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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 | Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome | Completed | Obesity | Dietary Supplement, Dietary Supplement - Synergy 1, maltodextrin | Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Other | Female | 18 Years - 65 Years | N/A | Interventional | Obesity is constantly increasing, causing an important risk to develop diseases such as heart disease, diabetes,... Some recent studies have shown that obese people present modifications of colon microflora and a low-grade inflammation. In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake, body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans are also able to restore the microflora disturbed by a high fat diet and to prevent endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al, Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in healthy human. An intervention study in obese patients is thus needed to study the effects of fructans in the target population. | |
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Clinicaltrials.gov | Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels | Completed | Type 2 Diabetes Mellitus, Obesity | Drug - rosiglitazone | Baskent University, Other | Female | 45 Years - 65 Years | Phase 4 | Interventional | We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women. | |
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Clinicaltrials.gov | Promotion of Exercise and Health in Obesity | Unknown status | Obesity | Behavioral - SDT and Motivational Interviewing in Obesity Treatment | Technical University of Lisbon, Other | Female | 25 Years - 50 Years | N/A | Interventional | The primary objectives of this randomized clinical trial are a) to implement and test the impact of a 1-year lifestyle obesity treatment program based on Self-Determination Theory on 3-year change in physical activity and motivation for exercise/physical activity, body weight and fat, and selected eating variables, b) to identify behavioral and psychosocial theory-based moderators or mediators of primary outcomes, especially physical activity and body weight. | |
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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 | Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS | Completed | Obesity, Polycystic Ovary Syndrome | Drug - Sibutramine | Hippocration General Hospital, Other | Female | 18 Years - 40 Years | Phase 4 | Interventional | Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic features of women with polycystic ovary syndrome (PCOS) are lacking. The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on body composition, hormonal and metabolic parameters and insulin resistance in obese patients with PCOS. Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10 mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or hypocaloric diet only for the subsequent 6 months. The main outcome measures are: Body composition, hormonal and metabolic features and insulin sensitivity (OGTT) at baseline, at 3 and 6 months of treatment. | |
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Clinicaltrials.gov | Targeted Obesity Prevention Program for Adolescent Females | Completed | Obesity | Behavioral - Healthy Weight | Oregon Research Institute, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 17 Years - 19 Years | N/A | Interventional | The purpose of this study is to evaluate the effectiveness of an obesity prevention program when administered to female college freshmen. | |
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Clinicaltrials.gov | Dose-Response of Exercise on Long-Term Weight Loss | Completed | Obesity, Weight Loss | Behavioral - behavior weight loss | University of Pittsburgh, National Institutes of Health (NIH), Other, NIH | Female | 21 Years - 45 Years | Phase 1/Phase 2 | Interventional | The purpose is to examine varying durations and intensities of exercise on long-term weight loss. | |
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Clinicaltrials.gov | FirstWIND: Weight Loss Interventions After Delivery | Completed | Overweight, Obesity | Behavioral - lifestyle intervention | Johns Hopkins University, American Diabetes Association, Other, Other | Female | 18 Years - N/A | N/A | Interventional | This a pilot intervention study in which postpartum women will be randomized to receive a 6-month postpartum weight loss intervention or usual care. | |
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Clinicaltrials.gov | Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns | Completed | Overweight, Obesity | Dietary Supplement - Marinol D-40 | Technische Universität München, Else Kröner-Fresenius-Foundation, International Unilever-Foundation, Danone Research, EU funding by EARNEST consortium, German Ministry of Education and Research GF-GFGI01120708), Other, Other, Other | Female | 18 Years - 43 Years | N/A | Interventional | Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation. The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI). It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life. | |
