Clinical trials

Healthy foods, including peanuts, may improve brain function, which is essential for cognitive and metabolic health, and may contribute to improved food intake regulation. It is therefore important to investigate the specific effects of peanut butter on cerebral blood flow responses, as well as the potential associated functional benefits. The researchers hypothesize that long-term peanut butter consumption improves vascular function in the brain, thereby enhancing cognitive performance and appetite control in middle aged and older adults. Objective: The primary objectives are to investigate in middle aged and older men and women the effect of 16-week peanut butter consumption on brain vascular function, while we will also assess changes in cognitive performance and appetite-related brain reward activity (secondary objectives). Cerebral blood flow responses (brain vascular function) will be non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).Study design: This intervention study will have a randomized, controlled, cross-over design. The total study duration will be 40 weeks, including two 16-week interventions, separated by a washout period of at least 8 weeks. Study population: Forty-five middle-aged and older men and women (aged 45-75 years) without a history of cardiovascular diseases or complaints will participate. This population is expected to have a decreased cerebral blood flow at baseline and are also at increased risk of cognitive impairment, allowing for improvement by the intervention. Intervention: Study participants will receive, in random order, 45 g of peanut butter daily (peanut intervention) or no peanut butter (control) for a total of 16 weeks, separated by a wash-out period of at least 8 weeks. Main study parameters/endpoints: At baseline, first anthropometric measurements will be performed and blood pressure will be determined. In addition, a fasting blood sample will be drawn. Another fasting blood sample will be drawn at eight weeks, while participants have to attend the research facilities to perform follow-up measurements after sixteen weeks. The primary endpoint is the difference at follow-up in the cerebral blood flow response between peanut butter intervention and control periods. Cognitive performance will be assessed, while the researchers will also focus on appetite-related brain reward activity (secondary outcomes).

The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS? Participants will read words and sentences while they are in a solo setting and interactive setting.

The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.

The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

The goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. The main questions it aims to answer are: 1. How does consuming the fermented foods impact the gut microbiome? 2. Does this interaction between the fermented foods and the gut microbiome affect inflammation? Participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses. Researchers will compare the gut microbiome and inflammation between these two diets.

The goal of the study is to examine alcohol use behaviors of young adults through the use of testing the feasibility of adding an innovative brief personalized alcohol biomarker feedback component (TAC feedback) to an existing efficacious personalized feedback intervention, eCHECKUP TO GO (eCTG), and how (if at all) the intervention impacts drinking behaviors in high-risk college students. The study will conduct a feasibility assessment of the TAC feedback component, and will also assess the effects of the eCTG + TAC at 6-months post-baseline relative to an eCTG only group.

The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner. Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess: 1. Within- and between-day variability of testing 2. Within- and between-technician variability of testing 3. Variability due to positioning and post-scan processing 4. Variability due to different DXA scanning equipment Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults. Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications. Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.

The purpose of this study is to examine how participating in exercise together versus separately influences brain function, cognitive performance, mood, and parent-child connection in mother-child dyads. Mothers and their children will complete two fitness class visits at a participating community fitness facility/CrossFit affiliate. During one visit, mothers and children will exercise in separate age-appropriate classes, and during the other visit they will exercise together in a shared class. Before and after each exercise session, participants will complete brief assessments of cognition, mood, and brain activity using a portable electroencephalography (EEG) device. Findings from this pilot study will help determine the feasibility of conducting community-based neuroscience research and may inform future family-centered physical activity programs designed to support brain, emotional, and social health.

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

The overall goal of this research is to provide pilot data that informs and drives a larger scale research project, incorporating multiple contemporary measurement modalities, to understand the utility and pathological mechanisms by which exposure to nature-based settings may aid in recovery time and symptom relief of individuals suffering from concussion, and decrease their risk of developing Persistent Post-Concussion Syndrome (PPCS). We hypothesize that successful adherence to a nature-based exposure therapy intervention program will decrease recovery time and severity of symptom trajectory of concussion, as measured through multimodal assessments of brain structural and functional integrity.

The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

The purpose of this study is to find out if full-fat dairy and low-fat dairy have similar effects on risk factors for heart disease and diabetes. During the study, participants will consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese). Each type of dairy will be consumed for 6 weeks with a ≥4-week break between. Measures will be taken to evaluate blood cholesterol, blood sugar, body weight, inflammation, blood pressure, heart health and dietary intake at the beginning and end of each 6 week period.

