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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 | Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development | Completed | Insulin Resistance, Obesity | Dietary Supplement, Dietary Supplement, Dietary Supplement - vaccenic acid enriched diet, Elaidic acid enriched diet, control diet | Institut National de la Recherche Agronomique, Other | Female | 18 Years - 50 Years | N/A | Interventional | The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects. | |
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Clinicaltrials.gov | FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor) | Terminated | Obesity | Behavioral - Feeding Study | Boston Children's Hospital, Indiana University, University of Alabama at Birmingham, Framingham State University, Baylor University, Other, Other, Other, Other, Other | 18 Years - 50 Years | N/A | Interventional | This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study. | ||
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Clinicaltrials.gov | Effects of Chromium Picolinate on Food Intake | Completed | Obesity, Atypical Depression | Drug - Chromium Picolinate | Pennington Biomedical Research Center, Nutrition 21, Inc., Other, Industry | Female | 18 Years - 50 Years | N/A | Interventional | The purpose of this study is to test the effects of chromium picolinate on food intake, food cravings, eating attitudes, and appetite. If chromium picolinate is found to have a beneficial impact on satiety and food intake, then this supplement may be an alternative or adjunctive treatment for overweight people desiring to modify their food intake. The primary hypothesis of this study is that among individuals who report being carbohydrate cravers, chromium picolinate supplementation will reduce food intake during a test lunch meal and produce greater satiety in comparison to a placebo. | |
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Clinicaltrials.gov | Trans Fatty Acids and Cardiovascular Risk Factors | Completed | Cardiovascular Disease | Dietary Supplement, Dietary Supplement - vaccenic acid enriched milk fat (VAMF) [Transfact1], hydrogenated oil | Institut National de la Recherche Agronomique, Other | 18 Years - 50 Years | N/A | Interventional | Background: Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. However, very little information is available on the effect of natural sources of TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited number of subjects. Methodology: To compare the effects of industrial and natural dietary sources of TFA, two specific test fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in TFA has been produced by modification of the cow's diet and selection of cows with the highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily energy (based on 2000 kcal/day). These two test fats have been incorporated into food items and will be provided to 46 healthy subjects under a randomised, double blind, controlled, cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses will be also to be evaluated. | ||
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Clinicaltrials.gov | Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise | Withdrawn | Cardiovascular Disease, Ischemia-reperfusion Injury, Postconditioning | Procedure - repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise | Radboud University Medical Center, Other | Male | 18 Years - 50 Years | N/A | Interventional | To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients. To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping. | |
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Clinicaltrials.gov | Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo? | Completed | Ischemia Reperfusion Injury, Cardiovascular Disease | Drug - atorvastatin | Radboud University Medical Center, Pfizer, Other, Industry | Male | 18 Years - 50 Years | Phase 4 | Interventional | To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm. | |
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Clinicaltrials.gov | Liking of Snack Foods - Sub-Study 1 | Completed | Eating Behavior, Obesity, Satiation | Behavioral - portion or unportioned food | The Miriam Hospital, Other | 18 Years - 50 Years | N/A | Interventional | Specific Aims: Environmental factors contributing to overconsumption, such as larger food portion sizes, may be contributing to the obesity epidemic. The objective of the proposed study is to examine the independent and combined effects of portion size and quantity of food on intake in normal weight males and females. Participants will be randomly assigned to one of four conditions varying in the portion size and quantity of junk food provided: small quantity of food packaged in small portions (SSP), small quantity of food packaged in large portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity of food packaged in large portions (LLP). A box containing four different junk foods, packaged according to one of the four conditions, will be given to participants to take home for three days. The total amount of food consumed from the box over the three days will be measured. It is anticipated that portion size and quantity of food, both independently and combined, will influence intake, such that larger portion sizes and quantity of food provided to participants will produce greater intake.Subject Population: We propose to recruit 60 healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal to 28. Participants will be non-smokers, unrestrained eaters, and have no known food allergies to the foods used in the investigation.Methods/Design: Participants will be randomly assigned to one of four conditions, varying in portion size (small versus large) and quantity of food provided (small versus large). A box containing four junk foods, packaged according to one of the conditions, will be provided to participants. They will be encouraged to eat as much or as little of the food as they want, but to at least taste each of the four foods over the three-day period. During this time, they will be instructed to not eat any other junk foods. At the end of the three-day period, participants will return the box with any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams and kcals consumed from the provided junk foods, will be examined between the four different conditions.Significance: If portion size and quantity are related to intake, subsequent studies will develop clinical interventions related to reducing portion size and/or quantity of food available in the household. | ||
