Active clinical trials for "Overweight"

Primary Specific Aim 1: To compare the dose-responsive effects of vitamin D3 supplementations on 25(OH) D, parathyroid hormone (PTH), and serum/urine calcium. Primary Specific Aim 2: To compare the dose-responsive effects of vitamin D3 supplementations on non-invasive vascular measures including pulse wave velocity (PWV), flow-mediated dilation (FMD), carotid arterial compliance (CAC), carotid Intima-Media Thickness (cIMT), and 24-hours Ambulatory Blood Pressure (ABP) monitoring as well as casual BP.

Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic risk profiles and gut microbiota in subjects with high BMI Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile acid and fecal sterol concentrations. Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal permeability in plasma; (8) inflammation Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for Enrollment Inclusion criteria: Aged 18-65 years; BMI >27 kg/m^2. Good General health. Exclusion criteria: Fasting blood glucose >300 mg/dl; triglycerides >500 mg/dl; uncontrolled hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking. Methodology After a run-in phase of two weeks, participants will be randomized to receive supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4 weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S. di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento. A 4 day-food diary record will be collected before visits T0 and T1. Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis. Safety Assessments. Adverse events. Statistical analyses. Post-intervention data will be compared by ANOVA using the General Linear Model with baseline as a covariate. Data with a skewed distribution will be log transformed before analyses. Simple and multiple linear regression will be used to determine relationships between variables and independent t-tests performed to evaluate differences in reported compliance between groups. Results will be expressed as mean +/- SEM and differences will be considered significant at P < 0.05.. Duration of Dosing. Subjects will make three visits during the study (start of run-in phase - visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6). Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is targeted.

Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period. Secondary objective is to assess the influence of potatoes' bioavailability and kinetic profiles on markers of chronic diseases.

The purpose of this study is to determine the effects of Activamp, a product containing gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy overweight adults.

It is important that individuals with serious mental illness make informed choices among alternative healthcare treatments based on their preferences. However, at present, individuals' preferences are often not being elicited, nor used to guide which treatments are made available. In this pilot project, the investigators implement and evaluate a computerized method for assessing treatment preferences of individuals with schizophrenia. The investigators use weight management treatments for this initial test of the system. If this assessment method is found to predict treatment use and satisfaction, it can be used to guide implementation of treatments that improve outcomes while meeting individuals' preferences.

Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study was designed to investigate whether consumption of onion peel extract (OPE) improves endothelial function in healthy overweight and obese subjects.

The project is designed to evaluate a participatory implementation model in HealthCorps (HC) high schools and to assess outcomes within and across school settings . The behavioral objectives from the 2010 Dietary Guidelines to address obesity in youth include: 1) decreasing sugary beverage intake; 2) increasing frequency of breakfast; 3) increasing vegetable and fruit intake to 2½ cups per day;4) decreasing frequency of fast food meals;5) becoming physically active (goal of 1 hour per day); and 6) reducing sedentary behavior time (<2 hour day). The study is employing system dynamics modeling (SDM) to assess wellness programming options and to evaluate the program implementation within the context of diverse school ecologies. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used to guide SDM development and validation. The Specific Aims are: To use PAR (Participatory Action Research) methods to refine the school wellness program model and toolkit components that address institutional/community level program implementation barriers and individual level barriers to achieving healthy lifestyle recommendations. To assess the effectiveness of program components using process evaluation techniques guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model. To evaluate implementation with system dynamics modeling to facilitate dissemination. The simulation analysis will apply the RE-AIM framework to address: Reach (participation rates), effectiveness (outcomes), adoption (acceptability), implementation (intervention fidelity), and maintenance (sustainability of lifestyle changes by students and programs by schools), in order to facilitate refining the toolkits and training program for dissemination to other school setting and diverse educational venues.

Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial was to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.

The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals. Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group

The purpose of this study is to test: Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²) Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects