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NCT ID: NCT04197336 Completed - Obesity Clinical Trials

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

BAE2
Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Obesity is defined as a body mass index (BMI) ≥30 kg/m2 and with a subclass of obesity known as morbid or severe obesity (BMI of ≥40 kg/m2). These are major issues in medicine for both participants and medical providers with >36% of the US population affected. Obesity is one of the biggest causes of preventable chronic diseases and healthcare costs in the USA. Obese adults spend 42% more on direct healthcare costs and morbidly obese adults overall have 81% higher healthcare costs than non-obese adults. Obesity is currently treated with dietary, pharmacological, and/or surgical approaches that are often unsuccessful or are associated with additional risks. As the incidence and prevalence of obesity and obesity-related diseases are steadily increasing, there is a growing need to detect the key risk factors involved in disease development and modify standard treatment procedures and protocols. The most successful long-term strategy continues to be bariatric and metabolic surgeries, such as sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP). The NIH recommends bariatric surgery for participants with a BMI of 40 kg/m2 or greater or a BMI of 35 kg/m2 or greater and obesity related comorbidities. These surgeries enable participants to lose between 50% and 75% of excess body weight. Despite this success, participants are apprehensive and do not undergo bariatric surgery with the biggest fear being the many complications that come with the procedure. Studies have shown that 57-77% of participants are not interested in bariatric surgery although the participants qualify.(16) With the concern of complications from bariatric surgery, interest in endoscopic bariatric techniques has increased over the years. The techniques have been shown to be efficacious, reversible, relatively safe, and cost effective. Further, these techniques offer a therapeutic window for some participants who may otherwise be unable to undergo bariatric surgery. The American Society for Gastrointestinal Endoscopy have approved endoscopic procedures, such as balloon therapy, for participants with BMI in the 30-40 kg/m2 range.(17,18) However, the products used in these therapies also have several limitations primarily the inability to provide long term weight loss given the temporary nature of these balloons.(19) Common adverse events following intragastric balloon insertion include abdominal pain (33.7%), gastroesophageal reflux disease (18.3%), anorexia, and nausea (29%). Severe complications such as gastric ulcers (2%), small bowel obstruction (0.3%), perforation (0.1%), balloon migration (1.4%), and death (0.08%) are less common. Early balloon removal occurred in 9.1% of the study participants due to participant intolerance.(20) In a pilot study to assess safety and efficacy (BEAT Obesity), 20 morbidly obese participants with a BMI of ≥40 kg/m2 with no other comorbid conditions underwent bariatric embolization and were followed for 12 months. Participants were embolized with 300-500 µm Embospheres. None of the 20 participants in the BEAT Obesity trial (the largest prospective trial to date) had any major adverse events. Any gastric ulcers that occurred (40%) were asymptomatic and were completely healed by three months after the procedure.(21) There were many limitations of this study including the absence of a control cohort and non-compliance amongst study participants. A target population of participants with a BMI of 40 kg/m2 and above was too high considering the bariatric embolization procedure is comparable to endoscopic bariatric therapies rather than bariatric surgery. BEAT Obesity excluded participants with comorbidities, such as those who suffer from diabetes, who may greatly benefit from this procedure and are often the target population for endoscopic/surgical bariatric therapies. A larger bead size of 300-500 µm was specifically chosen compared to preclinical data and prior clinical reports due to concerns of gastric ischemia and ulceration. However, smaller bead size produces greater weight loss and hormonal shifts.(22) Investigators hypothesize that transvascular bariatric embolization results in safe and effective weight loss in obese participants compared to control subjects.

NCT ID: NCT04186767 Completed - Obesity Clinical Trials

Weight Loss Impact on Male Fertility

Start date: January 10, 2019
Phase: N/A
Study type: Interventional

This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.

NCT ID: NCT04165707 Completed - Clinical trials for Overweight and Obesity

A Weight Loss RCT Comparing Keyto vs Weight Watchers

Start date: December 9, 2019
Phase: N/A
Study type: Interventional

Very low-carbohydrate ketogenic diet may have beneficial metabolic and weight loss effects, however, adhering to this diet may be challenging. Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote dietary change and weight loss. The purpose of this research is to test the Keyto self-monitoring + app intervention against a "standard of care" weight loss dietary app (Weight Watchers). 144 participants will be recruited through Facebook ads, provide online consent, and will be randomized to one of the two conditions. Weight loss after 12 weeks will be assessed as the primary outcome, with weight loss at 24 and 48 weeks being secondary outcomes. Blood samples will be collected at baseline and 12 weeks with optional blood samples at 48 weeks follow up.

NCT ID: NCT04156165 Completed - Obesity Clinical Trials

The Effect of High vs. Moderate Protein Consumption on Human Health

BEEF
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The study will be conducted as a parallel randomized controlled intervention trial, initiated by eight weeks rapid weight loss with one of two VLCDs, one week of reintroducing regular foods, and 12 weeks with one of two different ad libitum diets; in total 21 weeks. The study will be blinded for the statistician. Due to obvious different dietary intakes in the two diets, subjects cannot be blinded and neither the study personnel. As the study includes different dietary recommendations the registered clinical dietician advising the subjects cannot be blinded either. In total 110 overweight and obese volunteers will be included.

NCT ID: NCT04145466 Completed - Weight Loss Clinical Trials

The Personalized Nutrition Study

POINTS
Start date: February 27, 2020
Phase: N/A
Study type: Interventional

A person's genetic code is believed to affect how much weight he/she will lose during diets that vary in carbohydrate and dietary fat content. 'Carbohydrate responders' are hypothesized to lose more weight on diets that are high in carbohydrates, as compared to high in fats. 'Fat responders' are hypothesized to lose more weight on diets that are high in dietary fat, as compared to high in carbohydrates. The purpose of the proposed study is to test these hypotheses in a randomized controlled trial.

NCT ID: NCT04138160 Completed - Weight Loss Clinical Trials

Effects of Two Weeks of 5:2 Intermittent Energy Restriction on Basal and Postprandial Metabolism

Start date: October 18, 2018
Phase: N/A
Study type: Interventional

Worldwide, a third of adults were overweight in 2016, and 13% were obese. Excess energy intake results in weight gain. Excess fat increases the risk of disease (eg. cardiovascular diseases, type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, dementia, certain cancers). Modest weight reduction (>5% of body weight) decreases the incidence and progression of many of these diseases. Daily energy restriction or continuous energy restriction (CER) involves diets that have a 500-600 kcal deficit per day resulting in sustainable weight loss. However, adherence is difficult. Diets following a 5:2 intermittent energy restriction (5:2 IER) pattern may be better. Approximately 75% energy restriction is maintained for 2 non-consecutive days/week and normal energy intake is consumed on the remaining 5 days of the week. Significantly reduced fasting insulin concentration and insulin resistance were shown in the 5:2 IER regimen compared with the CER regimen. In this study, normal-weight young participants will be recruited and 5:2 IER and CER will be compared over 2 week periods. Subcutaneous continuous glucose monitoring (CGM) devices will be undertaken. An ad libitum pasta meal will be consumed by participants three hours after the ingestion of breakfast to evaluate the energy intake. Postprandial thermogenesis in response to the test drink will be evaluated.

NCT ID: NCT04135729 Completed - Weight Loss Clinical Trials

Mental Health in Fitness Instructors

Start date: November 1, 2019
Phase:
Study type: Observational

The aim of this project is to improve the evidence-base regarding lifestyle and mental health symptoms among fitness instructors. A national cohort of fitness instructors will be invited to participate in this study by responding to an online questionnaire. The questionnaire will consist of items regarding exercise, nutrition, eating disorders, the menstrual cycle, depression, anxiety, body dissatisfaction and satisfaction, drive for muscularity and leanness, and experiences of sexual harassment. Findings from this study will provide an evidence-base for initiatives to improve/optimize mental health among fitness instructors, and also in the process of developing fitness centres to a core partner in public health and health promotion work.