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Clinicaltrials.gov | Olestra Containing Foods and Weight Loss and Weight Maintenance | Completed | Obesity | Behavioral, Behavioral, Behavioral - dietary education, dietary education and provided full fat snack foods, dietary education and provided fat free snack foods | Johns Hopkins Bloomberg School of Public Health, Procter and Gamble, Other, Industry | 18 Years - 50 Years | N/A | Interventional | This study will be conducted over three phases. Phase I will be a 16-week weight lass phase. Phase II will be a 52-week maintenance phase. Phase III will be a follow-up phase. We will test three diet regimens: 1) an olestra group who will receive a weight-reducing diet that includes olestra-containing products; 2) a triglyceride group who will receive the same weight-reducing diet but with foods made with triglyceride (regular fat); 3) a low-fat group will be instructed to consume a diet made of traditionally low-fat foods that ate available in grocery stores (no olestra foods). These groups will be re-randomized for the maintenance phase and again assigned to one of the three weight loss regimens described above: olestra, triglyceride, or low-fat. In the double-blinded experimental design, groups receiving olestra foods will not be informed of the nutrient contents of the foods or told what fat substitute is used in the preparation. (The consent form will state that a new fat-substitute may be used in the study foods.) During a "run-in" phase, olestra versus regular-fat food sensory and tolerance tests will be conducted. | ||
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Clinicaltrials.gov | Nutrition and Physical Activity for Obesity | Completed | Obesity, Overweight | Other - Exercise | Universidad Politecnica de Madrid, Universidad Complutense de Madrid, Hospital Universitario La Paz, Hospital Universitario Marqués de Valdecilla, Other, Other, Other, Other | 18 Years - 50 Years | N/A | Interventional | At the present time, scientific consensus exists on obesity multifactorial etiopatogenia. As well, professionals and researchers agree that the treatment must approach several scopes, such as dietetic, physical activity, pharmacologic and surgical. These two last ones should not be the first election and must be reserved for those cases of morbid obesities or in case the previous ones have failed. The combination of diet and exercise is still not sufficiently studied, in special, the addition of strength training, as we propose in this project, for which established intervention protocols do not exist, and that could suppose an additional benefit in the reduction of risk factors. Therefore, the objectives that we aim in this project are enumerated below: - To discover which are the most effective training protocols and to determine what type of exercise combined with nutrition is more appropriate for obesity intervention programs. - To establish the relationship between markers related with cardiovascular risk (adopokines and lipid profile) and the different intervention protocols proposed. - To describe the influence of nine genetic polymorphisms (selected by their relationship with the energy expense and the physical yield) on the effect of different training protocols. - To determine how important is body composition (fat mass and muscle mass mainly) in total daily energy expenditure. - To establish rules of nutritional and exercise intervention that can be applied in public and private training centers. If the proposed objectives are fulfilled, this would contribute to an improvement in patients health in long term, along with an enormous saving in public health. Therefore, the purpose of this project is to propose new lines of intervention in overweight and obese adults that, until now, little have been investigated. This way, resistance training is proposed in combination with cardiovascular training and endocrinologic treatment. It fits to emphasize that, as far as we know, it is the first project of these characteristics, that puts in touch the public and private sector (hospitals, universities and fitness area), to establish standardized relations protocols to allow a close pursuit of obese patients. | ||
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Clinicaltrials.gov | Effects of Capsimax on Appetite, Energy Intake and Blood Pressure | Completed | Obesity, Body Weight, Weight Loss, Overweight | Drug, Other - Capsimax, Energy restriction | Laval University, OmniActive Health Technologies, Other, Industry | Female | 18 Years - 50 Years | Phase 4 | Interventional | Obesity is an ongoing major public health problem in most countries of the world for which the agrifood industry still remains criticized because of the abundant offer of high sugar-lipid-energy dense foods, particularly in the fast-food sector. The resulting societal pressure on the food industry probably explains in part the efforts that have been deployed to seek natural active ingredients and to develop functional foods favorably influencing energy balance. Capsaicin is a food non-nutrient constituent that was shown to decrease appetite sensations and subsequent energy intake. The measurement of heart rate variability revealed an association between the increase in sympathetic nervous system (SNS) activity and the satiating effects induced by capsaicin. This is concordant with the observation that pre-prandial intake of capsaicin, be it in capsules or diluted in tomato juice, increased satiety and reduced energy intake. The objective of this study is to evaluate the long effects of Capsimax on appetite sensations and energy expenditure under conditions of moderate energy restriction and to evaluate the long-term effects of Capsimax on energy intake and expenditure under conditions of moderate energy restriction. | |
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Clinicaltrials.gov | The Investigation of Mechanical Properties in Obesity. | Completed | Body Fat Disorder, Obesity, Muscular Tone, Viscoelasticity | Diagnostic Test - Myotonometric assessment | Hasan Kalyoncu University, Other | 18 Years - 50 Years | N/A | Interventional | The study will demonstrate the relation between muscle tone and viscoelastic properties with the body mass index. | ||
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Clinicaltrials.gov | Dose-ranging Study of SKF7™ for Obesity | Completed | Obesity | Drug, Drug, Drug, Drug - low-dose, Middle-dose, Higher-dose, Placebo | Indonesia University, Medika Natura Sdn Bhd, Other, Other | 18 Years - 50 Years | Phase 2 | Interventional | This study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™). | ||
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Clinicaltrials.gov | A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth | Suspended | Obesity, Postpartum Weight Retention, Insulin Sensitivity | Behavioral, Behavioral - Low carbohydrate diet education, Low carbohydrate diet education with behavioral component | The University of Texas Medical Branch, Galveston, Other | Female | 18 Years - 50 Years | N/A | Interventional | The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women. | |
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Clinicaltrials.gov | Plasma Triglyceride Extraction by The Muscle | Completed | Obesity, Insulin Resistance | Drug, Drug - Insulin, NG-monomethyl-L-arginine | Mayo Clinic, American Diabetes Association, Other, Other | 18 Years - 50 Years | Phase 1 | Interventional | Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes. | ||
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Clinicaltrials.gov | Sutures vs. Staples Skin Closure After C-section in Obese Patients | Terminated | Obesity, Pregnancy | Procedure - Suture vs. staples closure method after c-section in obese women. | University of Arkansas, Other | Female | 18 Years - 50 Years | N/A | Interventional | This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery. | |
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Clinicaltrials.gov | Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy | Withdrawn | Type 2 Diabetes, Obesity | Lund University, Kalmar County Hospital, Other, Other | Female | 18 Years - 50 Years | Observational | The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase. | |||
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Clinicaltrials.gov | Craving and Lifestyle Management Through Mindfulness Pilot Study | Completed | Obesity | Behavioral - Craving and Lifestyle Management through Mindfulness(CALMM+) | University of California, San Francisco, National Center for Complementary and Integrative Health (NCCIH), Mount Zion Health Fund, Robert Deidrick Fund, Other, NIH, Other, Other | Female | 18 Years - 50 Years | N/A | Interventional | The purpose of this study is to determine whether an innovative program that combines mindfulness-based stress reduction and mindful eating practices with diet and exercise guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat distribution than a conventional weight-loss program(Diet-Ex intervention). | |
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Clinicaltrials.gov | Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury? | Completed | Cardiovascular Disease, Ischemia-Reperfusion Injury | Drug, Drug - Dipyridamole, caffeine | Radboud University Medical Center, Other | Male | 18 Years - 50 Years | Phase 4 | Interventional | The purpose of this project is to explore the interaction between caffeine and dipyridamole on ischemia-reperfusion injury in the forearm. | |
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Clinicaltrials.gov | Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2 | Completed | Postpartum Hemorrhage, Obesity | Drug - Oxytocin | Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Other | Female | 18 Years - 50 Years | N/A | Interventional | Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2. The investigators seek to find the best dose for patients with a BMI>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately. | |
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Clinicaltrials.gov | Reduce Sedentary Behavior at Work | Completed | Sedentary Lifestyle, Obesity, Cardiovascular Risk Factor | Medical College of Wisconsin, Other | 18 Years - 50 Years | Observational | Prior research suggests that sedentary behavior is detrimental to health, independent of exercise activity. Sedentary behavior is defined as behaviors that involve low levels of energy expenditure ≤1.5 metabolic equivalents (including sitting, watching TV, reading, and driving). Due to the high burden of sedentary behaviors in modern-day societies, this has potential implications for novel intervention strategies to reduce sitting (outside of regular exercise activity) and improve health. In addition, the modern workplace fosters sedentary behavior, and sedentary jobs now make up more than 80% of the workforce. The goal of this project is to implement interventions to reduce sedentary behavior at work and evaluate their impact on physiologic parameters and markers of disease. Specifically, the investigators/study team will use direct measurement of vascular endothelial function as one of our outcomes. This is important since conduit artery endothelial function, assessed by arterial flow-mediated dilation (FMD), is a powerful indicator of vascular inflammation and predictor of future cardiovascular events. |
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