Treatment Trials

176 Clinical Trials for Various Conditions

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SUSPENDED
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Description

Background: In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home. Objective: To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks. Eligibility: Adults aged 19 to 50 years with a body mass index of 25 or more. Design: Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples. Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered. Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....

RECRUITING
Intermittent Fasting on Body Fat and Quality of Life
Description

The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

Conditions
RECRUITING
Dietary Supplementation on Body Fat Composition
Description

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

COMPLETED
Evaluation of the Accuracy of a Computer Vision-based Tool for Assessment of Total Body Fat Percentage
Description

This research study is designed to validate the precision and accuracy of body measurement and composition results from a novel 2D imaging device that operates through a smart-phone application. Measurement references will be obtained through dual energy x-ray absorptiometry, air displacement plethysmography, bioelectrical impedance analysis, manual anthropometry, and previously validated 3D optical scanners.

Conditions
COMPLETED
Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study
Description

The overall goal is to determine the real-world feasibility and utility of body fat imaging using rapid MRI to enhance risk perception, induce behavioral change, and improve clinical outcomes in overweight and obese individuals. Here, the investigators will perform a pragmatic clinical effectiveness pilot trial using a 2x2 factorial design to test the hypothesis that provision of a detailed individualized visual report of body fat distribution directly to patients will translate into changes in patient risk perception, behavior, and improved clinical outcomes.

TERMINATED
A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat Percentage
Description

This study is being done to test whether a HealthReel computer vision-based software application can estimate body fat percentage with equivalent accuracy to a whole body dual energy x-ray absorptiometry scan.

Conditions
RECRUITING
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
Description

Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. 60 adolescents and young adults with CF will be recruited, and 30 volunteers without cystic fibrosis. A total of 40 of these study participants with CF will be asked to return for annual study visits for 2 years after the first visit. The long-term goal of this study is to use the information collected to make decisions about future nutrition monitoring and interventions which help maintain optimal health for individuals with CF.

Conditions
ACTIVE_NOT_RECRUITING
Serial Assessment of Body Fat Accrual in Very Preterm Infants
Description

Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. The study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.

COMPLETED
Measurement of Body Fat in Infants
Description

Up to 10 infants will complete the study aimed to establish a technique for measuring whole body adiposity and brown adipose tissue in infant subjects using dual energy x-ray absorptiometry and magnetic resonance imaging, respectively.

COMPLETED
Eating Frequency and Visceral Adipose Tissue, Body Fat, and Obesity Risk in Hispanic College Freshmen
Description

Due to the increased focus on education and changing lifestyle, college students are particularly susceptible to poor overall health and wellness due to inadequate sleep and poor dietary choices. This is particularly important because the behavioral choices college students make may affect their risk of chronic disease. This study will research these topics via an online survey, in person visit and stool sample.

COMPLETED
Menopausal Sleep Fragmentation and Body Fat Gain
Description

This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

Conditions
COMPLETED
Impact of Liraglutide 3.0 on Body Fat Distribution
Description

This study is a clinical study to investigate the efficacy of liraglutide compared to placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk for cardiovascular disease after 40 weeks on-treatment.

COMPLETED
Body Fat Reducing Effect and Safety of Enzymatically Modified Isoquercitrin in Overweight and Obese Subjects
Description

The purpose of this clinical study is to determine the effect and safety of long-term intake of enzymatically modified isoquercitrin (EMIQ), a natural plant product on body fat loss in obese and overweight individuals.

Conditions
COMPLETED
Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss
Description

The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15% vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%; 28days) in overweight individuals. We hypothesize that HP will elicit more favorable body composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of change will be greatest in those consuming HP meals more frequently.

Conditions
COMPLETED
Heat Wrap Device Safety With Age and Body Fat
Description

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Conditions
COMPLETED
Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat
Description

The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous fat is often popularly referred to as "Lipodissolve" therapy. Despite its attractiveness as an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections might work remain unclear. This study will investigate the hypothesis that injections of PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible for the fat loss will be explored to find out whether fat cells die from toxic effects or are broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the study, including photography and measurement of patients, tissue biopsy, blood tests, and MRI. The study will also record side effects of the treatments as well as patient satisfaction.

COMPLETED
Percent Body Fat in Breast Fed Infants
Description

The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies.

