Clinical Research Directory

Can Gut Bacteria Predict Who Benefits Most From Exercise? A Gut Supplement to Help Exercise Non-Responders

Overview: You are invited to participate in a research study. You can join if you are a woman, 18-40 years old, have a BMI \>25, and a regular menstrual cycle (every 24 to 38 days, per the Cleveland Clinic). This study is open to the TCU and non-TCU communities. You cannot join if you: * Have diagnosis of diabetes or take insulin or metformin. * Have either diagnosis of high blood pressure, is currently taking high blood pressure medications, or shows high blood pressure readings during visit 1 ≥130/80 mmHg. * For the past month, have engaged in \>150 min/week of moderate intensity aerobic exercise (brisk walking), \>75 min/week of vigorous-intensity aerobic activity (running, fast cycling), and ≥1 session/week of strength exercising using weights for the past month. * Have lost or gained 10% or more of your body weight in the past 3 months. * Have used antibiotics or probiotics in the past 3 months. * Follow a restrictive diet like vegetarian, vegan, keto, or carnivore. * Take weight loss medications or supplements. * Smoke (including vaping) or drink heavily (more than 8 drinks per week for women, per CDC guidelines). Study Details: This study is being conducted at Texas Christian University, Richel building 256 and 259. The project is sponsored by a Texas Christian University Invests in Scholarship grant. The purpose of this study is to looks at how gut bacteria affect exercise benefits. We want to see if a supplement called butyrate can help people who don't get better insulin response from exercise. Butyrate is a natural substance made by gut bacteria when they break down fiber in your diet. The study lasts 12 weeks, including a 12-week supervised exercise program (30-60 min per day/5 days per week), 4 weeks of taking a butyrate supplement daily (weeks 8 to 12), 3 material pick up visits (10 min each) and 3 lab visits (60 min each). All participants will follow the 12-week exercise intervention and all participants will follow the 4-week supplementation. Participants: You are being asked to take part because you're a woman aged 18-40 with a BMI of 25.0 or higher and have regular menstrual cycle (every 24 to 38 days, per the Cleveland Clinic). You must not have done regular exercise (less than 150 minutes of moderate activity, 75 minutes of intense activity, or 1 session of strength training per week) for the past month and have no recent competitive sports experience. If you decide to be in this study, you will be one of 40 participants in this research study at TCU.

Sanctuary Farm Prescription in Adolescents

The goal of this research study is to learn if an 8-week produce prescription program (in partnership with a local urban farm) can increase fruit and vegetable consumption in overweight teens and improve their blood pressure and weight. The main questions are: * Is a produce prescription program in overweight teens feasible? * Will a produce prescription with educational videos increase weekly fruit and vegetable intake? * Will a produce prescription with educational videos improve blood pressure and weight for height? Researchers will compare the teens' fruit and vegetable intake, blood pressure and weight for height before and after the produce prescription. Researchers will also see how feasible it is by measuring the number of produce prescriptions are picked up by the families and how many educational videos are viewed. Participants will: * complete questionnaires related to their diet and nutrition * measure their blood pressure and weight at the beginning and end of the study * obtain weekly produce prescriptions

UBT251 Injection Phase II Study (Overweight or Obesity)

This randomized, double-blind, parallel, placebo-controlled phase II study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients

Soup and Bread Recipe Impacts on Ingestive Behavior

The goal of the study is to determine the likability of seeds incorporated into lunch foods. The study will provide a better understanding of ways to make recipe alterations that may promote health and fullness.

HealthyWE: Achieving a Healthy Weight and Reducing Pain

The goal of this project was to reduce and manage obesity and increase self-efficacy for keeping a healthy weight and improve pain, quality of life, and mental health symptoms among 60 adults aged 19 and older in Camden City, New Jersey. The City of Camden has an adult obesity rate of 44.1%. Obesity and aging are significant contributing factors to increased utilizations of healthcare services. Obesity is a major risk factor for non-communicable illnesses such as cardiovascular disease, type 2 diabetes, hypertension, dyslipidemia, pain, and mental health. Physical activity is effective in reducing and managing obesity. However, personal barriers (e.g., lack of time for physical activity, physical capability to perform physical activities, competing demands), built environment (e.g., safe spaces for physical activities), climate changes (e.g., heat waves and extreme weather which prevent outdoor physical activities), and systematic barriers (e.g., intervention availability) hamper obesity prevention and management in older adult population. To help older adults keep a healthy weight, our team has adapted and delivered the effective person-centered integrative interventions: HealthyWE: Keeping a Healthy Weight program to older adults in Camden New Jersey. Completion of the project will build a strong community capacity in Camden to sustain a community effort to reduce obesity and pain.