The proposed study will examine whether eating yogurt every day can improve brain and gut health in children. Prior research suggests that yogurt may support cognitive functions like self-control, but more studies are needed to confirm this. The study will follow 60 children from Central Pennsylvania, ages 8 to 10, who will be randomly assigned to drink either fruit juice (control group) or yogurt smoothies once or twice a day for four weeks. Researchers will compare how different amounts of yogurt affect children's thinking skills (like memory and focus), brain activity, and gut bacteria. These changes will be measured through brain scans, computer-based thinking tasks, surveys, and stool samples. The study will also collect information about children's overall diet. The goal is to find out if yogurt can support healthy brain and gut development and to determine the right amount to include in a child's daily diet. Results will help guide future research on how nutrition supports children's health.

Strong empirical evidence shows food marketing promotes excess energy intake and obesity. Yet, not all children are susceptible to its effects and this variability is poorly understood. Identifying sources of this variability is a public health priority not only because it may elucidate characteristics of children who are most susceptible, but also because it may highlight novel sources of resiliency to overconsumption. The proposed research will use state-of-the art, data-driven approaches to identify neural, cognitive and behavioral phenotypes associated with resiliency to food-cue (i.e. food advertisement) induced overeating and determine whether these phenotypes protect children from weight gain during the critical pre-adolescent period.

The goal of this clinical trial is to learn if intervention with Landing Place mental health app can support wellness in college students. The main questions it aims to answer are: Can the app increased well-being in college students? Will the app have increased use and usability by the college students? Researchers will compare two groups of participants to see if the app intervention will increase wellbeing and app usability rates. Participants will randomly assigned into group 1 and 2. Group 1 will not use the app at all. Group 2 will use the app almost every day for 4 weeks.

Most attempts to quit smoking end in relapse, or a return to regular smoking. One of the biggest threats to cessation is a lapse (i.e., any cigarette use during a quit attempt). Thus, characterizing why lapses occur is essential to understanding and preventing smoking relapse. Functional magnetic resonance imaging (fMRI) is a promising method for characterizing the psychological processes that lead to smoking lapses because it provides a way to measures patterns of brain activity thought to reflect relevant mental processes as they change over time. However, methodological issues have hindered the ability to capitalize on this potential and prevented an understanding of how brain activity and corresponding psychological processes unfold in the critical moments that immediately precede a smoking lapse. The proposed project will address this knowledge gap using a novel fMRI paradigm adapted from a well-validated behavioral lapse task. The goals of the project are to characterize changes in brain activity that lead up to a lapse and to investigate how these changes are related to concurrent affect and subsequent cigarette use.

The purpose of this randomized control trial is to compare how food cravings, food selection, and food consumption change in response to frequent food advertisements compared to non-food advertisements in adults taking GLP-1 (weight loss) medications. The primary question we aim to answer is: do GLP-1 medications reduce an individual's vulnerability to external triggers that drive food cravings and consumption? Participants will: * report daily food consumption for a total of 10 days, * receive eight daily prompts to view food or non-food related advertisements, and respond to a short 9-question survey for 7 days, * answer several questionnaires, * and complete two in-person visits to complete a virtual reality food selection task.

The goal of this clinical trial is to test whether an adaptation of an evidence-based, couple-based preventive intervention at the transition to parenthood improves reduces obesity risk among infants and parents in military families via improved interparental support and coordination around health lifestyle behaviors and parenting. The main question it aims to answer is whether an adapted, innovative family-focused approach to obesity prevention can reduce rapid infant weight gain, new mothers' postpartum weight retention, and fathers' weight status. Participants randomized to the Healthy Family Foundations (HFF) intervention condition will participate in 10 online group classes (5 prenatal and 5 postnatal). Participants randomized to the control condition will receive standard of care and opportunities for education at their site. Researchers will compare the Healthy Family Foundations (HFF) intervention group with a Standard of Care control group to see if there are differences in weight, coparenting support, parent mental health and parent health behaviors.

