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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 | Effect of Genistein in Women With Metabolic Syndrome | Completed | Metabolic Syndrome | Dietary Supplement, Dietary Supplement - genistein, placebo | University of Messina, Ministry of Education, Universities and Research, Italy, Other, Other | Female | 45 Years - 70 Years | Phase 2/Phase 3 | Interventional | The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk. | |
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Clinicaltrials.gov | Team PLAY (Positive Lifestyles for Active Youngsters) | Completed | Obesity | Behavioral - Team PLAY | University of Tennessee, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Other, NIH | 4 Years - 7 Years | Phase 2/Phase 3 | Interventional | The purpose of this study is to determine whether an intense family-centered program to help children, 4 to 7 years old, control their weight is more effective than the advise and referrals their health provider gives in the primary care office. | ||
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Clinicaltrials.gov | Reducing Television Viewing to Prevent Childhood Obesity | Completed | Obesity, Cardiovascular Diseases | Behavioral - Reducing television and other screen time (SMART curriculum) | Stanford University, National Heart, Lung, and Blood Institute (NHLBI), Robert Wood Johnson Foundation, Other, NIH, Other | N/A - N/A | Phase 2/Phase 3 | Interventional | Randomized controlled trial to test the efficacy of reducing television, videotape and video game use to prevent obesity, increase physical activity, improve physical fitness, and decrease dietary fat and calorie intake among third grade children in twelve ethnically-diverse elementary schools. | ||
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Clinicaltrials.gov | Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants | Completed | Gastroesophageal Reflux Disease, Acid Reflux, Obesity | Drug, Drug - Alginate-antacid group, Non antacid alginate group | Universiti Sains Malaysia, Other | 18 Years - 70 Years | Phase 2/Phase 3 | Interventional | A randomized, open-label study with antacid-control will be performed over 48 hours period by continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be separated into either groups according to alginate antacid group [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid [Gaviscon Advance (GA)®, Reckitt Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of antacid after taking late night standardised meals. | ||
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Clinicaltrials.gov | Effects of Zinc Supplementation on Anthropometric Factors, Apelin and Inflammatory Markers in Obese Individuals | Completed | Obesity | Dietary Supplement, Other - zinc sulfate, corn starch | National Nutrition and Food Technology Institute, Other | 18 Years - 45 Years | Phase 2/Phase 3 | Interventional | To study the effects of zinc supplement on anthropometric factors, Apelin and inflammatory markers in obese individuals, 50 obes person who referred to Diet and Nutrition clinic of Shahid Beheshti University of Medical Sciences will be randomly allocated to receive 50 mg zinc capsules or placebos for 15 weeks; both groups will be advised to adherence the investigators' diet . At the first and the end of the intervention,weight, body mass index (BMI), waist circumference, fat mass and lean body mass, concentration of zinc, albumin, hs-CRP, TNF-α and plasma apelin will be assessed and compared between groups. | ||
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Clinicaltrials.gov | Effects of Flaxseed Supplementation in Metabolic Syndrome | Completed | Metabolic Syndrome | Dietary Supplement, Behavioral - flaxseed, lifestyle modification | National Nutrition and Food Technology Institute, Other | 18 Years - 70 Years | Phase 2/Phase 3 | Interventional | To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study. | ||
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Clinicaltrials.gov | Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy | Active, not recruiting | Binge-Eating Disorder, Obesity | Drug, Other - NB medication (Naltrexone Bupropion combination), Placebo | Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - 70 Years | Phase 2/Phase 3 | Interventional | This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo. | ||
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Clinicaltrials.gov | Study of Testosterone vs Placebo in Testicular Cancer Survivors | Completed | Metabolic Syndrome, Testicular Cancer, Leydig Cell Failure in Adult | Drug, Drug - Testosterone, Placebos | Mikkel Bandak, Other | Male | 18 Years - 65 Years | Phase 2/Phase 3 | Interventional | The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease. The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency. | |
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Clinicaltrials.gov | Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome | Completed | Metabolic Syndrome | Dietary Supplement, Dietary Supplement - Chungkookjang, Placebo | Chonbuk National University Hospital, Other | 18 Years - 29 Years | Phase 2/Phase 3 | Interventional | The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure. | ||
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Clinicaltrials.gov | Healthy Eating Aerobic and Resistance Training in Youth (HEARTY) Trial | Completed | Obesity | Behavioral - aerobic and resistance exercise | Ottawa Hospital Research Institute, Canadian Institutes of Health Research (CIHR), Canadian Diabetes Association, Other, Other, Other | 14 Years - 18 Years | Phase 2/Phase 3 | Interventional | The purpose of this study is to evaluate the effects of resistance training, aerobic training, and combined aerobic and resistance training on percent body fat, measured using Magnetic Resonance Imaging (MRI), in sedentary post-pubertal overweight or obese youth aged 14-18 years. | ||
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Clinicaltrials.gov | Type 2 Diabetes Primary Prevention for At Risk Girls | Completed | Obesity, Diabetes Mellitus, Prediabetic State | Behavioral, Behavioral - Nutrition Education, After-school dance class | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | Female | 7 Years - 10 Years | Phase 2/Phase 3 | Interventional | Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls. The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke. Our Two Approaches: 1. A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity. 2. After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance. Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years. Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation. | |
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Clinicaltrials.gov | Effect of Intake of Pyrus Pyrifolia Var. Culta(Makino) NaKai Peel Extract on Body Fat and Blood Lipid. | Unknown status | Obesity | Dietary Supplement, Dietary Supplement - Pyrus pyrifolia var. culta(Makino) NaKai peel extract, Placebo | Hanyang University, Other | 19 Years - 65 Years | Phase 2/Phase 3 | Interventional | The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure. | ||
Clinicaltrials.gov | Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight | Completed | Obesity | Dietary Supplement, Dietary Supplement - Glycin max(L.) Merr. peel extract, Placebo | Hanyang University, Other | 19 Years - 65 Years | Phase 2/Phase 3 | Interventional | The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure. | ||
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Clinicaltrials.gov | LapBand Adjustment to Improve Early Weight Loss | Completed | Obesity | Device - EndoFLIP device (FDA Device Listing Number : D091203) | Crospon, Industry | 18 Years - N/A | Phase 2/Phase 3 | Interventional | Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery. | ||
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Clinicaltrials.gov | B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long) | Completed | Obesity | Drug - Metobes-compound | University of Copenhagen, Metabolife, Other, Industry | Male | 18 Years - 50 Years | Phase 2/Phase 3 | Interventional | To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin, tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be inhibited by blocking the β-adrenergic receptors. The effect of the Metobes-compound will be investigated by: 1. 5-hour energy expenditure and respiratory quotient (ventilated hood). 2. 5-h change in blood pressure and heart rate 3. 5-h change in sympathetic/parasympathetic ratio. 4. Ad libitum energy intake. 5. Self-reported postprandiel appetite sensations (VAS). | |
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Clinicaltrials.gov | Effects of Graptopetalum Paraguayense E. Walther on the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome | Completed | Metabolic Syndrome | Other, Other - Graptopetalum paraguayense E. Walther, Placebo | Chung Shan Medical University, National Science Council, Taiwan, Other, Other | 20 Years - 85 Years | Phase 2/Phase 3 | Interventional | Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and Graptopetalum paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of this study could provide the information of Graptopetalum paraguayense E. Walther supplements to what has been know in MS subjects. | ||
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Clinicaltrials.gov | Effects of Intentional Weight Loss Interventions in Chronic Kidney Disease | Completed | Chronic Kidney Disease, Obesity | Behavioral, Procedure - Diet and exercise, Bariatric Surgery | The Cleveland Clinic, Other | 19 Years - 99 Years | Phase 2/Phase 3 | Interventional | Obesity is an established risk factor for development and progression of kidney disease. Intentional weight loss in people without kidney disease results in an improvement in diabetes, blood pressure, cholesterol, cardiovascular disease and overall death rates. The investigators do not know whether this holds true in patients with chronic kidney disease. In the proposed pilot study, the investigators will analyze if kidney function stabilizes after weight loss interventions in obese kidney disease patients and the mechanisms that might mediate this beneficial effect. If weight loss in kidney disease patients results in stabilization of kidney function, this would provide an opportunity to conduct a long-term prospective study to analyze the sustained benefits of weight loss in kidney disease patients. Specific aim 1: To ascertain the effects of lifestyle modification or bariatric surgery on urinary protein excretion and renal function among obese CKD patients. Hypothesis: Weight loss attained through either lifestyle modification or surgical intervention will result in lowering of urinary protein excretion and stabilization of renal function among obese CKD patients. Specific aim 2: To identify the mechanism that mediates the change in urinary protein excretion and renal function among obese CKD patients undergoing lifestyle modification or bariatric surgery. Hypothesis: Weight loss attained through either lifestyle modification or surgical intervention will result in amelioration of endothelial dysfunction, inflammation, insulin resistance and an increase in High Molecular Weight (HMW) adiponectin levels that then mediate the improvement in urinary protein excretion and renal function among obese CKD patients. | ||
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Clinicaltrials.gov | Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study | Completed | Obesity | Behavioral, Behavioral - More-Intensive, Less-Intensive | University of Pittsburgh, Milton S. Hershey Medical Center, United States Department of Defense, Other, Other, U.S. Fed | 18 Years - 80 Years | Phase 2/Phase 3 | Interventional | Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives. The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD). | ||
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Clinicaltrials.gov | A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program | Completed | Obesity | Behavioral, Dietary Supplement - Weight loss counseling, Portion-Controlled Foods | Kaiser Permanente, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | 18 Years - N/A | Phase 2/Phase 3 | Interventional | We hypothesize that individuals provided with 1 meal per day of portion-controlled foods (shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals per day of portion-controlled foods. The study is designed to assess whether equal weight loss can be achieved at a lower cost to the health care system (or health care payer), with patients contributing some of the cost of their own treatment. | ||
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Clinicaltrials.gov | The Effects of Butyrate on Children With Obesity | Unknown status | Insulin Resistance, Obesity | Dietary Supplement, Other - Butyrate, Placebo | Federico II University, Other | 7 Years - 15 Years | Phase 2/Phase 3 | Interventional | Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal level, including: immune regulation with anti-inflammatory effect at intestinal and systemic level and modulation of gut microbiota. Many of these effects result from an epigenetic mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that butyrate can exercise very effective protective action against obesity through the stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced by HFD, that butyrate is effective in preventing and treating obesity and insulin resistance. After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight, 30% of fasting glucose and 50% insulin resistance. In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated that the administration of butyrate is able to significantly reduce insulin resistance, liver damage, dyslipidaemia through a modulation of the inflammatory process. Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral administration. All of these data makes plausible a possible positive effect on insulin resistance in the obese child. |
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