Postoperative Opioid Consumption in Gastric Sleeve Surgery

The study aimed to compare balanced anesthesia protocols using only opioids as analgesics during induction in gastric sleeve surgery with protocols using opioids and ketamine together in terms of anesthesia management, opioid side effects, and postoperative analgesia.

Effect of a Dietary Supplement on Hormones Involved in Appetite Regulation in Overweight and Obese Adults

Obesity is a chronic condition linked to numerous health risks and affects more than one billion people worldwide. While pharmacological treatments such as incretin-based therapies are available, they may have side effects, are not suitable for all patients, and adherence can be limited. Dietary supplements that influence appetite and satiety may represent an alternative or complementary approach. This study will evaluate whether a dietary supplement containing plant extracts stimulates the intestinal incretin response. The primary focus is the effect on glucagon-like peptide-1 (GLP-1) secretion. Secondary outcomes include dipeptidyl peptidase-4 (DPP-4), gastric inhibitory peptide (GIP), and insulin, as well as measures of appetite, satiety, food intake, and anthropometrics. The trial is designed as a 12-week, double-blind, randomized, placebo-controlled parallel-group study in adults with overweight or obesity (BMI 25-40, age 18-50). Participants will receive either the dietary supplement or placebo. Blood samples will be collected at baseline and after 12 weeks, both fasting and following capsule intake and a standardized liquid meal. Anthropometric measurements and visual analog scales (VAS) for hunger and satiety will also be assessed.

Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is a community-based research project led by the Marymount University Center for Optimal Aging (MCOA). The study is designed to help older adults in the Washington, D.C., Maryland, and Virginia (DMV) area maintain independence, mobility, wellbeing and brain health as they age. Adults aged 50 years and older will receive a comprehensive health assessment at the study site, Center for Optimal Aging- ALOHA Lab at Marymount University (MU) Ballston Campus in Arlington, Virginia. The assessment includes physical and cognitive testing, health and medical history, lifestyle surveys, and biometric measures such as blood pressure, grip strength, body composition by the InBody system, balance and gait speed. Participants will receive their results in a personalized "Health Passport," which summarizes findings and provides tailored recommendations to help manage modifiable health risk factors-such as those linked to Alzheimer's disease, cardiovascular disease, frailty syndrome, and depression. Participants will return annually for up to 5 years to repeat assessments and receive updated health and wellness recommendations. The study will track changes in health over time and explore the impact of the Health Passport on health behaviors, functional independence, and quality of life. ALOHA will also evaluate the cultural appropriateness of the Health Passport for diverse populations in Northern Virginia. The program incorporates an interprofessional research model, engaging researchers from multiple health professions to work alongside older adults, supporting both participants' wellness and optimal aging.

Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer

The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy) improves cancer outcomes. The main questions it aims to answer is 1. Does the drug increase weight loss in rectal cancer patients with a high BMI 2. Does the drug improve response rates to chemotherapy and radiotherapy 3. Does the drug improve survival outcomes and if cancer returns Researchers will compare this drug in one group against a group of patients receiving preoperative total neoadjuvant chemoradiotherapy without the drug Patients will be required to 1\) take the GLP-1 receptor agonist drug during TNT or just having TNT alone as per standard hospital protocols Body weight will be measured at three predefined time points: 1. Baseline: Prior to initiation of semaglutide or TNT 2. Pre-TNT: Start of TNT (for the intervention arm, this is 4 weeks after semaglutide initiation) 3. Post-TNT: Within 7 days following completion of TNT and prior to definitive surgery Patients will complete their treatment and go on to have surgery as per standard methods for treating rectal cancer

Effects of Grape Consumption on the Immune-Gut Axis in Obesity

This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.

Training App for Inhibitory Control Towards Food

The aim of this project is to test the feasibility, acceptability and clinical impact of a mobile app-based intervention (FoodTraining) to strengthen food-related inhibitory control over 4 weeks, in a sample of people with eating or weight disorders (i.e. obesity, binge-eating disorder (BED), or bulimia nervosa (BN)) receiving standard outpatient treatment (i.e., treatment as usual (TAU) encompassing guided self-help or psychotherapy, pharmacological therapy or diet). The training will be offered in addition to TAU (experimental group) and compared to TAU alone (control group). Participants will complete questionnaires to measure eating behaviour, eating disorder psychopathology, symptoms of anxiety, depression and stress, social functioning and quality of life at baseline, 4 and 8 weeks. They will also complete momentary assessments using a mobile application (FoodTracker) to report on food intake along with related thoughts, emotions, and behaviours and will wear small, non-invasive sensors to track real-time fluctuations in glucose levels for 15 days. Participants will also perform a food-related go-no go task and a food-related temporal discounting task at baseline, 4 and 8 weeks. Finally, this study will pilot the use of a semi-structured interview to characterise the history of weight, the appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with eating or weight disorders.

A Prospective Randomnised Controlled Trial Comparing Overall Patient Compliance in a Bariatric Surgical Pathway Using the Standard Versus a More Intensified and Interactive Version of the "Get Ready" Smartphone Application.

The aim of this study is to assess the impact of a newly intensified digital platform following bariatric surgery. This will be measured using several questionnaires. The following objectives will be evaluated: the exact amount of weight loss achieved preoperatively with the preparatory diet; the occurrence of dumping symptoms; the assessment of quality of life (QOL); and compliance with supplement intake. By examining the impact of an enhanced digital platform, we aim to address critical questions regarding the effectiveness of improved patient support in the digital domain. Moreover, given the increasing prevalence of bariatric surgery as a therapeutic option for obesity, it is of utmost importance to identify strategies to optimize patient education and support through digital tools. This study not only contributes to the scientific understanding of digital support in bariatric care but also has important implications for the further development of the "Get Ready" application, ensuring that it remains at the forefront of providing comprehensive and patient-centered support in the evolving landscape of bariatric surgery.

The Impact of Probiotics on Bariatric Treatment Outcomes

The planned study aims to assess whether probiotics improve the quality of life in patients during the early postoperative period following sleeve gastrectomy, and whether they influence the absorption of micro- and macronutrients. Patients eligible for inclusion will have a BMI of 40 kg/m² or higher and must have successfully completed the qualification process for sleeve gastrectomy. Exclusion criteria include chronic gastrointestinal diseases, antibiotic use within 4 weeks prior to surgery, and lack of consent to participate in the study. On the day before surgery, a stool sample will be collected from each patient for microbiological analysis to assess the composition of gut bacteria. Patients will then undergo sleeve gastrectomy using a standard surgical technique. After the operation, participants will be randomized into two groups. The first group will receive probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14. These strains are deposited in the Polish Collection of Microorganisms at the Polish Academy of Sciences in Wrocław and are protected by Polish, European, and U.S. patents. The second group will receive a placebo. As part of follow-up, stool samples will be collected again one month and three months after surgery for comparative microbiological analysis.

UBT251 Injection Phase II Clinical Study (CKD)

This multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of UBT251 injection in obese/overweight chronic kidney disease (CKD) population

Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity

Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)

An Evaluation of "Growing Healthy Places: Mississauga"

The goal of this intervention study is to learn if community co-designed activities to improve diet and physical activity can impact the health of children ages 6-13 in Mississauga, Canada. The main questions it aims to answer are: 1. Do the community co-designed interventions improve health-related quality of life of children after one year and two years? 2. Do the community co-designed interventions improve the physical activity and eating behaviors of children after one year and two years? Ten intervention and 12 control schools will take part in this study. The schools were recruited from the Mississauga area using an application process. Selection and group assignment involved a multi-stage process with initial randomization followed by manual adjustment (to balance groups on key observable characteristics and respond to stakeholder concerns about spillovers and implementation feasibility). Researchers will compare students in schools that receive the interventions to students in schools that receive no interventions to see if the interventions improve health-related quality of life, increase physical activity and improve eating behaviors. Participants will: * attend participating elementary or middle schools (in either intervention neighborhoods or control neighborhoods) * complete an anonymous questionnaire about their wellbeing, physical activity, and eating behaviors at baseline, after one year, and after two years * potentially participate in school and community programs (if in an intervention school neighborhood)

Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients

This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece. Participants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation. The main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?

Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment

Obesity is a prevalent chronic disease affecting 17% of the French population. Treatment involves multiple factors, with pharmacotherapy playing an increasingly important role. GLP-1 receptor agonists (GLP1 RAs) are considered revolutionary in obesity treatment, with three approved molecules available in France: liraglutide, semaglutide, and tirzepatide. These treatments, combined with a healthy lifestyle, induce significant weight loss: 9% with liraglutide, 15% with semaglutide, and 20% with tirzepatide. The most common adverse events (AEs) associated with GLP-1 RAs are gastrointestinal (GI) disorders, including nausea, vomiting, diarrhea, and abdominal pain. These AEs are dose-dependent and often decline over time. In phase 3 trials, semaglutide 2.4 mg showed higher rates of GI AEs compared to placebo, but most were mild to moderate and transient. GI AEs led to dose reduction or temporary treatment interruption in 12.5% of participants, with few permanent discontinuations. Probiotics, are live microorganisms that benefit the host by improving gut microflora. Probiotics has been clinically proven to benefit gastrointestinal health. Probiotics may reduces symptoms of irritable bowel syndrome (IBS), improves gut barrier function, reduces inflammation, and decreases the incidence of C. difficile infection (CDI) in patients taking antibiotics. Probiotics is therefore theorized to potentially reduce GI side effects associated with GLP-1 RA treatment for obesity. Hypothesis Probiotics will prevent and limit the digestive disorders induced by GLP-1 R agonists, particularly during the dose escalation period. This would allow better digestive tolerance of the treatments, limiting the number of definitive treatment interruptions, facilitating compliance and dose escalation with a larger number of subjects at full dose and therefore with better systemic exposure to the compounds, a key factor in their effects on weight loss.

Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus

Validation of Heart Rate Monitors in Overweight and Obese Young Adults

Overweight and obesity are defined as an excessive accumulation of body fat that affects health. According to data from the World Health Organization (WHO), in 2022, there were 2.5 billion adults aged 18 years and older who were overweight, of whom 890 million were obese. In other words, 43% of adults aged 18 years and older were overweight, and 16% of them were obese. Overweight and obesity are key risk factors for various chronic diseases such as diabetes, hypertension, cardiovascular disease, and even some types of cancer. There is evidence that mortality from cardiovascular disease, and the incidence of cancer and diabetes, varies according to the amount of physical activity. In the context of high levels of sedentary time, higher levels of moderate to vigorous physical activity are recommended. There are various ways to treat overweight and obesity, the main ones usually being lifestyle changes, such as following a healthy diet and regular physical activity, as well as following pharmacological treatments. In this project, the focus will be on the fat metabolism generated during moderate physical activity. There are physical activity interventions aimed at increasing fat metabolism that may potentially reduce the symptoms of metabolic diseases such as obesity and type 2 diabetes. For this purpose, it is important to understand the factors that increase or decrease fat oxidation. Factors such as exercise intensity and duration are important to understand when determining maximum fat oxidation (FatMax). The aim is to develop comprehensive research that will generate knowledge and evidence on health issues with social impact through the evaluation of commercial technologies and innovative actions that promote the prevention, treatment, and resolution of national health problems such as obesity.

Assessment and Management of Multiple Drug Use in Elderly Chronic Disease Patients

The purpose of this observational study is to understand the impact of polypharmacy on the prognosis of elderly patients with chronic diseases. The main research question it aims to address is: Does polypharmacy affect the prognosis of elderly patients with chronic diseases? Elderly patients with chronic diseases will be asked to complete online survey questions regarding their disease prognosis over a 2-year period.

Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment

This clinical study investigates how blocking the hunger-related ghrelin receptor affects appetite and metabolism in individuals with obesity who are treated with semaglutide (a GLP-1 receptor agonist). LEAP2, a naturally occurring hormone that inhibits the ghrelin receptor, is used as the investigational compound. The objective of the study is to clarify how the ghrelin system functions when appetite is suppressed by semaglutide treatment. Participants will receive either LEAP2 or placebo during two experimental visits in a randomized, double-blind, crossover design. The investigators will assess food intake, appetite sensations, glucose metabolism, and hormonal responses. By examining the interaction between semaglutide and ghrelin signaling, the study aims to improve understanding of how multiple appetite-regulating systems interact and whether additional hunger signals remain active during GLP-1 treatment. The findings may inform the development of future treatments for individuals with obesity.

Effectiveness of a Family Support Model for Prevention and Management of Overweight and Obesity in Children 6-12 Years

The study will evaluate a coherent model of family support including school health care, primary health care and pediatric clinics. The model combines two evidence based programs: the universal "A Healthy School Start" provided to all children and their families during grade 1 and the targeted parental support program "More and Less" provided to parents of children with overweight or obesity. The hypothesis is that combining the Healthy School Start and More and Less programs in a coherent model will increase the collaboration between regional and municipal stakeholders, ensure early identification of families in need, ultimately improving prevention and treatment of childhood overweight and obesity. The aim of this study is to evaluate the implementation of a coherent model of family support provided through school and primary health care.

Behavioral Therapy and GLP-1 Analogue Effects on Binge Eating, Weight, and Coping in Obesity

This study is a clinical, longitudinal, non-randomized, prospective observational study that seeks to compare the treatment effects and safety of using GLP-1 analogues versus not using appetite suppressants during a lifestyle treatment program that includes individual consultations every fourth month and 10 weeks of CBT-E group therapy in patients with both obesity and BED. The primary objective of this study is to evaluate the impact on BED symptomatology, while the secondary objectives include examining the potential adoption of alternative harmful coping mechanisms. Additionally, the study will assess psychological well-being and weight changes and their consequent influence on obesity-associated comorbid conditions. Adult patients with coexisting obesity and BED presenting at the Obesity clinic at Haukeland University Hospital, Bergen, Norway, will be included Patients will be divided into two groups: Group-GLP1 (n = 40), who will use GLP-1 analogues, and Group-NoMED (n = 40), who will not use appetite suppressants. Both groups will otherwise follow the routine standardized patient care pathway with follow-up controls every four months and participation in CBT group therapy sessions. Changes in symptoms of BED, alternative harmful coping strategies and mental health will be recorded at baseline and 12 months using patient-reported questionnaires, as well as anthropometric and biochemical data.