154 Clinical Trials for Various Conditions
By doing this study, researchers hope to learn about the feasibility of using a mobile application to help overweight or obese adults with PAD increase their walking distance and lose weight.
The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC administrations in the thigh versus the abdomen in otherwise healthy overweight/obese participants (Part A) and to assess the gastrointestinal tolerability of JNJ-64565111 following a dose titration in otherwise healthy obese participants at 6 weeks (Part B).
Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors including physical activity (PA). The primary purpose of this study was to examine change in objectively measured PA in a randomized controlled pilot trial that tested a wearable sensor/device (Fitbit One) for self-monitoring and SMS text-messaging prompts to promote PA in overweight/obese adults. In a 2-group design, 67 participants were provided the Fitbit One and half were randomized to receive 3 daily SMS-based PA prompts. A Fitbit One was provided to facilitate self-monitoring with a wearable tracker for instant feedback and website of daily PA summaries. Outcome measures were number of steps and minutes of PA by intensity-level using two accelerometers: Actigraph GT3X+ (primary) at baseline and 6-week follow-up and Fitbit One (secondary) at baseline and weeks 1-6. The main hypothesis was that text messaging plus the Fitbit One would show a greater increase in steps and minutes of PA compared to only the Fitbit One at 6-week follow-up.
. The purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome
Low glycemic index nutritional shakes have clinically shown to improve post-prandial glycemic responses in acute laboratory control studies. However, there is limited information on how replacing meals with low-glycemic index shake could impact glucose regulation in free-living adults consuming their own diets. The present study aims to examine the impact of adding the SP Glucose-Assist shake to the breakfast of non-diabetic overweight and obese adults. Subjects: 40 non-diabetic adults aged 25-65 years and body mass index ranging between 25-39 . Protocol: This is going to be a three-week study that will include a one-week self-selected diet, followed by two weeks of a breakfast supplement shake (standard process glucose assist) or control cereal oat breakfast.
This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.
Over 64 million people in the U.S. have a permanent disability, with mobility-related disability (MRD) representing the most prevalent disability type (13.7%). Adults with MRD are 66% more likely to be overweight or obese than their non-disabled peers. Exercise in adults with MRD is important for weight management and is associated with improvements in obesity-related health conditions including hypertension, hyperlipidemia, insulin processing/sensitivity, etc. However, over half (57%) of adults with MRD do not exercise, while 22% engage in exercise of insufficient duration or intensity to obtain health benefits. Adults with MRD face numerous barriers to participation in community-based exercise, and exercise is frequently limited to short-term referrals for outpatient physical and/or occupational therapy. High-intensity functional training (HIFT) represents a potentially effective strategy for community-based exercise to support body weight and obesity-related health conditions, in addition to improving physical function and aspects of psychosocial health for people with disabilities. Preliminary evidence supports the effectiveness of HIFT to improve body composition, cardiovascular and muscular fitness, insulin processing and insulin sensitivity in non-disabled adults who are overweight/obese. To date, no study has systematically evaluated the feasibility or effectiveness of a community-based HIFT intervention for improving obesity-related health outcomes in overweight/obese adults with MRD. Thus, the proposed study will implement a 6-mo. pilot trial to evaluate the feasibility and potential effectiveness of a HIFT intervention (60 min sessions/3 days/wk.) in 25 adults with MRD and overweight/obesity. This study will address the following aims: Aim 1: Evaluate the intervention feasibility based on participant recruitment, session attendance, retention, outcome assessment completion, and the results of semi-structured exit interviews to obtain information regarding experience and overall satisfaction with the intervention. Aim 2: Evaluate changes (baseline - 6 mos.) in weight and fat-mass/fat-free mass, and components of the metabolic syndrome (waist circumference, blood pressure, HDL-cholesterol, triglycerides, fasting glucose).
