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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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Clinicaltrials.gov | Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African Americans Study (GENE-FORECAST): Sodium Intervention Trial (SIT) | Recruiting | Cardiovascular Disease | Other, Other - SODIUM CHLORIDE, placebo | National Human Genome Research Institute (NHGRI), NIH | 21 Years - 65 Years | Early Phase 1 | Interventional | Background: Hypertension is a risk factor for heart disease. Low-sodium diets rich in fruits, vegetables, and other healthy foods are a good way to reduce blood pressure in people with hypertension. Researchers want to learn more about why African Americans seem to have the greatest benefit from certain dietary interventions. Objective: To better understand the body s response to adding more salt to the diet. Eligibility: U.S.-born African American adults ages 21 to 65 who are in good general health and took part in the GENE-FORECAST. Design: Participants will be screened with a medical history and physical exam. If needed, they will take a pregnancy test. These tests will be repeated during the study. Each day for 2 weeks, participants will take 3 capsules that contain either placebo or salt. Then they will take no pills for 3 weeks. Then they will take placebo or salt capsules for 2 more weeks. Participants will talk about the foods and drinks they have consumed over the past 24 hours. They will take a survey about their physical activity and sleep. Participants will complete taste tasks to obtain their responses to sweetness or saltiness. Sucrose and salt detection thresholds and preferences will be assessed. Participants will give blood and urine samples. Saliva samples will be collected from their mouth by passive drool or by spitting into a sterile tube. Skin samples will be collected from behind their ears and the inner part of their elbow, using sterile swabs. Participants will get kits to collect stool samples at home. Participants will have 4 study visits over 7 weeks. | ||
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Clinicaltrials.gov | Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery | Active, not recruiting | Obesity | Procedure, Drug, Drug - Oral Glucose Tolerance Test (OGTT), Human Ghrelin, Saline | Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 21 Years - 65 Years | Phase 1 | Interventional | The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin. | ||
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Clinicaltrials.gov | Goal Directed Versus Conventional Weight Loss Program | Unknown status | Obesity | Other, Other - Conventional Program, Goal-directed Program | National University Hospital, Singapore, Other | 21 Years - 65 Years | N/A | Interventional | The aim of our study is to determine if the goal directed weight loss program improves weight loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy. | ||
Clinicaltrials.gov | Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese | Terminated | Type 2 Diabetes, Obesity | Device, Procedure - EndoBarrier, Sham Procedure | GI Dynamics, Industry | 21 Years - 65 Years | N/A | Interventional | To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes | ||
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Clinicaltrials.gov | RCT to Describe the Effects of Colon Delivered Acetate, Propionate and Butyrate on Satiety and Glucose Homeostasis | Completed | Obesity, Overweight | Dietary Supplement, Dietary Supplement, Dietary Supplement - Inulin acetate ester, Inulin propionate ester, Inulin butyrate ester | Scottish Universities Environmental Research Centre, NHS Greater Clyde and Glasgow, University of Glasgow, Other, Other, Other | 21 Years - 65 Years | N/A | Interventional | Obesity, with its associated co-morbidities, is a major public health challenge. It is estimated that by 2050, 60% of men and 50% of women will be clinically obese. Obesity is associated with increased risk of developing diabetes, cardiovascular disease, and certain cancers. The increasing epidemic of obesity has necessitated the study of the complex mechanisms underlying energy homeostasis. Food intake, energy balance and body weight are tightly regulated by the hypothalamus, brainstem and reward circuits, on the basis both of cognitive inputs and of diverse humoral and neuronal signals of nutritional status. Several gut hormones, including glucagon-like peptide-1 (GLP-1) and peptide YY3-36 (PYY), have been shown to play an important role in regulating short-term food intake. Peripheral administration of PYY or GLP-1 enhances satiety and reduces food intake in animals and man. PYY, GLP-1 along with a host of other hormones are produced by the gut in response to nutrient availability in different regions of the gut and provide an exquisite mechanism of nutrient sensing in response to dietary intake. These hormones therefore represent potential targets in the development of novel anti-obesity treatments. A novel and attractive strategy to induce appetite regulation is the enrichment of foods with components that stimulate the release of GLP-1 and PYY. The short chain fatty acids (SCFA) produced by microbial fermentation of dietary fibre in the colon have been shown to stimulate the release of PYY and GLP-1 from rodent enteroendocrine L cells, via stimulation of the G-protein coupled free fatty acid receptors (FFAR) on colonic L cells. However, it is not known whether the three SCFA, acetate, butyrate and propionate, differentially affect appetite and glucose control. The aim of this study is to compare the effects of increased colonic delivery of acetate, butyrate and propionate on appetite and glucose control in overweight men in a randomised crossover study. | ||
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Clinicaltrials.gov | Reducing Snack Variety in Weight Loss Treatment | Completed | Obesity | Behavioral, Behavioral - Standard, Limited Variety | The Miriam Hospital, National Institutes of Health (NIH), Other, NIH | 21 Years - 65 Years | N/A | Interventional | The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Although decreasing portion sizes is a strategy used in weight loss programs, research has not studied the effects of decreasing dietary variety. Cross-sectional studies show a positive association between variety and body weight and in our own studies the investigators have shown that greater reductions in the number of different snack foods (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake and greater weight loss. Limiting variety may reduce intake through long-term sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary approach with the potential to improve long-term weight loss, which has not been studied as a clinical strategy in obesity research. The objective of this application is to conduct a randomized controlled trial of a behavioral weight loss intervention limiting the number of different snack foods consumed. Two hundred overweight and obese participants will be randomized to a standard behavioral intervention (Standard) or to a standard behavioral intervention that also limits the number of different snack foods consumed (Limited Variety). Both conditions will receive an 18-month standard behavioral intervention, using behavioral techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited Variety condition will also limit variety in snack foods to only two chosen snack foods throughout the intervention. Measures of weight, snack food consumption and hedonics, and diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will determine: 1. if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months; 2. if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition; 3. if limiting snack food variety produces long-term sensory-specific satiety and/or monotony. Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake. To date, there is no dietary prescription that has been tested that capitalizes on the effect of variety on intake that can be maintained. This will be the first investigation to examine methods of manipulating dietary variety that can be adhered to over time and that influence intake, weight loss, and weight loss maintenance. | ||
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Clinicaltrials.gov | The "Metabolically-obese Normal-weight" Phenotype and Its Reversal by Calorie Restriction | Completed | Glucose Metabolism Disorders, Obesity, Visceral, Obesity, Endocrine, Insulin Sensitivity/Resistance | Behavioral - Calorie restriction | Clinical Nutrition Research Centre, Singapore, Other | 21 Years - 65 Years | N/A | Interventional | The prevalence of overweight and obesity in Singapore is approximately half of that in the United States, yet the incidence of type 2 diabetes is similar, and is expected to double in the near future. This indicates that metabolic dysfunction, particularly insulin resistance, is widely prevalent even among individuals who are considered normal-weight or lean by conventional measures, i.e. body mass index (BMI) and percent body fat. These individuals are often referred to as "metabolically-obese normal-weight" (MONW), and have increased risk for cardiometabolic disease despite their normal BMI and total body fat values. The prevalence of the MONW phenotype varies across populations and differs markedly among different ethnicities. However, our understanding of the complex interactions between ethnicity, body composition, and metabolic dysfunction and its reversal remains rudimentary. Previous attempts to characterize the MONW phenotype are confounded by the small but significant differences in BMI or percent body fat between groups (even if all subjects were lean, within the "normal" range), with MONW subjects being always "fatter" than the corresponding control subjects. There are no published studies that prospectively recruited groups of metabolically healthy and unhealthy lean individuals matched on BMI and percent body fat. Furthermore, although weight loss improves body composition and many of the cardiometabolic abnormalities in most obese patients, little is known about the possible therapeutic effects of calorie restriction in MONW subjects. Accordingly, a better understanding of the MONW phenotype and the evaluation of therapeutic approaches for its reversal will have important implications for public health. By facilitating earlier identification of these subjects, who are more likely to go undiagnosed and thus less likely to be treated before clinically overt cardiometabolic disease develops, results from this study will allow for earlier and effective intervention. | ||