NCT ID: NCT04131426 Completed - Lung Cancer Clinical Trials

Evaluating the Combined Intervention of Nutritional Supplementation (Remune) and Exercise in Patients With Cancer Cachexia

Start date: April 24, 2020
Phase: Phase 1
Study type: Interventional

The main purpose of this research study is to determine if the use of a nutritional supplement and exercise improve or worsen cachexia.

NCT ID: NCT04127136 Completed - Obesity Clinical Trials

Analysis of the Effects of the Adana City Training and Research Hospital Obesity Center Training Program on Adult Obese Patients With Binge Eating Disorder. A Prospective, Quasi-experimental Study With Interrupted Time-series Design.

Start date: June 20, 2019
Phase: N/A
Study type: Interventional

Outcomes of treatments for binge eating spectrum eating disorders are yet to yield desirable results, reporting up to 60-70% of patients remaining symptomatic at post-treatment. Adana City Training and Research Hospital Obesity Center is designed to provide multi-disciplinary health care services and training for groups of obese patients seeking professional help. The center includes a physician, dietitian, physiotherapist, psychologist, public relations officer, and a nurse acting as a life coach. Program is planned to carry initial assessment, health screening, necessary medical attention related to obesity, cognitive change, behavioral change, and sustainability activities. The initial assessment part consisted of one on one interviews of the patient with the physician, psychologist, dietitian, physiotherapist, and the nurse. Then, the patient is consulted with an endocrinologist, cardiologist, psychiatrist, and physical therapy and rehabilitation specialist to elucidate the significant factors that resulted in excessive weight gain and barriers in losing. Patients with severe or mismanaged medical conditions, including chronic diseases, neurological diseases, significant affective and psychotic disorders, and substance abuse or addiction disorders were directed to relevant clinics before registration. The patients who completed the screening are arranged into groups and weekly group meetings are planned. In two group meetings, basic medical knowledge and frequently asked questions are discussed. The center staff and the patients get acquinted. In the following twenty weeks, trainings by the physician, dietitian, psychologist and physiotherapist are conducted about medical information about obesity, using the technology to aid weight loss, what, when, how and why to eat, nutrition groups, ration management, water consumption, self-awareness, stress management, obesity and the association between the psychological processes, warming up and mobilization, correct stance and posture, and adequate physical activity. In addition to group meetings, in monthly individual meetings, the progress of the patients are evaluated. During the course of the program the patients with BED reported improvements in BED episodes and increased weight loss rate which give the idea to conduct a study. The primary goal of the study was to analyze the change in the severity of binge eating disorder in patients registered to the program. We expected to show a decrease in the frequency of the BED episodes in all the patients. The secondary goal includes the analysis of the context of the training program to compare the effectiveness of the topics and the methods. The study was a single-arm, prospective, quasi-experimental study with interrupted time-series design. There were no sampling methods; all patients registered to the center program with binge eating disorder and completed the acquaintance step were asked to be included. Inclusion criteria were having registered to the center for training, passed the first three steps, age between 18 to 65 years, a body mass index (BMI) equal to or over 30, and having binge eating disorder. Patients who failed to attend more than four pieces of training and complete a binge eating evaluation were excluded from the study. The training materials were developed by the trainers and edited by the author for the final version before training. The cases were analyzed for the change in the severity of binge eating disorder in the program. The data collection was performed via socio-demographic information form, binge eating disorder evaluation (BEDE) form, and progress record forms. BEDE was a structured form exclusively using DSM-5 BED diagnosis and the severity criteria1. Progress record form included weekly session content that was administered by a physician, dietitian, psychologist, and the physiotherapist and the monthly individual meetings data. BEDE and progress record forms were applied before the trainings that focuses on cognitive change and repeated every four weeks for 20 weeks. The patients were planned to receive 80 hours of training by the physician, dietitian, psychologist, and the physiotherapist.

NCT ID: NCT04123938 Completed - Obesity Clinical Trials

Pea Protein and Muscle Mass During Weight Loss

Start date: October 17, 2019
Phase: N/A
Study type: Interventional

A pilot study comparing the effects of pea protein versus whey protein on the preservation of muscle mass and functionality in individuals undertaking a weight loss regimen.