Clinical Research Directory

Non-Invasive Assessment of Early Health Determinants in Children and Adolescents

LONGEVITY-NEXT is a single-center, non-profit observational study designed to assess early non-invasive determinants of cardiometabolic, functional, behavioral, and environmental health in children and adolescents aged 6 to 17 years from the general population. Participants will undergo a standardized 15-20-minute non-invasive assessment including anthropometric measurements, blood pressure and heart rate, handgrip strength, dietary habits and adherence to the Mediterranean diet, physical activity, recreational screen time, sleep duration, tobacco smoke exposure, early-life factors, chronic health conditions, and family cardiometabolic history. The primary outcome is the distribution of the number of unfavorable cardiometabolic, behavioral, and environmental health domains per participant. The study involves no experimental treatment, drug, investigational medical device, invasive procedure, or modification of usual care. Optional repeated assessments may occur opportunistically during the study while participants remain between 6 and 17 years of age.

Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s

The purpose of this research is to compare weight loss among 3 groups: 1. people who stay on a GLP-1 drug at full strength (Group 1) 2. people who have their dose tapered to every other week, meaning slowly decreasing the dose and frequency of the full prescription you are currently taking (Group 2) 3. people who go off their GLP-1 and instead take an alternative weight loss drug or combination of drugs called phentermine \& topiramate. These are not GLP-1 medications. (Group 3) The investigators want to see if the second and third options are effective at weight loss maintenance. This study will include a total of 60 participants. Participants will be randomly assigned to one of the three study groups. The goals of this current study are to: 1. determine the acceptability of these proposed treatment strategies, 2. collect data about how people's weight changes early on and throughout the study and how well people tolerate the medications. 3. determine whether it is feasible to recruit for a larger, follow-up study. There are 3 on-site visits: at the start, and then 6 and 12 months. The study team will do monthly phone calls in between those visits. At the on-site visits the study team will do various physical measures and collect blood for lab testing and provide participants with counseling to help with weight loss. The study team will instruct participants in a home-based resistance exercise regimen to help maintain muscle mass. This will include exercises such as: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, and bicep curls two to three times a week. If these exercises are deemed too easy, participants may choose to do regular pushups, planks, lunges and/or add a resistance band.

Almonds, Gut Microbiome and Kids

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.

Pulse Education and 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 Study Will Evaluate Cardiorespiratory and Muscular Fitness to Examine Associations With Anthropometric Characteristics and Other Indicators of Cardiometabolic Risk Among Patients With or Without Autism Spectrum Disorder

The goal of this observational study is to evaluate cardiorespiratory and muscular fitness in children with obesity, with and without autism spectrum disorder (ASD), and examine how fitness relates to body measurements, body composition, and cardiometabolic health. The main questions it aims to answer are: * Do children with and without ASD differ in cardiorespiratory fitness and handgrip strength? * Are fitness levels related to body composition and measures of cardiometabolic health? Researchers will compare children with ASD to children without ASD to see if there are differences in fitness, body composition, and cardiometabolic health. Participants will have information from their medical records reviewed, including: * Cardiorespiratory fitness and handgrip strength test results * Height, weight, BMI, and body composition measurements * Blood test results, including HbA1c and cholesterol levels * Age, sex, and other demographic information

Going Places: A Multi-level Intervention to Improve Youth Transportation Efficacy and Physical Activity

Going Places is a community driven intervention to increase transportation self-efficacy among low-income youth, enabling access to community-based programs that promote physical activity and improve long term cardiometabolic health. Going Places was co-developed under the joint leadership of Duke and Durham Parks and Recreation (DPR). Going Places is pilot tested and fully functional. The intervention incorporates a multi-level approach that includes 1) workshops on navigating local transportation systems; 2) field trips and participatory assets mapping activities; and 3) youth transportation advocacy.

Effect of Watermelon on Cardiometabolic Health

The purpose of this study is to determine whether consumption of 355 ml of watermelon juice will: 1. improve cardiovascular and overall metabolic health markers like blood pressure, heart rate, stiffness/flexibility of arteries (blood vessels), blood sugar, cholesterol), and gut hormones 2. contribute to the body's ability to protect itself from the potential cell damage caused by harmful chemical compounds (produced when skin is exposed to ultraviolet (UV) B light, for example). This will be evaluated by measuring how resistant skin is to the damage from UVB light exposure, as well as several markers of bodily stress blood and urine. This will be determined immediately after consuming the juice (to evaluate the effects the juice has on health right away), as well as after 4 weeks of daily juice consumption (to evaluate the effects the juice has on health when consumed consistently over time).

