Active clinical trials for "Obesity"

Overweight and obesity due to food that exceeds the requirements is an increasingly common global problem. Lifestyle intervention and anorectic drugs result in minimal weight loss, which tends to be easily regained. In addition, drugs tend to have too many side effects and have had to be withdrawn from management schemes and even from the market. Disulfiram (Antabuse®️) is approved by the Food and Drug Administration against chronic alcohol addiction. In a mouse study, disulfiram prevented body weight gain and negated the adverse impact of an obesogenic diet on insulin; used properly it is a safe drug. Carrying out a testing-concept study with disulfiram will allow the establishment of guidelines on clinical studies focused on its use as an adjunct in the reduction and control of body weight.

The objective of this double-blind, parallel, randomized placebo-controlled clinical trial is to evaluate the effects of consumption of polyphenol-rich cranberry extract standardized in PACs (36 mg PACs/capsule) on cardiometabolic and neurocognitive health in women and men presenting abdominal obesity over an 8-week intervention period. The study will be conducted at Quebec Heart and Lung Institute - Laval University. The study will involve a total of 60 adult men and women presenting abdominal obesity. Included participants will be randomly assigned to the consumption of a cranberry extract or a placebo at a rate of one capsule per day for 8 weeks (56 days). The main outcomes are changes in metabolic profile, neurocognitive performance as well as brain structure and function following polyphenol-rich cranberry extract standardized in PACs compared with the placebo.

The researchers will conduct 'Taxi ROADmAP (Realizing Optimization Around Diet And Physical activity)', which also utilizes MOST, and the same 4 obesity intervention components as in SANOS, but targets the overweight/obesity crisis in another at-risk, low socioeconomic status (SES) population, taxi and for-hire vehicle (FHV) drivers (Lyft, Uber, etc.). ROADMAP also utilizes an effectiveness- implementation hybrid type 1 design. Hybrid trials, which blend effectiveness and implementation studies, can lead to more rapid translational uptake and more effective implementation. Taxi and FHV drivers are a growing, multilingual, hard-to-reach, predominantly immigrant and minority essential worker population. There are over 750,000 licensed taxi and FHV drivers in in the U.S. and over 185,000 in New York City (NYC). They have higher rates of overweight/obese range body mass index (BMI) than New Yorkers in general (77% vs 56%) and have high rates of elevated waist circumference, sedentary behavior, poor diets, and health care services underutilization. ROADmAP will test 4 evidence- and theory-based (Social Cognitive Theory [SCT]) behavior change intervention components. We will use MOST to identify which of the 4 components contribute most significantly and cost-effectively to weight loss among NYC drivers recruited at workplace health fairs (HFs) and virtually. Objectives are to apply MOST to design an optimized version of a scalable, lifestyle intervention for taxi/FHV drivers, and then to conduct a mixed methods multistakeholder process evaluation to facilitate widespread intervention implementation.

The goal of this randomized clinical trial is to compare an antiinflammatory and environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to antiinflammatory responses with an active control diet based on general healthy diet recommendations (CONV-D) in adults from 18 to 50 years of age with obesity (body mass index ≥30 kg/m2). The main questions it aims to answer are: If the intervention with AIA-D will cause a significant decrease at the end of the intervention (six weeks) in lipopolysaccharide-binding protein (LBP) compared to CONV-D. If intervention with AIA-D will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of two specific bacteria genera (AM and FP) when compared to CONV-D. Participants will: Sign the informed consent. Provide two peripheral blood samples (taken by our trained professionals). Provide two samples of feces. Allow anthropometric (body weight, height, hip and waist circumferences) blood pressure measurements on two occasions. Respond to 24 h dietary recall on two occasions. Attend the 1-hour group sessions requested (three for AIA-D and one for CONV-D). Follow the dietary recommendations provided. Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention. Researchers will compare an antiinflammatory and environmentally friendly strategy (AIA-D) with an active control diet (CONV-D) based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP, compared to CONV-D.

The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.

The implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). The literature shows that adults participating in cooking workshops are satisfied and acquire cooking skills potentially useful for improving their health (WOLFSON, BLEICH, 2015; CARAHER, 1999). REICKS (2014, 2018) and REES (2012) point out, however, the low methodological quality of most of the studies conducted and, in fact, the effectiveness of therapeutic cooking workshops has not been formally demonstrated by rigorous randomized studies. The Care and Prevention Research Unit (CRESP) of the Manhès Hospital Center then built a multicenter research protocol to demonstrate the impact of cooking workshops in the care of patients with obesity. The protocol involves 6 hospitals: Georges Pompidou European Hospital (HEGP) University Hospital Center (department of Prof S. CZERNICHOW), PITIE SALPETRIERE University Hospital Center (department of Prof J.M. OPPERT), Cognacq Jay Hospital Center, Forcilles Hospital Center, Bligny Hospital Center and Manhes Hospital Center . The CuisTO protocol was selected by the PHRIP Jury of the DGOS (General Direction of the Care Offer French Ministry of Health) in 2019 as a high priority project. The main objective of this research is to evaluate the effectiveness of remote cooking workshops in the management of obesity, through two methods of setting up therapeutic cooking workshops (so-called "classic" workshops and workshops in the form of "culinary challenges") to improve dietary balance in the context of the care of adult patients living with obesity. Dietary balance will be estimated by compliance with the recommendations of the latest National Health Nutrition Program (PNNS-4 2019-2023), "judged" by the PNNS-GS2 score, the consumption of fruits and vegetables, the frequency of cooking and a reduction in the consumption of ultra-processed dishes that have already been prepared. This is a multicentre, open-label, controlled, comparative intervention study with sequential randomization in clusters (clusters) of the "stepped wedge" type

In the U.S., dietary fructose has increased in parallel with the increase in obesity and may promote the development of diabetes and other chronic diseases. The largest source of dietary fructose is sweetened beverages that are consumed by adolescents more than any other age group. This protocol will compare the rates of hepatic de novo lipogenesis (DNL), a process in the liver that changes sugar into fat, in two groups of obese adolescents - one with prediabetes and the other, metabolically healthy. Blood will be sampled before and hourly for 3 hours after the consumption of a fructose-containing beverage. We hypothesize that the pre-diabetic group will show greater DNL in response to fructose. This would support other evidence that increased fructose-induced hepatic DNL is an early mechanism linking dietary sugar to the adverse metabolic sequelae of obesity, including diabetes, fatty liver, dyslipidemia and coronary disease.

Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Early DKD is characterized by changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure with resultant hyperfiltration, is common in Y-T2D, and predicts progressive DKD. Studies evaluating the two currently approved medications for treating T2D in youth (metformin and insulin) have shown these medications are not able to improve β-cell function over time in the youth. However, recent evidence suggests that bariatric surgery in adults is associated with improvements in diabetes outcomes, and even T2D remission in many patients. Limited data in youth also supports the benefits of bariatric surgery, regarding weight loss, glycemic control in T2D, and cardio-renal health. While weight loss is important, the acute effect of bariatric surgery on factors such as insulin resistance likely includes weight loss-independent mechanisms. A better understanding of the effects of bariatric surgery on pancreatic function, intrarenal hemodynamics, renal O2 and cardiovascular function is critical to help define mechanisms of surgical benefits, to help identify potential novel future non-surgical approaches to prevent pancreatic failure, DKD and cardiovascular disease. The investigators' overarching hypotheses are that: 1) Y-T2D is associated with IR, pancreatic dysfunction, intrarenal hemodynamic dysfunction, elevated renal O2 consumption and cardiovascular dysfunction which improve with bariatric surgery, 2) The early effect of bariatric surgery on intrarenal hemodynamics is mediated by improvement in IR and weight loss. To address these hypotheses, the investigators will measure GFR, RPF, glomerular pressure and renal O2, in addition to aortic stiffness, β-cell function and insulin sensitivity in youth ages 12-21 with T2D (n=30) before and after vertical sleeve gastrectomy (VSG). To further investigate the mechanisms of renal damage in youth with T2D, two optional procedures are included in the study prior to vertical sleeve gastrectomy: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.

In this study, we will address cost barriers to participating in summer programs and hypothesize this will lead to marked improvements in children's obesogenic behaviors and a reduction in excessive, unhealthy weight gain over summer.

Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. Recent studies have indicated tocotrienols (one kind of vitamin E, a potent antioxidant) supplement may be good for mitigating negative impacts of obesity in postmenopausal women. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators will enroll 60 qualified women at the start of the study and randomly assigned to no tocotrienols (placebo) or tocotrienols group for 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. All data will be analyzed statistically.