Conditions
COMPLETED
Diet, Exercise and Body Fat in 3-5 Year Olds
Description

To determine how practical and precise different body composition methods are for measuring body fat and lean tissue in young children and to determine if certain dietary factors and physical activity patterns are related to body fat in children.

Conditions
COMPLETED
Calcium, Dairy, and Body Fat in Adolescents
Description

Lifestyle choices,including diet,are conducive to healthy body weights in children. Dairy products and calcium supplementation have been associated with moderation of body weight and body fat. This study was designed to test the following hypotheses with overweight and obese adolescents consuming a controlled diet: * Dietary calcium supplementation as calcium carbonate or dairy calcium modulates energy balance in adolescents. * Increased calcium in the diet of adolescents will increase fecal fat excretion and thereby decrease fat absorption. * Calcium and dairy product supplementation will increase lipid oxidation resulting in an increase in energy expenditure.

COMPLETED
Effect of Conjugated Linoleic Acid on Body Fat in Overweight Children
Description

The prevalence of overweight children has increased dramatically over the last decade, and many overweight children will remain overweight as adults. Conjugated linoleic acid (CLA), a naturally occurring dietary fatty acid, has shown promising results in reducing body fat among adults, and we propose to test the efficacy of CLA supplementation on body fat accretion in 6 to 10 year old children who are overweight or at risk of overweight.

Conditions
UNKNOWN
Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations
Description

The purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age. Compensation to Eligible Participants: 1. FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00. 2. Each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical purposes of $0.20 per mile. This compensation will be provided to each eligible participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00, contingent upon his or her completion in the study.

Conditions
COMPLETED
An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation
Description

The investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. There are also data to suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation. These and other activities of PPARs are being further explored in this clinical study.

COMPLETED
Validation of Methods to Estimate Body Fat
Description

The purpose of this study is to evaluate various methods for estimating body composition in human subjects. Each subject is evaluated by several methods that are then compared to a criterion value. We hypothesize that the prediction method will yield the same result as the criterion value. The risks to subjects are minimal and all techniques are routinely performed.

Conditions
COMPLETED
Effects of Regular Activity on Physiology Between Recreational Athletes of Different Body Fatness
Description

The popularity of marathons and endurance events has increased over the last few decades and, interestingly, the demographics of participants have also changed. From 1980 to 2002 the average race time to complete the marathon lengthened from \~3.5 hours to \~4.5 hours. Likewise, many endurance races include "Clydesdale" and "Athena" divisions for heavier weight male and female runners, respectively. As such, there has been an increase of overweight and obese participants in these races. For example, one study consisting of 250 runners determined, according to BMI, that approximately 15% and 31% of the female and male participants, respectively, were classified as overweight, with 31% and 33% classified as obese. Therefore, many recreational endurance athletes are overweight despite their high level of activity. On one hand, these data are positive as regular exercise reduces cardiovascular disease and all-cause mortality in overweight and obese populations. Yet, it is well documented in sedentary obese individuals that excess adiposity can lead to disturbances in adipocyte lipolysis and altered substrate utilization at rest and during exercise, and can decrease muscle quality. However, it is unknown if overweight individuals that exercise regularly have disrupted fat metabolism, circulating hormones, or muscle quality. No study has directly determined if differences exist in fat metabolism, circulating hormones, and muscle quality between overweight recreational female athletes and their lean counterparts when training status is equivalent. Therefore, the purpose of this investigation is to determine if differences in pre and post-exercise fat metabolism, circulating insulin and growth hormone, and muscle quality exist between active overweight individuals compared to active lean individuals with similar training history and who have regularly trained for and participated in endurance events within the last few years.

COMPLETED
Effects on Cellulite Appearance
Description

Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.

TERMINATED
Multi-Center Traditional Feasibility Study of Radiofrequency Device
Description

This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the abdominal area.

Conditions
COMPLETED
Multi-Center Pivotal Study of Radiofrequency Device
Description

This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the flank (love handle) area.

Conditions
COMPLETED
CoolSculpting System
Description

Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.

COMPLETED
CoolSculpting and RF for the Submental
Description

The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.

COMPLETED
CoolSculpting and EMS for the Abdomen
Description

Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.