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Clinicaltrials.gov | Evaluating the Link Between Neighborhood Environments and Obesity Among African American Women | Completed | Obesity | Boston University, National Heart, Lung, and Blood Institute (NHLBI), Other, NIH | Female | 21 Years - 69 Years | Observational | African American women have higher rates of obesity than women of any other racial or ethnic group in the United States. Obesity can have many causes, including genetic and environmental factors. This study will examine how neighborhood environments influence the occurrence of obesity among African American women. | |||
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Clinicaltrials.gov | The Effect of 5-Hydroxytryptophan (5-HTP) on Satiety | Completed | Obesity | Drug - 5-hydroxytryptophan (food supplement) | TNO, Laboratoire Oenobiol, Other, Other | Female | 18 Years - 65 Years | Phase 2 | Interventional | The aim of the study is to show evidence of the efficacy of 5-HTP to induce satiety and to reduce food intake (confirmatory study). The primary objective of the present study is to determine: - the effectiveness of a 5-HTP preparation on satiety markers (before intake of a meal and during the day) The secondary objectives of the present study are to determine the effectiveness of a 5-HTP preparation on: - food consumption (amount and composition) during a free meal (dinner); - wellness after one week supplementation; - the intermeal interval; - body weight and waist-hip ratio (WHR). | |
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Clinicaltrials.gov | Glycemic Index, Body Weight and Health | Completed | Overweight, Obesity | Behavioral - High and low glycemic index | University of Copenhagen, Danone Vitapole, France., Masterfoods Denmark, Euryza GmbH, Germany., Cerealia R&D, Schulstad Brød A/S, Denmark., Lund University Hospital, Other, Other, Other, Other, Other, Other | Female | 20 Years - 41 Years | N/A | Interventional | The purpose of this study is to investigate the effect of a diet with either high or low glycemic index (GI) on ad libitum (free) food intake, body weight, fat mass and fat-free mass, risk markers for diabetes and cardiovascular diseases, energy expenditure and substrate oxidation after 10 weeks´ intake in slightly overweight subjects. | |
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Clinicaltrials.gov | North Carolina WISEWOMAN: Weight-Wise Pilot Study | Completed | Overweight, Obesity | Behavioral - Weight loss intervention | University of North Carolina, Chapel Hill, Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services, Other, U.S. Fed, Other | Female | 40 Years - 64 Years | N/A | Interventional | The purpose of this study is to test the effectiveness of a weight loss and weight loss maintenance intervention among low income women, conducted in a community health center setting. | |
Clinicaltrials.gov | New Moves - Obesity Prevention Among Adolescent Girls | Completed | Obesity | Behavioral - New Moves | University of Minnesota, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 14 Years - 19 Years | N/A | Interventional | The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake. | |
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Clinicaltrials.gov | Treatment of Obesity in Underserved Rural Settings (TOURS) | Completed | Obesity | Behavioral, Behavioral, Other - Face-to-face counseling, Telephone counseling, Mail contact | University of Florida, National Heart, Lung, and Blood Institute (NHLBI), Other, NIH | Female | 50 Years - 75 Years | N/A | Interventional | To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties. | |
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Clinicaltrials.gov | Changes in Food Reinforcement During Obesity Treatment | Completed | Obesity | Behavioral - hypocaloric, low-fat diet | The Miriam Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Other, NIH | Female | 21 Years - 70 Years | N/A | Interventional | The reinforcing value of food, or how much a person "wants" a food, is an important determinant of food intake. Thus far, food reinforcement has only been studied in laboratory settings, and no studies have examined whether the reinforcing value of food is altered when dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat diet is implemented for weight loss may increase the reinforcing value of all foods, but particularly for restricted high-fat foods. Greater increases in the reinforcing value of high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted eating behaviors that produce weight loss, whereas greater increases in the reinforcing value of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors. The aim of this application is to measure food reinforcement in a clinical setting to determine if food reinforcement changes when a traditional weight loss diet is prescribed. For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to either a 6-month weight loss intervention or usual care. Assessments of food reinforcement, dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group changes their diet relative to the usual care group, it is hypothesized: 1) the intervention group will have greater increases in the reinforcing value of both high- and low-fat foods than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases in frequency of consumption of high-fat foods will be related to increases in the reinforcing value of high-fat foods from 0 to 6 months. These results will lead to a novel line of research, examining the relationship between food reinforcement and weight loss maintenance, so that diets can be designed to promote changes in food reinforcement that aid in sustaining dietary changes and weight loss. | |
