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Rationale: The microbial composition in the small intestine (SI) differs largely from the composition in feces. Many physiological processes related to health, such as immunoregulation and metabolic programming, mainly take place in the SI. Therefore, the SI, from a microbiota perspective, is as relevant as the large intestine. There are indications that microbiota composition is different in lean and obese subjects, and is related to insulin resistance. However, these indications are mainly based on the analysis of fecal samples. Therefore, analysis of the microbiota composition in the more proximal part of the gastrointestinal (GI) tract may provide new insights into the microbial species that are involved or related to metabolic homeostasis at that location. The IntelliCap® CR system offers a minimally invasive tool that is able to collect reliable samples in the SI, as was shown by NIZO in a clinical validation study. The main aim of the current study is to explore and compare the upper GI microbiota composition in lean and obese subjects, in order to generate new leads for development of products that may target the upper GI microbiota community or specific species thereof, which may impact the maintenance of metabolic homeostasis. This may provide new opportunities for the treatment, reduction or prevention of overweight and/or obesity or insulin resistance.
The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.
The study will take place at a cafe managed by university dining services and is located in a university building adjacent to the psychology building. The cafe sells sugar-sweetened beverages and a variety of diet drinks. The campus dining services and the manager of the cafe have given investigators permission to "tax" their sugar sweetened beverages and will provide their sales data for a 12 week period. The investigators will introduce four arms to the experiment. One arm will be baseline data where business 'as usual' will be conducted and no price increases will be implemented on SSBs. In the general tax condition the investigators will introduce a 3 cent/ounce tax on the five SSB flavors the café offers. In the Pre-K tax condition the investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going to Pre-K education. This is designed after the Philadelphia tax that was recently passed where funds were earmarked to benefit childhood education. In the childhood healthy eating program condition the investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going toward childhood healthy eating programs. In all tax conditions the firm will keep the proceeds, but the research team will make a donation to a Pre-K education non-profit and a childhood healthy eating non-profit of the amount generated by the tax during the study period. Each experimental arm will run for 3 weeks total (for a total study period of 12 weeks). The conditions will alternate by week (i.e., week 1: business as usual; week 2: general tax; week 3: pre-K tax; week 4: childhood healthy eating tax; week 5: business as usual, etc). A research assistant will visit the café each week to make any necessary changes to signs that will label the drinks. The investigators will change the signage of the drinks in the cooler during the study period. For the baseline period there will be no changes to the signs made. Currently all beverages are labeled with their name and cost (e.g., Pepsi, $1.89). In the tax conditions the investigators will change the price of the drink (3 cents/ounce) and add a line notifying consumers of the soda 'surcharge' (note "surcharge" will be used in the study because no tax was actually passed by the local government). An example of this sign would be 'Pepsi, $2.29, includes 40 cent sugary drink surcharge.' In the Pre-K tax condition an added line will say, "Pepsi, $2.29, includes a 40 cent sugar sweetened beverage surcharge. Proceeds benefit Pre-K education." In the childhood healthy eating programs condition the text will say, "Pepsi, $2.29, includes a 40 cent sugary drink surcharge. Proceeds benefit Childhood Healthy Eating programs."
The primary objective of this study is to evaluate the Carboxipeptidase D (CPD) genotyping as a predictive biomarker of body weight and/or fat mass reduction in obese patients treated with perindopril. There is nonclinical and clinical evidence that a subgroup of human subjects may present a decrease in body weight and/or fat mass following treatment with perindopril. Although the individual characteristics that determine such effect are still unknown, Gene PreDiT SA (Biocant Park, Cantanhede, Portugal) discovered that certain genetic characteristics (e.g., single nucleotide polymorphisms (SNPs) of CPD gene) may play a role and potentially could serve as a potential predictive biomarker of response to perindopril. These promising results, along with the fact that perindopril is a medicine already in use in clinical practice, led Gene PreDiT SA to decide to proceed with the development of a theranostic approach for the treatment of obesity. Such theranostic approach consists on the use of CPD genotyping to identify obese subjects that could present improved body weight and fat mass reduction following treatment with perindopril. The current clinical trial aims to prove the concept and provide data to design further confirmatory studies. Additionally this study will evaluate the association between CPD SNPs genotypes and response to perindopril; the effect of perindopril in waist circumference, waist/hip ratio, and BMI and the tolerability and safety of perindopril in the study population.
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.
The purpose of this study is to study interactions between genes, lifestyle environmental factors like foods, nutritional supplements and non-invasive medical devices and health factors that can be measured without specialized medical equipment in order to develop lifestyle recommendations tailored to individual genetics for a host of common chronic health conditions.
This study will assess the impact of a randomized intervention aimed at increasing consumption of whole grain foods among children from low-income households that participate in the Special Nutrition Assistance Program (SNAP, or "food stamps"). A total of 60 obese children (8 to 16 years) will be recruited from a clinical population (Healthy Eating Active Living Program) at University of California San Francisco (UCSF) Benioff Children's Hospital Oakland. Participants and their caregivers will all receive education about whole grain foods, and will be randomized to either an intervention or control group. The intervention group will receive a monthly reimbursement allotment of up to 10% of their usual SNAP benefit for specific whole grain foods purchased during the three month study period. The control group will not have the financial incentive for purchasing whole grain foods during the 12 week study period. The investigators will assess the feasibility of the intervention, the impact of the intervention on household grocery purchases, and the impact on the child's anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of metabolic risk.
This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.
The goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.
The study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status.