Clinical Research Directory

The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults

Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365')

To demonstrate the safety and efficacy of Orbera365 in obese populations to support the registration of Orbera365.

OverStitch NXT Endoscopic Suture System

To demonstrate the safety and efficacy of OverStitch NXT Endoscopic Suture System for endoscopic sleeve gastroplasty（ESG） in obese populations to support the registration of OverStitch NXT for ESG indication.

Simplifying Diet Tracking in a Digital Weight Loss Intervention

The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss. The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1, 6, 12, and 18 months.

A Study to Evaluate a Supplement Combination in Supporting Weight Loss, Metabolic Health, and Quality of Life

This consumer-use study evaluates the effects of a combined postbiotic and prebiotic supplement regimen on appetite control, cravings, metabolic health, energy, and quality of life in adults aged 18-65 years with a body mass index (BMI) between 25 and 30. Participants will consume one capsule of resM™ GLP-1 Postbiotic and one scoop of resG prebeet ENERGY Prebiotic daily for 60 days. Data will be collected through daily check-ins, weekly surveys, and quality-of-life questionnaires administered through the Chloe mobile application. The primary objective is to evaluate changes in appetite control and food cravings over 60 days of supplementation.

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time. Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds. Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly. After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS.

Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass. Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers

Approximately 42% of American adults are obese, and this condition is strongly related to the development of colorectal cancer. Innovative lifestyle strategies to treat obesity and reduce colorectal cancer risk are critically needed. This research will demonstrate that time-restricted eating, a type of intermittent fasting, is an effective therapy to help obese individuals reduce and control their body weight and prevent the development of colorectal cancer.

Effects of Ramadan Fasting With Exercise on Cardiometabolic Health

The goal of this interventional study is to examine the effects of Ramadan diurnal fasting alone and in combination with moderate-intensity aerobic exercise on cardiometabolic health in adults with overweight and obesity. The main questions it aims to answer are: 1. Does Ramadan diurnal fasting lead to changes in body composition and cardiometabolic health outcomes? 2. Does adding moderate-intensity aerobic exercise during Ramadan fasting result in greater improvements in cardiometabolic health compared with fasting alone? Participants will be randomly assigned to one of two groups: Ramadan diurnal fasting only or Ramadan diurnal fasting combined with a supervised moderate-intensity aerobic exercise program. Cardiometabolic, metabolic, and behavioral outcomes will be assessed before Ramadan and during the last week of Ramadan.

GLP-1 Medication & Behavioral Health Programs on Weight & Metabolic Outcomes: FLOURISH and THRIVE Prospective Cohort Study

This research program includes two coordinated prospective studies (FLOURISH and THRIVE) evaluating the real-world effectiveness of Noom's digital health programs on weight, cardiometabolic biomarkers, physiological health indicators, and program engagement. FLOURISH is a 6-arm prospective cohort study comparing an Education-only control, Noom Weight, standard-dose compounded semaglutide, microdose compounded semaglutide, standard-dose tirzepatide (Noom Plus), and microdose tirzepatide (Noom Plus Microdose). THRIVE is a nested 2-arm prospective study comparing a Proactive Health program to a Noom Free Tier control. Participants complete monthly surveys, remote biomarker collection (Tasso device), connected-scale weigh-ins, and in-app biometric assessments (FaceScan, BodyScan). Microdose and Free Tier arms also use wearable fitness trackers. Primary outcomes are changes in cardiometabolic biomarkers, weight, body composition, and GLP-1 side effect profile. Total N = 2,310; 24-month duration.

Effects of Exercise and Short Term Rapid Weight Loss on Whole Blood Cells and Lymphocyte Subsets in Highly Trained National Level Wrestlers

Wrestling is a weight-classified sport in which athletes frequently apply rapid weight loss (RWL) strategies prior to competition. While the performance-related consequences of RWL have been widely investigated, its combined effects with exercise on hematological parameters and immune cell profiles remain insufficiently understood. Therefore, this study aims to examine the effects of short-term weight loss and exercise on whole blood cell parameters and lymphocyte subsets in elite wrestlers. Nine elite male wrestlers actively competing in the senior category (mean age: 22.90 ± 5.15 years; mean height: 1.75 m) voluntarily participated in this study. Athletes will achieve an average body mass reduction of 4.3% over a five-day period. Venous blood samples will be collected at 09:30 a.m. in a fasted state during two experimental phases: (1) Exercise-only phase, with blood sampling before and after exercise (BRWL1 and BRWL2); (2) Exercise plus weight loss phase, following the five-day weight loss period, with blood sampling before and after exercise (ARWL1 and ARWL2). Complete blood count parameters will be analyzed using an automated hematology analyzer, while lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, CD16/56+) will be assessed by flow cytometry. Statistical analyses will be performed with a significance level set at p \< 0.05.

