70 Clinical Trials for Various Conditions
The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters. The main questions it aims to answer are: * Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR? * Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR? * Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR? Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms. Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects.
There is a critical need to develop an affordable, valid, and reliable techniques to assess free-living energy expenditure (EE), energy storage (ES), and energy intake (EI). The purpose of this project is to develop and evaluate statistical procedures to model, quantify and adjust for the measurement error of and consumer (e.g., Garmin) activity monitors and body composition scales to estimate EE and ES, and use the 'calibrated' values to estimate free-living EI.
Exercising in the fasted state results in greater fat oxidation during exercise and results in decreased caloric intake in the meals after exercise. However, the studies that examine fasted vs. fed exercise utilize a carbohydrate-based breakfast, which can increase blood glucose and insulin concentrations, which is considered a negative consequence. A protein breakfast, which can increase satiety and rest of day energy intake could also increase resting energy expenditure as well as fat oxidation during exercise. However, comparisons between fasting exercise and pre-exercise breakfast macronutrient intake (i.e., carbohydrate vs. protein) have not been made. Therefore the purpose of this study is to investigate if eating breakfast and the composition of this breakfast before exercise has an effect on the food eaten throughout the rest of the day.
This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.
Weight gain following antiretroviral therapy (ART) initiation occurs with all modern regimens. Recent real-world reports suggest that integrase strand transfer inhibitor (INSTI)-based ART may be associated with excess weight gain compared to other regimens. Weight gain appears to occur regardless of baseline weight, and is most pronounced among women and minorities, often those at highest risk of obesity-associated comorbidities. INSTI- and TAF-based regimens are now preferred regimens for most persons according to the Department of Health and Human Services ART-Treatment Guidelines. As a result, there is an urgent need to understand the underlying mechanisms for this weight gain. This study aims to understand the changes in energy balance that occur with changes in ART. Participants with HIV who have experienced \>10% weight gain on INSTI (bictegravir or dolutegravir-based therapy) will be switched to doravirine for 12 weeks, and then back to their prior INSTI regimen, allowing for assessment of changes in metabolic parameters with drug withdrawal and reintroduction (with no change to NRTI-backbone). Twenty-four hour energy balance will be measured on both regimens during a 24-hour stay using a whole room indirect calorimetry, with a standardized diet. Ultimately, the investigator's goal is to understand the mechanisms of weight gain so that future interventions can most effectively mitigate ART-associated weight changes.
This research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (\~15% oxygen; achieved with nitrogen dilution, equivalent to \~8500 feet elevation) and another night in NN (control) conditions (\~20% oxygen; achieved with nitrogen dilution, equivalent to \~1000 feet elevation).
This study will test will how eating on a particular daily schedule may effect energy, weight gain or loss, and body temperature.
The purpose of this study is to apply measurement error techniques on consumer devices to assess rate of energy storage \[ES\] and energy expenditure \[EE\], then estimate EI using the intake-balance technique. The goal of this study is to develop calibration models that will be able to be translated to other consumer devices with only minor modifications given common hardware (e.g. triaxial accelerometry), resulting in overall improved ability to assess energy balance and EI at a population level and positive health outcomes.
Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.
The effects of prolonged negative energy balance, commonly observed in sustained military training and combat operations, on systemic inflammatory responses has not been determined. To define the putative role of energy balance on inflammation and its downstream effects, we will conduct a controlled laboratory study that simulates extensive physiological stressors to determine if inflammation is exacerbated by underfeeding. This design will test the hypothesis that maintaining energy balance will attenuate systemic inflammation and its potential negative effects on whole-body metabolic homeostasis in response to physiological stressors.
A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.
The purpose of this study is to measure the metabolic phenotype of a range of body weights in individuals with and without type 1 diabetes.
The study will examine the mechanisms linking race, stress and biobehavioral factors to energy balance and obesity in both natural and controlled environments in African-American and Caucasian adolescent females. A Hispanic/Latina cohort has recently been added with permission for the sponsor.
