Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals
ObesityOverweightThis study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).
Text Messaging for Physical Activity & Healthy Eating
OverweightHispanics share a disproportionate burden of several of the nation's leading chronic diseases caused by poor lifestyle habits such as sedentary behavior and poor quality nutrition intake. This project will design, implement and evaluate the delivery and effectiveness of an existing health promotion text messaging program focused on increasing physical activity and improving dietary behaviors among medically underserved Hispanic patients. Adult Hispanic patients referred by their healthcare provider at a local free community health clinic will be invited to participate in the 4-month long study. Patients who agree to participate will be sent health promotion text messages and will complete a brief pre-post assessment battery. Patients who do not send an initial enrollment text (to agree to participate) will receive a follow up telephone call from the research team to encourage participation. Evaluations will consist of: (1) physician referral rates; (2) patient enrollment rates; (3) demographic differences (gender, age) in participants/non-participants; and (4) pre-post changes in levels of physical activity and quality dietary intake will be conducted. The results of this study will provide a better understanding of the feasibility and effectiveness of implementing referral-based text messaging programs among medically underserved Hispanic patients at high risk for chronic diseases.
Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and...
Healthy VolunteersThe purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the same.
Breakfast Meal Replacement
Body CompositionBeneficial4 morePurpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high fiber meal replacement in overweight individuals, on body composition. Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of disease. Procedures (methods): In a randomized control intervention, subjects will complete 5 different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing sessions) as well as an 8 week intervention period. Pre-screening will include written informed consent, health history questionnaire, nutrition analysis, and baseline anthropometric measures. Baseline testing will be split into two sessions and include measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones, mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory fitness assessment. Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement to be taken at breakfast) and control groups (continue normal eating habits) with 4 electronic correspondences throughout the supplementation period. All measures will be repeated in two post-testing sessions.
Health Effects of Coffee Consumption
OverweightEpidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.
The Effect of Variety on Physical Activity
OverweightIncreasing physical activity continues to be a challenge among many individuals, particularly those who are overweight. Recent data from the National Health and Nutrition Examination Survey (NHANES) showed that individuals who reported engaging in a variety of activities were more likely to meet national physical activity recommendations compared to those who reported no variety. Incorporating a variety of activities into a physical activity program may be a way to increase physical increase physical activity levels. One method to increase variety in physical activities is to use active videogames. Videogames that use motion sensors allow a gamer to physically perform a variety of activities. Thus, the purpose ot this laboratory-based investigation is to conduct a study to examine the effect of engaging in a greater variety of active videogames on energy expenditure in 30 non-obese, regularly active adults.
Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on...
OverweightHealthy SubjectsStudy 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.
Active Commuting To Improve Well-being and Health in Everyday Life
Overweight and ObesityThe 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
Motivation to Exercise
OverweightObesity1 moreThe purpose of this study is to understand how to make exercise more attractive to people.
Effect of Dietary Habits on Metabolic Health
OverweightObesity2 moreThe goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.