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Clinicaltrials.gov | The Relationship of TV Viewing to Energy Balance in Adults | Completed | Obesity, Overweight | Behavioral, Behavioral - No TV viewing reduction, TV viewing reduction | University of Vermont, United States Department of Agriculture (USDA), Other, U.S. Fed | 21 Years - 65 Years | N/A | Interventional | The specific objectives of this project are to: 1. Investigate the effects of reducing TV viewing time on energy intake, eating behavior, and energy expenditure in overweight or obese adult subjects, thus providing a basis for evaluating if reducing TV viewing time might be a useful adjunct therapy in obesity prevention and treatment 2. Analyze the types of foods eaten in conjunction with TV viewing 3. Determine if there is an association between location of TV and BMI. | ||
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Clinicaltrials.gov | A Cafeteria Based Study of Weight Gain Prevention | Completed | Obesity, Overweight | Behavioral, Behavioral - REDE, control | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | 21 Years - 65 Years | N/A | Interventional | The dramatic rise in overweight and obesity during the past several decades can be explained by environmental changes that foster increased energy intake and decreased energy expenditure. There are several reasons to suggest that the most effective approach to weight gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering the energy density of the diet. Our energy density manipulations will be designed to reduce both the fat content and the caloric density of foods served at a cafeteria, which serves as the "food environment" for hospital employees. | ||
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Clinicaltrials.gov | Effectiveness of Behavioral Treatments for Obesity and Major Depression in Women | Completed | Depression, Obesity | Behavioral, Behavioral, Behavioral - Weight loss treatment, Behavior therapy for depression, Health education counseling | University of Massachusetts, Worcester, National Institute of Mental Health (NIMH), Other, NIH | Female | 21 Years - 65 Years | N/A | Interventional | This study will compare the effectiveness of two weight loss programs, one supplemented with health education and the other supplemented with behavioral counseling, in treating women who are depressed and overweight. | |
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Clinicaltrials.gov | To Study Different Levels of MK0493 for Safety, Efficacy, and Tolerability in Obese Patients (0493-017)(COMPLETED) | Completed | Obesity | Drug - MK0493 | Merck Sharp & Dohme Corp., Industry | 21 Years - 65 Years | Phase 2 | Interventional | To study different doses of MK0493 for safety, efficacy and tolerability in obese patients. | ||
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Clinicaltrials.gov | Brief Behavioral Weight Loss Treatment vs. Weight Watchers | Completed | Obesity, Overweight | Behavioral, Behavioral, Behavioral - Weight Watchers, brief behavioral weight loss treatment, brief behavioral + Weight Watchers combined treatment | The Miriam Hospital, Other | 21 Years - 65 Years | N/A | Interventional | The purpose of this study is to compare the effectiveness of Weight Watchers, brief behavioral treatment, and a combination treatment. We hypothesize that a combination treatment will achieve greater weight losses than Weight Watchers alone. | ||
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Clinicaltrials.gov | Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction | Completed | Obesity | Behavioral, Behavioral - low carbohydrate diet, low carbohydrate diet and exercise | University of Surrey, British Heart Foundation, Other, Other | Male | 21 Years - 65 Years | N/A | Interventional | The purposes of this study are: To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat. To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men. | |
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Clinicaltrials.gov | Time and Dose Evaluation of Stearidonic Acid (SDA) to Eicosapentaenoic Acid (EPA) in Red Blood Cells | Completed | Sudden Cardiac Death, Sudden Cardiac Arrest, Cardiovascular Disease | Dietary Supplement, Dietary Supplement, Dietary Supplement - Safflower Oil, EPA, SDA | Solae, LLC, Provident Clinical Research, Industry, Other | 21 Years - 65 Years | N/A | Interventional | The purpose of this study is to assess the relationships between dose and time of consumption of stearidonic acid (SDA) and eicosapentaenoic acid (EPA) on EPA enrichment of red blood cell (RBC) membranes in men and women. | ||
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Clinicaltrials.gov | Comparison of Weight Loss Induced by Bariatric Surgery vs Conventional Treatment | Unknown status | Obesity | Behavioral, Other, Procedure, Procedure - Lifestyle Changes, Adjustment of oral antidiabetics/insulin therapy, Laparoscopic sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass | Clinica Universidad de Navarra, Universidad de Navarra, Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria, Other, Other, Other | 21 Years - 65 Years | N/A | Interventional | Patients with overweight or obesity are in need to loose weight and represent a particularly challenging medical condition. Undoubtedly, any intervention achieving a negative energy balance over an extended time period will result in weight loss. Although several treatment modalities are available, currently the most extended approaches are lifestyle changes, pharmacotherapy, and bariatric surgery. Given the limited approved anti-obesity drugs, the main therapeutic strategies involve either conventional treatment or bariatric surgery. Conventional weight-reduction programs pursue a safe weight loss rate of 0,5-1,0 kg per week. The main modifiable factors affecting energy balance are dietary energy intake and energy expended through physical activity. In spite of the difficulty in achieving relevant and sustained weight loss via the conventional approach, some patients are successful in reducing weight and obesity-associated complications. Bariatric surgery has proved to be the most effective long-term treatment for weight loss and comorbidity improvement. While some of the surgery-induced benefits are directly dependent on adipose tissue reduction, others are due to specific gastrointestinal changes that take place early on and before any significant effects on body weight are observed. The present study contemplates the determination and comparison of the anthropometric and metabolic changes produced by the conventional and surgery-induced treatment modalities. Particular emphasis will be placed on the potential differential effects between conventional and surgical weight loss on body composition changes, circulating adipokines and gastrointestinal hormones together with their subsequent impact on cardiometabolic risk factors. | ||
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Clinicaltrials.gov | Pemf Therapy for the Management of Diabetes in Obese Patients | Recruiting | Obesity, Type 2 Diabetes | Device, Device - Pulsed Electromagnetic Fields, Sham Therapy | National University Hospital, Singapore, National University, Singapore, Other, Other | 21 Years - 65 Years | N/A | Interventional | The Investigators previously developed pulsed electromagnetic field stimulation therapy (PEMF) for the metabolic activation of muscle and adipose tissues. In vitro and in vivo preliminary data from rodents demonstrate that PEMF-t induced changes reminiscent of beneficial exercise adaptations, in response to enhanced metabolic fuel utilisation. These exercise mimetic effects were achieved in the absence of exercise and its associated mechanical stresses as the rodents were sedentary. A human pilot study conducted with this platform demonstrated improved muscle function after only 5 weeks. The PROMISE pilot trial will investigate whether metabolic activation of muscle with a novel, non-invasive technology will further improve metabolic outcomes in overweight/obese patients with early T2DM who are currently given diet and/ or lifestyle interventions. | ||
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Clinicaltrials.gov | Effect of EGCG on the Body's Response to Insulin | Withdrawn | Hypertension, Obesity, Type 2 Diabetes, Insulin Resistance | Drug - EGCG | University of Maryland, Baltimore, Other | 21 Years - 65 Years | Phase 2 | Interventional | This study will examine whether epigallocatechin gallate (EGCG), a major component of green tea, affects how the body responds to insulin in healthy and obese people. Insulin is not as effective in people who are overweight, have high blood pressure or diabetes. This condition is known as insulin resistance. Laboratory studies suggest that green tea or EGCG treatment lowers blood pressure, lowers blood sugar and increases blood flow. This study will see if EGCG improves insulin resistance or insulin's effects on blood flow in people with insulin resistance. Healthy normal weight or overweight people between 21 and 65 years of age may be eligible for this study. Participants are randomly assigned to take EGCG or a placebo ( inactive dummy pill ) in two 4-week treatment phases