Tirzepatide Impact Assessment Study

This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months. At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study. The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas. Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications. Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.

Behavioral Economic Attributes of Recreation

Risk for developing and dying from heart disease, type 2 diabetes, stroke, and other cardiometabolic conditions is strongly influenced by behavioral risk factors, including poor diet, physical inactivity, and tobacco and alcohol abuse. Behavioral economic models predict engagement in these behaviors as a function of their subjective value, ability to provide immediate gratification, and availability of competing alternatives. A key implication of the behavioral economic model is that increasing the accessibility of compelling alternative sources of reinforcement may displace engagement in unhealthy behaviors. Developing interventions that leverage these insights requires both a clear understanding of the characteristics of the "reward landscape" of U.S. adults, and the impact of altering the reward landscape on behavioral economic processes and health behavior. This pilot study uses a trial within a cohort (TwiC) design to pursue these objectives. A representative sample of adults (N=120) will be enrolled into an observational cohort. Cardiometabolic health will be assessed and quantified based on the Life's Essential 8 (LE8) scoring system,4 which includes 4 behavioral (physical activity, diet quality, sleep, tobacco use) and 4 biomedical (non-HDL cholesterol, glucose, weight status, and blood pressure) factors. Structured home audit tools and an ecological momentary assessment (EMA) protocol will be used to measure environmental access to, demand for, and engagement in various rewarding activities, including different categories of recreational activity, electronic entertainment, social activities, and consumable rewards including food, tobacco products, and alcohol. The inter-relationships between different types of rewarding behaviors as substitutes or complements, and their links with cardiometabolic health, will be examined overall and with stratification by socioeconomic status. Following completion of the first assessment, a subset of participants will be selected for randomization to a recreation-focused intervention or continued observation within the cohort based on their baseline status and protocol adherence. In TwiC designs, the "control" group simply continues to complete observational assessments within the cohort and is not notified that an intervention is ongoing. The BEAR "intervention" group will be approached for consent to participate in a 6-month behavioral economic intervention in which recreational activities are promoted as a strategy to displace cardiometabolic risk behaviors. The scientific aims of the randomized trial component of the study include examining change in LE8 scores, demand for various rewarding activities, discounting rates, and health behaviors. BEAR will also address several feasibility aims, including demonstrating the ability to measure and categorize access to rewarding activities, document recreation-related expenditures by participants, and estimate intervention uptake and acceptability.

Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

This study aims to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers and cardiometabolic parameters in community-dwelling adults

Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment

The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera. The main questions this study aims to answer are: 1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels? 2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels? 3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression? Participants will take part in several simple and mostly non-invasive procedures: 1. Answer questionnaires about their mental health and daily habits 2. Have basic health checks, such as blood pressure, heart rate, and body measurements 3. Provide a blood sample for laboratory testing 4. Complete a facial scan using a camera for about 1 to 3 minutes Researchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works. This study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.

Mango Intake and Gut and Cardiometabolic Health in Hispanic/Latino Adolescents

Mangos contain a number of nutrients that may improve gut and metabolic health. The purpose of this research is to see how eating mangos every day for 4 weeks instead of snacks high in calories and low in nutrients such as cookies, crackers, chips, and candy can impact adolescent health.

Diet and Cardiometabolism in Rosario

The DiCaMeR study is an observational, cross-sectional study aimed at evaluating the relationship between dietary patterns and cardiometabolic health in adults. The study includes adults following vegan, vegetarian, and omnivorous diets residing in Rosario, Argentina. Participants undergo comprehensive assessments including dietary intake, anthropometric measurements, body composition, blood pressure, grip strenght, and laboratory biomarkers related to cardiovascular and metabolic health. The main objective is to compare diet characteristics and cardiometabolic risk profiles across different dietary patterns, providing insights into the potential health benefits and risks associated with each dietary pattern.