Clinical Research Directory

Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting

This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: * Medical history, physical examination and laboratory studies * Questionnaires to assess eating behavior, food preferences, body composition, and activity level * Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) * Oral glucose tolerance test * Meal test to measure the response of certain hormones to food * Activity monitors to determine activity level * Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature * Free-living energy use study to measure calories burned under normal home conditions over 7 days * Fat and muscle biopsies * Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: * Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) * Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test

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. ...

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.

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.

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.

Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

This study is a single-site, pilot randomized factorial trial designed to evaluate the feasibility, acceptability, participant perceptions and preliminary effects of a multi-component behavioral intervention to support weight loss maintenance following discontinuation of GLP-1 and other anti-obesity medications. The intervention includes a standardized 10-week foundational weight loss maintenance program combined with candidate support components, including medically tailored meals, YMCA membership, and a structured mind-based program. Participants will be randomized using a 2 × 2 × 2 factorial design and followed for six months. Findings from this pilot study will inform optimization of a scalable intervention for future clinical trials.

Evaluation of Bariatric Endoscopic Antral Myotomy (BEAM) as a Treatment for Obesity

In the proposed study, we will be evaluating the effects of pylorus sparing antral myotomy alone, without concomitant endoscopic sleeve gastroplasty (ESG), on weight loss for subjects undergoing the procedure with a history of obesity. This is referred to as Bariatric Endoscopic Antral Myotomy (BEAM). To better understand treatment effects, we will track weight loss, gastric emptying with gastric emptying breath tests (GEBT), and gut hormones (i.e. ghrelin). This pilot, single-center, randomized, controlled, clinical study aims to assess the safety, tolerability, and short-term efficacy of BEAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial that could be submitted for NIH grant funding.

Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery. Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown. In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.

Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure

The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction (HFrEF) is controversial. Semaglutide has shown cardiovascular (CV) risk-reduction and impact on CV risk factors including overweight, dysglycaemia and hypertension in subjects with type 2 diabetes (T2D). The STEP-HFpEF (Semaglutide Treatment Effect in People With Obesity and HFpEF) recently demonstrated, at 1-year, to not only reduce weight considerably, but also significantly improve health-related quality of life, functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction (HFpEF). Also, the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease, including heart failure (but no T2D). Semaglutide demonstrated a 20% reduction in MACE, defined as the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. These landmark findings have important implications for clinicians -as they mean that weight loss and/or semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity. It is, however, unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction. Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss. Purpose: The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction.

Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors

This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.

The IGBallon (R) - for Use in the Treatment of Obesity

This study is a prospective, non-randomized, open-label, single-center study. The aim of this study is to assess the safety of the IGballoon in the human body. The effectiveness of the IGBalloon in relation to weight loss behaviour of the human body will also be investigated. This study will involve 20 participants who will be divided into two groups: 1. Monitoring group with 5 participants who swallow an IGBalloon. After four weeks, safety will be tested. Up to four additional IGBalloons may be ingested, if necessary, over the following eight weeks. 2. Treatment group of 15 participants receiving up to 5 IGBalloons over a period of 8 weeks as required. This group will be evaluated for efficiency of the IGBalloon. Various examinations, such as clinical examinations, blood tests, and gastroscopies will be carried out at certain follow-up points. Patients also receive dietary support for the entire duration of the study.

Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days). Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days) Other Objectives: To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days). To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).

Robotic Bariatric Database (RBD) Collaborative

With increased prevalence of obesity in the general population over the past 30 years, researchers have been focused on the development of new treatment options to achieve long-lasting weight loss. In 1991, the National Institutes of Health Conference Statement on Gastrointestinal Surgery for Severe Obesity developed a consensus stating that bariatric surgery was the most effective treatment for obesity since it is associated with good long-term results in terms of weight loss, glycemic control and decreased mortality. To collect and store clinical data related to the treatment outcomes of robotic bariatric surgery in order to develop an evidence base such that physicians can provide the best possible care to patients undergoing surgical weight loss interventions.

Healthy Eating Patterns During a Lifestyle Intervention

The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

Hepatic Energy Fluxes in NASH and NAS Patients

Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.

Cardiac Cachexia in Advanced Heart Failure

Heart failure is a condition in which the heart stops pumping effectively, causing symptoms such as breathlessness or leg swelling. It affects around 900,000 people in the United Kingdom. As our population gets older, this number will continue rise. It is a condition with poor overall survival - nearly 50% of patients die within 5 years of being diagnosed with heart failure. Cardiac cachexia is a complex condition associated with heart failure. There is general loss of muscle with or without loss of fat in cardiac cachexia. The main feature of cardiac cachexia is therefore unintentional weight loss in heart failure patients. The reason why it develops is poorly understood currently. Importantly, some studies have shown that cardiac cachexia is more likely to lead to poorer outcomes (such as death) in the patients who develop it. However, there have been no studies, to our knowledge, that look at this condition in those patients who have very weak hearts ('advanced heart failure'). The investigators are looking to clarify how common cardiac cachexia is within advanced heart failure patients, and secondly how outcomes compare to those advanced heart failure patients that do not have the condition. With this in mind, the investigators will be able to establish the fuller impact cardiac cachexia has on survival and outcomes in patients with advanced heart failure. This study will involve assessing a group of \~200 advanced heart failure patients for cardiac cachexia to establish an estimate of how common it is overall. The investigators will then follow up the patients over a year, to see if we can assess the impact of cardiac cachexia on survival and outcomes. Overall, the investigators therefore hope this study will give a more robust picture on the true impact of cardiac cachexia in advanced heart failure. By doing so, the investigators will firstly highlight its importance to other clinicians who will better be able to monitor and or diagnose it, and secondly pave way for more research on a potential treatment strategy for this condition.

Exercise Effects on Adipose Tissue Structure and Function

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

The Impact of Salmon Protein Hydrolysate (SPH / ProGo®) Supplementation on Hematologic and Metabolic Health

Healthy, overweight males and females randomised to receive 8-weeks of salmon protein hydrolysate SPH (12g daily) or whey protein isolate (12g daily) to assess the impact on red blood cell and ferritin levels, blood glucose levels, BMI, percent body fat and lean body mass along with hair, skin and nail health and blood biomarkers of inflammation.

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.

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

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.

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.