude. However, other groups found that the slope of the aperiodic signal in the brain was positively correlated with individual differences in WM capacity. Since low-frequency power and a steeper slope of the aperiodic signal are confounded in many analyses, it is not clear whether the slope of the aperiodic signal or the amplitude of low-frequency oscillations underlie WM capacity. With many studies investigating the causal role of theta oscillations in WM, the purpose of this project is to investigate the role of the aperiodic signal in WM performance.

This study is a randomized controlled pilot examining the implementation of an adapted intervention, Skills Training in Affective and Interpersonal Regulation-Narrative Therapy (STAIR-NT), among a first responder population with a history of TBI and PTSD.

Initial non-randomized trial of behavioral parent training (BPT) compared to central executive training (CET), followed by a randomized controlled trial of CET+BPT for young children with ADHD.

Medical marijuana use among adults 50 and older has more than doubled in the past decade with exponential increases projected in this demographic by 2050, and prescription opioids are one of the most common treatments for pain management in this population. To date, no studies systematically assess driving performance in a rigorous and ecologically valid manner accounting for long-term medical marijuana use and/or the combined effect of prescription opioid use in adults 50 and older who endorse chronic or severe non-malignant pain. Further, studies examining how older adults self-regulate prescription medication use and driving behavior is limited, with none rigorously examining medical marijuana.

The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will induce self-dehumanization using a novel experimental self-dehumanized future condition (i.e., a futuristic paradigm that likens the individual to a machine) and compare this group to a control group to analyze the pathway between higher perceptions of self-dehumanization, suicidal ideation, and changes in oxytocin concentrations. It is hypothesized that participants randomly assigned to the self-dehumanized mechanistic future condition will exhibit temporary increases in suicidal ideation (which will be thoroughly assessed, intervened upon following the induction) and decreases in oxytocin concentrations as compared to the control condition, which will not display significant changes. Further, we will explore if the magnitude of the oxytocin response will partially mediate the change in suicidal ideation.

This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.

The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application. 1. Does receiving text messages increase engagement in a mindfulness app? 2. Does an integrated gaming app increase engagement in a mindfulness app? Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will: 1. Use a mindfulness and gaming mobile health application for 28-days. 2. Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.

The purpose of this study is to evaluate the Young Adult Centered HealthForce Training (YACHT) package in 41 Florida Department of Health (FDOH) contracted Counseling, Testing, and Referral (CTR) agencies across six Florida End the Epidemic (EHE) counties. Agencies will be cluster-stratified and randomized to either the YACHT intervention (20 agencies) or a comparison group (21 agencies). The primary effectiveness outcome is the number of HIV tests administered to young men who have sex with men (YMSM), and the primary implementation outcome is providers' fidelity to evidence-based practices (EBPs), including risk reduction counseling and PrEP referrals, as measured through mystery shopper assessments and agency-level data obtained from the Florida Department of Health. The study also includes qualitative interviews with agency representatives to identify barriers and facilitators to successful implementation of youth-specific EBPs within HIV CTR settings.

The goal of this clinical trial is to determine if a high potassium intake can counteract the harmful effects of excess sodium on endothelial function in older adults with no history of cardiometabolic disease. The main questions it aims to answer are: 1. Can a high potassium intake attenuate dietary sodium-induced endothelial dysfunction in older adults. 2. Do changes in endothelial function in response to alterations in sodium and potassium intake differ by sex. Participants will participants will consume three controlled diets for 10 days each with a minimum 14-day washout between interventions. The order in which participants consume the diets will be randomized. The study diets will vary in sodium and potassium content. Measures of cardiovascular health (blood pressure, arterial stiffness, endothelial function) will be assessed at the end of each diet.

The present study seeks to develop, refine, and test a novel psychological treatment for boosting mental health resilience among college students. This Fundamental Adaptive Skills Training (FAST) will be evaluated in a randomized controlled trial. We will seek to recruit 5 undergraduate students as participants for a pilot phase and 100 undergraduate students for a randomized controlled trial. The primary questions we are seeking to answer in this trial are: Do participants rate the FAST intervention as acceptable? Does FAST improve sleep quality, physical activity, anxiety sensitivity, loneliness, and social isolation for college students? Participants will: Receive the active FAST or a placebo control Relaxation and Mindfulness Training (RMT) and will complete measures at baseline, week 2, and week 4.

The Spanish language Healthy Choices intervention pilot study (N=45) holds direct relevance to the United States and federal priorities related to improving HIV outcomes to reduce transmission using implementation science models. If Healthy Choices is found to have a clinical signal of impact, our team is committed to testing the intervention in the United States and training Spanish speaking HIV care navigators on the intervention, specifically in the southern United States where Spanish speaking populations are concentrated, namely in Alabama, Texas, New Mexico, Arizona, Nevada, and Florida.