with a 2-week period of no study medication before each treatment phase. After the first 4-week treatment, patients on placebo are switched to EGCG and those on EGCG are switched to placebo. In addition to treatment, participants undergo the following procedures during the study period: - Screening, including medical history, physical examination and blood and urine tests, and finger-stick blood sugar measurement for patients with diabetes - Complete a dietary and physical activity questionnaire and consult with a dietitian - Blood and urine tests - At-home and clinic blood pressure monitoring - Glucose clamp test to measure how the body responds to insulin. This test is done three times during the study. A needle is placed in a vein in each of the subject's arms, one for sampling blood and the other for infusing insulin, glucose and potassium. Glucose and insulin levels, electrolytes, lipids, fatty acids, cytokines and epicatechin are measured. - Forearm blood flow measurement with microbubbles and ultrasound. Before beginning the glucose clamp test, a test of how well the blood vessels relax is done. A device that measures the size of the artery in the upper arm is placed above the elbow. Blood flow in the muscle of the forearm is measured by ultrasound using a small infusion through a vein of microbubble contrast agent consisting of gas-filled bubbles the size of red blood cells. The contrast agent is infused over a 7- to 9-minute period at the beginning of the glucose clamp test and again 2 hours after the beginning of the test. | ||
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Clinicaltrials.gov | Metabolic Response Evaluation of Low-sugar Snack Bars | Recruiting | Pre Diabetes, Diabetes, Obesity | Other, Other, Other, Other, Other, Other, Other, Other - Control 1, Control 2, Standard Crokao, Low sugar variant 1, Low sugar variant 2, Low sugar variant 3, Low sugar variant 4, Low sugar variant 5 | Clinical Nutrition Research Centre, Singapore, Other | Male | 21 Years - 65 Years | N/A | Interventional | To determine the post-prandial metabolic response and biomarker response, following the consumption of newly developed low glycaemic index (GI) snack bars. The snack bars are formulated with different combinations and ratios of ingredients and food structures. The low sugar products maintaining glucose homeostasis and preventing metabolic problems may have commercial potential as a novel functional ingredient in a variety of fields, including nutrition, medicine, and agriculture. | |
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Clinicaltrials.gov | Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial | Recruiting | Obesity, Weight Loss | Drug, Behavioral - Botulinum toxin type A, Weight Management Program | Tan Tock Seng Hospital, Other | 21 Years - 65 Years | Phase 2/Phase 3 | Interventional | This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone. | ||
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Clinicaltrials.gov | PREMIER: PREvention of Metabolic Illness Through prEcision nutRition | Not yet recruiting | Obesity, Type 2 Diabetes, Metabolic Syndrome, Diet Habit, Nutritional and Metabolic Disease, Food Preferences | Other - Dietary intervention | Massachusetts General Hospital, NORCH (Nutrition Obesity Research Center at Harvard), Boston Area Diabetes Endocrinology Research Center, Other, Other, Other | 21 Years - 65 Years | N/A | Interventional | Dietary intake is a major driving force behind the escalating obesity and type 2 diabetes epidemics. Large, high-quality clinical trials have shown that close adherence to healthy dietary recommendations significantly reduce the incidence of obesity and type 2 diabetes, especially among people at increased risk. However, large inter-individual variability exists in response to dietary interventions. To inform more effective obesity and type 2 diabetes prevention strategies, it is crucial to better understand the biological, environmental, and social factors that influence how people interact and respond to specific foods. In a recent large-scale genome-wide association study, our research team has identified 96 genomic regions associated with overall variation in dietary intake. This study provided evidence that inherited molecular differences are likely to impact on food intake (i.e., preference for certain foods) and metabolic homeostasis (i.e., glucose regulation). Connecting knowledge about human genetic variants with information from circulating metabolites can be particularly useful in understanding the mechanisms by which some people experience a detrimental response to specific foods. The specific objective of the PREMIER study is to carry out an interventional dietary study to measure the response of blood glucose and other biomarkers to a standardized meal, and evaluate the extent to which food choices differ among individuals with distinct genetic susceptibility. |
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