Metabolic Health, Bones and Nuts During Weight Loss in Adults

The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.

The Effect of Weight Loss on Bone in Men

The purpose of this study is to determine the effect of weight loss on bone health in men.

The Effect of Weight Loss and Dietary Protein Intake on Bone

The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. We will also examine how two levels of protein intake affects diet quality.

Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)

The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen

The study is a single site parallel randomized controlled study. The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m\^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight and adiposity and its complications compared to a control group. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 12 months.

Testing a Tailored Approach to Long-Term Weight Loss Success

The purpose of this study is to develop and test an adaptive, individually tailored intervention to prevent weight regain in people who have intentionally lost weight. The main questions it aims to answer are: * Is an adaptive intervention with tailored re-engagement support feasible for individuals following intentional weight loss? * Does this intervention prevent weight regain after intentional weight loss? Participants will: * Complete a baseline assessment of body measurements * Complete surveys on dietary intake, mental health, and physical activity Participants will also engage in a 26-week program, which involves: * Receive regular educational texts/emails * Fill out weekly online survey check-ins * Weigh themselves at least weekly on a scale provided by the study * Some participants may receive health coaching during portions of the study. * Assessments will be repeated for all participants at the end of the intervention period.

Time Restricted Eating (TRE) and High-Intensity Interval Training (HIIT) to Improve Health in Patients With Metabolic Syndrome (METS)

Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and cardiometabolic health markers in the absence of caloric restriction. Limited research in subjects with metabolic syndrome (MetS) suggests that this feeding paradigm may also apply to human health when combined with an exercise training program, but more research is needed to confirm this hypothesis. This project will determine the independent and combined effects of high-intensity interval training and time-restricted eating on cardiometabolic factors among overweight or obese patients with MetS. The intervention period will be sixteen weeks. Before and after the intervention, MetS components (i.e., MetS Z score), body composition, and physical fitness will be measured and compared between groups who are doing either high-intensity interval training, time-restricted eating, both high-intensity interval training and time-restricted eating, or who are in a control group. Physical activity, diet, sleep quality, and intervention adherence will also be measured.

Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.

Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Lorcaserin in Obesity: Identification of CNS Targets Using fMRI

The purpose of this protocol is to investigate, using functional magnetic resonance imaging (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's downstream metabolic effects.

Dyad Plus Effectiveness/Feasibility

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function

Changes in adipose tissue biology are now recognized as a key factor underlying the increased risk of metabolic and cardiovascular disease with obesity. Clinical interest in adipocyte-derived extracellular vesicles (Ad-EVs) has intensified due to their potential as circulating biomarkers of adipose tissue health and systemic messengers, regulators and mediators of cardiometabolic health and disease with obesity. The investigators hypothesize that elevated Ad-EVs in adults with obesity will be negatively associated with endothelium-dependent vasodilation. Furthermore, the investigators hypothesize that in adults with obesity, intentional weight loss-induced reduction in circulating Ad-EVs is associated with greater endothelium-dependent vasodilation.

Changes in Taste and Eating Habits Associated With GLP-1 Agonists in Weight Loss Patients

This observational retrospective study aims to evaluate changes in taste perception, eating habits, and behavioral aspects in adults treated with GLP-1 receptor agonists for weight loss. Participants include adults aged 18-60 receiving treatment at specialized nutrition centers in Italy. Data are collected from clinical records, dietary questionnaires, and metabolic assessments before and after at least 12 weeks of GLP-1 agonist treatment. The study's primary goal is to understand how these treatments affect food preferences and taste perception. Secondary outcomes include changes in body weight, body composition, gastrointestinal side effects, and treatment adherence. All data are anonymized and collected according to ethical guidelines.