The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants. This study also aims to collect data on safety and how tolerable the study medicine is. The study is seeking for participants who are: * Male or female who are 18 years of age or older. * Healthy but are overweight or obese. Participants will receive dabigatran and rosuvastatin as single doses by mouth 3 times during the study. The amount of the study medicine PF-07081532 will be adjusted over time until any interactions are seen. PF-07081532 is taken daily by mouth in 8 Study Periods while admitted into the study clinic over 53 days. Once discharged from the study clinic, participants will have a follow-up visit 7 to 10 days post last dose of study medicine. Then another follow-up via telephone contact, 28 to 35 days post last dose of study medicine.
This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants. The 3 study periods will be conducted consecutively without a break.
The primary objective of this trial is to examine the weight-loss efficacy of Freshly Fit meals, as well as body composition, waist/hip circumference, metabolic markers, and quality of life in overweight and obese adults.
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts: * Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1. * Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
Purpose: The investigators propose a 20-participant randomized 2-arm parallel trial with a delayed-intervention control examining how 8 weeks of moderate-intensity walking exercise alters the gut microbiome, short chain fatty acid (SCFA)-producing taxa, and the cardiometabolic profile and body weight of individuals who are overweight or obese and have prediabetes (PreD). Aim 1: Examine and compare exercise-related shifts in the gut microbiome of individuals with PreD. Aim 2: Examine and compare exercise-related changes in SCFA-producing taxa. Exploratory Aim: Examine what percentage of the exercise-related changes observed in participants' gut microbiome and SCFA-producing taxa mediate changes in their cardiometabolic profile and body weight.
Overweight and obesity prevalence in adolescents and adults continues to remain significantly high in the United States. While diet and exercise improve many consequences of obesity, dietary strategies are not always nutrient sufficient and manageable long-term. Thus, highly complaint dietary strategies that lead to fat loss, while maintaining muscle mass, are needed. Time-restricted feeding (TRF) may be an ideal dietary approach for reducing fat mass and cardiovascular disease risk, while diminishing the loss of muscle mass and strength associated with obesity and aging. TRF, unlike continuous energy restriction, does not require a restrictive energy intake10. TRF requires individuals to consume calories within a set window of time (example = 8 hours), inducing a fasting window of 16 hours per day. There are few human studies on TRF that measure their effects in combination with both aerobic and resistance training. One recent study found an 8-hour TRF program (16-hour fast) improved insulin sensitivity, decreased fat mass, and maintained muscle mass in resistance-trained males after 8 weeks. Thus, the feasibility of TRF as dietary approach should be investigated further.The aims of this study are to: 1) determine whether time-restricted feeding (TRF) is an effective dietary strategy for reducing fat mass while preserving fat-free mass with aerobic and resistance training; 2) evaluate potential changes in health-related biomarkers (cardiovascular profile and anabolic-catabolic hormones) and muscle health indicators (mass, strength and quality) after 8 weeks of concurrent training with TRF; and 3) examine the influence of caloric intake and macronutrient consumption on muscle health in the TRF and normal feeding (NF) groups pre- to post-concurrent resistance training.
This study will evaluate the main effects of daily vs. weekly feedback and contingent vs. non-contingent incentives for increasing walking behavior among overweight and obese adults.
Body-weight based interval training (IT) performed 3 times per week will lead to reductions in abdominal adiposity and reduce overall body fat percentage in overweight and obese sedentary adults more effectively than moderate intensity continuous training (MICT). Body-weight interval training will improve exercise capacity (peak VO2) in overweight/obese adults.
The proposed research will determine the feasibility of delivering two behavioral weight loss interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will also compare these two interventions in terms of safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight into a) biological changes and b) changes in kidney growth with each of the two weight loss interventions.
This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort. For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.
Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese individuals. The investigators will evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation among overweight and obese adults for outcomes related to weight management (e.g. body mass index \[BMI\], body weight, body fat percentage, waist circumference) and glucose and insulin homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance \[HOMA-IR\], fasting insulin) through systematic review and meta-analysis.
The present study is designed to examine the effect of changes in body weight and related parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter proposed to be studied here is the impact of fructose restriction and weight loss on serum uric acid concentrations and arterial stiffness.
The 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.
The purpose of this study is to determine whether introducing almonds into the diet of overweight and obese Blacks and Hispanics improves body composition, decreases liver fat, and lowers cardiovascular disease profile.