The study team will assess "free-living" 24h glucose control using continuous glucose monitors (CGM) over an 88h period on two separate occasions. Importantly, standardized meals will be provided and will be consumed at specific times each day of the CGM measurement period. These meals will be identical on day 1 and day 3 of measurement. Each subject will complete two CGM periods, which will be identical except for the calorie and macronutrient content of the post-exercise dinner. In addition, during trial 1, two CGM's will be worn, while only 1 CGM will be worn on trial 2.
We propose to study the role of the gut microbiome in the development of obesity, and whether we can change the microbiome's contribution to host energy balance through diet. We have created a novel model that explicitly links the effects of microorganisms on human energy balance and modeled weight change, and will use the power of metabolic ward studies to measure small changes in energy absorption, total daily energy expenditure, and/or food intake that affect long-term weight gain or loss. By integrating clinical measurements, bioreactor experiments, and mathematical modeling, we will be able to describe cause-and-effect mechanisms that will enable a quantification of the microbiota's contribution to weight gain and inspire future studies on the interactions of diet, the gut microbiome, and human physiology.
The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week open label extension. Following baseline testing, 48 patients will be randomly assigned with equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week open label extension during which all patients receive ExQW. Changes of weight status, body composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW), activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose tolerance and hormonal parameters of energy homeostasis and insulin resistance will be assessed before treatment and at the end of the placebo-controlled phase (week 36). Activity, metabolic outcomes, energy intake will be also assessed at study week 18 (mid treatment of randomized study), as well as week 54 (end of open label treatment).
The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative multi-component intervention focused on increasing energy expenditure and re-balancing the disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing workers' abdominal obesity.
The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.
Ivacaftor is a novel, FDA approved new therapy that addresses Cystic fibrosis transmembrane conductance regulator (CFTR) dysfunctions in subjects with Cystic fibrosis (CF) and "gating mutations". The primary aim is to determine the mechanism(s) for weight gain in participants whom Ivacaftor treatment was initiated based on clinical indications by CF Care Team. This longitudinal study will assess in detail energy expenditure, weight gain, body composition, and lung function in 24 subjects ≥6 years old with CF with a gating mutation before treatment and after three months treatment with Ivacaftor. All subjects will be seen at the Children's Hospital of Philadelphia's Clinical Translational Research Center.
The Quit \& Fit intervention will be designed as a 12-week study to promote smoking cessation, increase physical activity levels, and reduce weight gain through regular exercise and healthy nutrition for African American Women smokers. Patients will be assigned to the fitness intervention group or control groups by a computer.
RATIONALE: Obesity and overweight are associated with the risk of aggressive disease, and energy balance may play a major role in prostate cancer progression. PURPOSE: Randomized phase II trial to study the effectiveness of weight loss, via a healthy energy-restricted diet and exercise, in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults. This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late). The Aims and Hypotheses of this study are: Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing. * Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile. * Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin. Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing. • Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.
The purpose of this study if to determine the specific contributions of energy intake and energy expenditure to changes in body weight and fat.
The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.
The primary purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another primary purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet. A secondary aim will be to test the reliability and validity of the Actical accelerometer, SenseWear Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated energy expenditure or posture allocation from the 3 devices is associated with weight change during and following a low calorie diet (LCD).
This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).
The purpose of this study is to compare a diet containing whole grains versus an energy matched diet using refined grains on body composition and metabolism.
This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and fat regain following a period of moderate, yet clinically significant weight loss.
The purpose of this research study is to examine the effects of overfeeding and exercise on blood levels of hormones associated with regulating appetite, also thought of as feelings of hunger and satiety (fullness). Previous studies have shown that non-obese people have different amounts of these hormones in their blood compared to obese people. The investigators hypothesize that exercise will promote improved insulin sensitivity and corresponding beneficial changes in obese individuals. The investigators predict exercise induced changes in 24-hour plasma hormone levels will be associated with improved appetite during overfeeding in obese individuals.