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Clinicaltrials.gov | Epidemiology and Care of Comorbid Obesity and Depression | Completed | Obesity, Depression | Behavioral, Behavioral - Structured behavioral weight loss group, Weight loss and cognitive-behavioral depression group | Kaiser Permanente, University of Minnesota, Oregon Research Institute, Other, Other, Other | Female | 40 Years - 65 Years | N/A | Interventional | We propose to: - Conduct cross-sectional assessments of depression, disability, health-related quality of life, eating patterns, and eating attitudes in a population-based sample approximately 6000 women aged 40-60 with over-sampling of women with BMI greater than 30 kg/m2. - Among obese women free of depression, enroll approximately 100 in a 6-month standard behavior therapy weight management program. - Among obese women with significant depression, randomly assign 200 to either a 6-month standard behavior therapy weight management program or a combined cognitive-behavior therapy program focused on both depression and weight management. - Complete follow up assessments of weight, depressive symptoms, and functional status in all three treatment groups for 12 months following enrollment Screening and follow-up data will be used to address the following questions: - Association between depression and obesity among middle-aged women - Specific effects of depression and obesity on functional status, disability, and health services utilization - Impact of depression on participation in and outcomes of a standardized weight management program - Benefit of combined treatment (focused on depression and weight management) above that of standardized behavioral therapy for obese women with significant depressive symptoms. | |
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Clinicaltrials.gov | Factors Affecting Caloric Regulation in Human Feeding | Completed | Obesity | Behavioral - Reduced-energy-density diet | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH | Female | 20 Years - 60 Years | N/A | Interventional | This study will test the hypothesis that reducing the energy density of the diet by incorporating more water-rich foods will result in: 1) greater weight loss and weight maintenance; 2) greater diet satisfaction and satiety; and 3) more healthful dietary patterns than reducing dietary fat alone. | |
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Clinicaltrials.gov | Nutrition Intervention and Play Group Exercise for Low-Income Latinas | Unknown status | Obesity | Behavioral, Behavioral - Home-based nutrition sessions and play group exercise, Group-based nutrition sessions and mail-out activities | Stanford University, Other | Female | N/A - N/A | Phase 1 | Interventional | Obesity among Mexican-American women has the potential to become a public health crisis. Hispanics are one of the fastest growing minority populations in the United States and the prevalence of obesity in Mexican American woman is increasing at an alarming rate. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, and lack of exercise are thought to be associated with women's excess weight gain. Accordingly, interventions are needed to improve the dietary intake and physical activity levels of Mexican-American families. We propose to conduct a randomized clinical trial in which women are randomly assigned to receive either family-based behavioral counseling (FBC) sessions and play group physical activity sessions or group based nutrition and exercise classes and health related activity worksheets to complete with their child. The FBC sessions, conducted by community health advisors, will use photographs of the family's food practices, taken by mothers, as visual aids in the counseling sessions. The control intervention will consist of group sessions using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid recommendations using traditional Mexican-American foods. The primary outcome of the trial is mother's BMI. The secondary outcomes are dietary intake, moderate to vigorous physical activity and household food supplies. We hypothesize that within a one year time frame, women who are exposed to the FBC will have lower BMI's compared to women who receive the active placebo control intervention. The mechanisms through which we intend to change weight status are altering the type of foods purchased and cooking practices and promoting mothers to engage in physical activities with their children during their play. Measurements of secondary outcomes include three 24 hour dietary recalls, a household food inventory and activity monitoring using MTI actigraph monitors. In addition, mothers' reports of household food security level, and food purchase motives, will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up. |
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