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
The purpose of this study was to examine the differences in glucose control, fitness, and body composition between a standard aerobic and resistance exercise training program and a shorter-duration, high-intensity CrossFit training program in overweight and obese physically inactive adults. Hypotheses: 1. Both groups would improve glucose control, with the CrossFit group improving significantly more than the aerobic and resistance training group. 2. Both groups would improve fitness, with the CrossFit group improving significantly more than the aerobic and resistance training group. 3. Both groups would demonstrate decreases in body fat percentage and fat mass and increases in lean body mass, with the CrossFit group improving significantly more than the aerobic and resistance training group.
The purpose of this study is to demonstrate that (1) we will observe at least 40% of the subjects in the Per Protocol population having a measured ≥5% weight loss at 16 weeks compared to week 0; and (2) the observed mean % Total Body Weight Loss at 16 weeks compared to Week 0 is ≥4% in the Per Protocol population.
Increasing physical activity in older adults has important implications for treating obesity related metabolic conditions, however the interaction of aging- and obesity-related declines in physical function may make adding structured exercise particularly challenging for this group. Given these challenges, an alternative prescription to traditional structured exercise, may be short bouts of intermittent walking scattered throughout the day - this may be an effective strategy to increase physical activity, reduce sedentary behavior, and improve glycemic control in overweight/obese older adults. The purpose of this project is to determine how interrupting sedentary time with short bouts of moderate intensity walking affects important metabolic outcomes in older, overweight adults. It would also be of interest to compare the effects of short, frequent interruptions in sedentary behavior to a traditional exercise prescription (continuous 30 min walking bout) on metabolic outcomes (e.g., glycemic control, insulin sensitivity, and 24 h fat oxidation). Thus, the overall aims of the proposed research are to 1) Determine the effect of performing short bouts of moderate-intensity intermittent walking (IW) on glucose and insulin metabolism compared to uninterrupted sitting (US) in older overweight and obese adults. 2) To compare the effects of interrupting sedentary time (IW) vs. a traditional exercise prescription (continuous 30 m walk (CW)) on metabolism. The investigators hypothesize that interrupting sedentary time with intermittent walking will improve glucose and insulin metabolism compared to uninterrupted sitting and it will be as effective at improving metabolism as a single continuous 30 min walk.
APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15 mg once daily (QD), or lorcaserin alone.
The purpose of this study is to examine the feasibility of a campaign intervention for weight management compared to a standard behavioral weight loss intervention in overweight and obese adults.
The purpose of this study is to test the effects that three different types of sweeteners have on food intake, hunger and satiety levels, as well as insulin and glucose measures. The study of whether food or beverages containing Stevia influence food intake to a greater extent than food or beverages sweetened with Aspartame or Sucrose. Also, examining whether taste preference and taste sensitivity influence food intake.
This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight. People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures: * Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days * Metabolic studies for menstruating women. * Resting metabolic rate to study how many calories the body burns at rest. * Mixed meal test to measure hormones such as insulin that regulate blood sugar. * Glucose tolerance test to determine how sensitive the body is to insulin. * 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out. * Repeat 24-hour energy expenditure. * Diurnal blood sampling and temperature assessment to study the body s internal clock. * Air-displacement plethysmography (Bod Pod) to measure body composition. * Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density. * Repeat Bod Pod and DEXA. * Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat. * Bromide dilution to measure the amount of water not in cells in the body. * Doubly labeled water to measure the amount of calories burned in a 7-day period. * 24-hour diet reports. * Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health. * Treadmill or bicycle exercise capacity test. * Physical activity monitor. * Unicorder to detect any breathing difficulties that may interfere with sleep. * Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle. * Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning. * Evaluation of mood problems and assess personality type. * Evaluation to assess the quantity and quality of pain experienced. * Taste testing to determine the response to bitter, salty, sweet and sour substances. * Occupational therapy evaluation to explore the subject s adaptations, if any, for performing personal, social or professional activities; the subject s views on his or her weight, body size and shape, and strategies to control weight.
The objective of this trial is to assess the effects of a 7-day diet containing inulin vs. a control diet on energy expenditure in adults with overweight/obesity or normal weight.