The purpose of this study is to evaluate the effectiveness of the Thrive Initiative's parent-education program delivery methods by comparing hybrid (i.e., a combination of online and group components) program delivery to online-only program delivery. The Thrive Initiative consists of four, universal parent-education programs that correpsond to specific child developmental periods. These programs inlcude: Take Root for parents/caregivers of 0-3-year-old children; Sprout for parents/caregivers of 3-5-year-old children; Grow for parents/caregivres of 5-10-year-old children; and Branch Out for parents/caregivers of 10-18-year-old children. The effectiveness of delivery method will be examined for each program. Eligible participants for this study will be United States Air Force service members or dependents who are caregivers of a child 0-18 years old. The study will involve randomization to condition meaning that participants will be assigned to the online-only or hybrid program delivery condition by chance.

This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of Lion Hearts, a community-based, family-centered physical activity intervention designed to improve cardiovascular health among mother-child dyads. Developed through community co-design, the 12-week intervention is delivered in local CrossFit affiliates and includes twice-weekly fitness sessions incorporating functional movement, goal setting, teamwork, and health education. The study aims to assess changes in physical activity, fitness, and cardiovascular health markers, as well as family dynamics and motivation for physical activity. Participants complete baseline, mid-, post-, and 3-month follow-up assessments, including surveys, fitness testing, accelerometry, and optional lab work. Findings will inform the refinement of the intervention for future large-scale trials.

The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time? Participants will read words and sentences while they are interacting with their caregivers.

This study looks at whether using secure digital systems to share information between pediatric health care providers (during regular well-child visits) and social care providers (during regular visits with WIC nutritionists) can help mothers receive consistent guidance on responsive parenting to support healthy child growth and development. Responsive parenting means learning how to respond to a baby's needs in ways that support healthy eating, sleep, activity, and emotion regulation habits. The main questions this study aims to answer are: 1. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting to support healthy growth from birth to 24 months? 2. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting, improve responsive parenting practices and child diet quality? The investigators will compare the group that receives secure digital systems for sharing information on responsive parenting to a group that receives standard care (does not receive this) to see if secure digital systems for sharing information on responsive parenting work to support healthy child growth and development. The goal is to see if this approach can improve early health behaviors and reduce health disparities for families in rural, low-income communities.

Increased availability of high-energy dense foods has contributed to a pediatric obesity epidemic, with 23% of United States children currently presenting with the disease. How children eat contributes to both overconsumption and greater adiposity. However, it is unclear if laboratory measures of children's eating style generalize to the home environment, where children consume two thirds of their total energy. The study will 1) test if child eating styles observed in the lab generalize to more ecologically valid home environments and 2) identify aspects of home food environment that amplify obesogenic eating behaviors. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children to constrain variability in energy requirements. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory (counter-balanced order) in addition to a 'typical' meal at home. To study how adiposity relates to "obesogenic" styles of eating, gold standard dual x-ray absorptiometry will be used.

The goal of this clinical trial is to learn if an 8-week, community-based pickleball program can improve sensory-motor function and reduce the severity of core autism symptoms in adults ages 18-45 with autism spectrum disorder (ASD) who can participate independently without a caregiver. The main questions it aims to answer are: 1. Does participating in the pickleball program improve sensory-motor function (including visual-motor integration and proprioceptive bias), measured using the HaptiKart task and a pickleball skill assessment? 2. Does participating in the pickleball program reduce core autism symptom severity, measured by the Social Responsiveness Scale, 2nd edition (SRS-2)? Researchers will compare an early-start pickleball group to a delayed-start control group (who continues usual activities at first) to see if the pickleball program leads to greater improvements in sensory-motor outcomes and ASD symptom severity. Participants will: * Complete an in-person baseline visit at a local public library to provide written consent, complete surveys (SRS-2, PROMIS Depression and Sleep measures, and WHOQOL-BREF), and complete a video game-based sensory-motor assessment (HaptiKart). * Be randomly assigned to either start pickleball classes immediately or after an initial delay period. * Attend pickleball classes twice per week for 8 weeks (90 minutes per class; 16 sessions total), led by trained instructors at community indoor court facilities. * Continue their usual activities during periods when they are not assigned to pickleball classes. * Complete a brief pickleball skill assessment during the intervention period at their first and last class. * Complete follow-up assessments after each phase of the study to repeat surveys and sensory-motor testing. * Participants will also wear a small activity monitor (ActiGraph) during pickleball sessions to measure in-class physical activity levels, and complete brief online check-ins about safety/injury and program feedback during the intervention period.